product atalog - zydus pharmaceuticals usa, inc.€¦ · nd strength size ase description/imprint...
TRANSCRIPT
Product Catalog Summer 2014
New Products: Etodolac ER Tablets Bupropion HCl ER Tablets
Coming Soon: Niacin ER Tablets
2 | w w w . z y d u s u s a . c o m
NDC Strength Size Case Description/Imprint Code
Acetazolamide Extended-Release Capsules
AB-Rated to Diamox® Sequels
68382-0261-01 500mg 100 24 Capsule; Orange Opaque/White Opaque; EP/107
Amiodarone HCl Tablets
AB-Rated to Cordarone® Tablets
68382-0227-14 200mg 60 24 Round; White to Off-White; Bisect, ZE 65
68382-0227-05 200mg 500 12 Round; White to Off-White; Bisect, ZE 65
Amlodipine Besylate Tablets
AB-Rated to Norvasc® Tablets
68382-0121-16 2.5mg 90 24 Round; White to Off-White; Z/7
68382-0121-05 2.5mg 500 12 Round; White to Off-White; Z/7
68382-0122-16 5mg 90 24 Round; White to Off-White; Z3
68382-0122-05 5mg 500 12 Round; White to Off-White; Z3
68382-0123-16 10mg 90 24 Round; White to Off-White; Z5
68382-0123-05 10mg 500 12 Round; White to Off-White; Z5
Anastrozole Tablets
AB-Rated to Arimidex® Tablets
68382-0209-06 1mg 30 24 Round; White; A7
68382-0209-10 1mg 1000 12 Round; White; A7
Atenolol Tablets, USP
AB-Rated to Tenormin® Tablets
68382-0022-01 25mg 100 24 Round; White to Off-White; Z/65
68382-0022-10 25mg 1000 12 Round; White to Off-White; Z/65
68382-0023-01 50mg 100 24 Round; White to Off-White; Bisect, Z 66
68382-0023-10 50mg 1000 12 Round; White to Off-White; Bisect, Z 66
68382-0024-01 100mg 100 24 Round; White to Off-White; Z 67
68382-0024-10 100mg 1000 12 Round; White to Off-White; Z 67
Azathioprine Tablets, USP
AB-Rated to Imuran® Tablets
68382-0003-01 50mg 100 24 Round; Yellow, Bisect; ZC 59
68382-0003-05 50mg 500 12 Round; Yellow, Bisect; ZC 59
Benzonatate Capsules, USP
AA-Rated to Tessalon® Perles
68382-0247-01 100mg 100 24 Round; Light Yellow; Z
68382-0247-05 100mg 500 12 Round; Light Yellow; Z
68382-0248-01 200mg 100 24 Round; Light Yellow; β
3 | w w w . z y d u s u s a . c o m
NDC Strength Size Case Description/Imprint Code
Bromocriptine Mesylate Capsules, USP
AB-Rated to Parlodel® Capsules
68382-0110-06 5mg 30 24 Capsule; White to Off-White; ZA 17
68382-0110-01 5mg 100 24 Capsule; White to Off-White; ZA 17
Bupropion Extended-Release Tablets
AB-Rated to Wellbutrin XL® Extended-Release Tablets
68382-0354-06 300mg 30 24 Round; Creamy-white to Pale-Yellow; 354
68382-0354-05 300mg 500 12 Round; Creamy-white to Pale-Yellow; 354
Carvedilol Tablets
AB-Rated to Coreg® Tablets
68382-0092-01 3.125mg 100 24 Round; White to Off-White; Z/1
68382-0092-05 3.125mg 500 12 Round; White to Off-White; Z/1
68382-0093-01 6.25mg 100 24 Round; White to Off-White; ZC40
68382-0093-05 6.25mg 500 12 Round; White to Off-White; ZC40
68382-0094-01 12.5mg 100 24 Round; White to Off-White; ZC41
68382-0094-05 12.5mg 500 12 Round; White to Off-White; ZC41
68382-0095-01 25mg 100 24 Round; White to Off-White; ZC42
68382-0095-05 25mg 500 12 Round; White to Off-White; ZC42
Clarithromycin for Oral Suspension, USP
Same as Biaxin® Granules for Oral Suspension
68382-0764-05 125mg/5mL 50 mL 48 White to off-white granules; Fruit Punch flavor
68382-0764-06 125mg/5mL 100 mL 48 White to off-white granules; Fruit Punch flavor
68382-0765-05 250mg/5mL 50 mL 48 White to off-white granules; Fruit Punch flavor
68382-0765-06 250mg/5mL 100 mL 48 White to off-white granules; Fruit Punch flavor
Clarithromycin Tablets, USP
Same as Biaxin® Filmtab®
68382-0761-14 250mg 60 48 Oval; Yellow; Abbott Logo KT
68382-0762-14 500mg 60 48 Oval; Yellow; Abbott Logo KL
Dipyridamole Tablets, USP
AB-Rated to Persantine® Tablets
68382-0187-01 25mg 100 24 Round; Light Yellow; ZE 43
68382-0188-01 50mg 100 24 Round; Light Yellow; ZE 49
68382-0189-01 75mg 100 24 Round; Light Yellow; ZE 50
4 | w w w . z y d u s u s a . c o m
NDC Strength Size Case Description/Imprint Code
Divalproex Sodium Capsules (Sprinkle) AB-Rated to Depakote® Sprinkle Capsules
68382-0106-01 125mg 100 24 Capsule; Blue/White; ZA66/125mg
68382-0106-10 125mg 1000 12 Capsule; Blue/White; ZA66/125mg
Divalproex Sodium Delayed-Release Tablets, USP
AB-Rated to Depakote® Delayed-Release Tablets
68382-0031-01 125mg 100 24 Oval; White to Off-White; ZA08
68382-0031-05 125mg 500 12 Oval; White to Off-White; ZA08
68382-0032-01 250mg 100 24 Oval; White to Off-White; ZA07
68382-0032-05 250mg 500 12 Oval; White to Off-White; ZA07
68382-0033-01 500mg 100 24 Oval; White to Off-White; ZA06
68382-0033-05 500mg 500 12 Oval; White to Off-White; ZA06
Divalproex Sodium Extended-Release Tablets
Same as Depakote® Extended-Release Tablets
68382-0314-01 250mg 100 Ovaloid; White; “a” logo HF
68382-0315-01 500mg 100 Ovaloid; Gray; “a” logo HC
68382-0315-05 500mg 500 Ovaloid; Gray; “a” logo HC
Donepezil HCl Orally Disintegrating Tablets
AB-Rated to Aricept ODT®
68382-0346-06 5mg 30 24 Round; White to Off-White; ZF14
68382-0347-06 10mg 30 24 Round; White to Off-White; ZF15
Etodolac Extended-Release Tablets
AB-Rated to Lodine XL® Extended-Release Tablets
68382-0271-14 400mg 60 24 Oval; Orange; 271
68382-0271-01 400mg 100 12 Oval; Orange; 271
68382-0272-14 500mg 60 24 Oval; Grey; 272
68382-0272-01 500mg 100 12 Oval; Grey; 272
68382-0273-14 600mg 60 24 Oval; Blue; 273
68382-0273-01 600mg 100 12 Oval; Blue; 273
5 | w w w . z y d u s u s a . c o m
NDC Strength Size Case Description/Imprint Code
Famotidine for Oral Suspension, USP
AB-Rated to Pepcid® for Oral Suspension
68382-0444-05 40mg/5mL 50 mL 24 White to Off-White; Cherry-Mint flavor
Fenofibrate Tablets
Same as TriCor® Tablets
68382-0228-16 48mg 90 Oval; Yellow; “a” logo/FI
68382-0230-16 145mg 90 Oval; White; “a” logo/FO
Fenofibric Acid Delayed-Release Capsules
Same as Trilipix® Delayed-Release Capsules
68382-0077-16 45mg 90 Capsule; Reddish-brown/Yellow; “a” logo/45
68382-0078-16 135mg 90 Capsule; Blue/Yellow; “a” logo/135
Gabapentin Tablets
AB-Rated to Neurontin® Tablets
68382-0204-01 600mg 100 24 Oval; White to Off-White; ZE72 bisect/bisect
68382-0204-05 600mg 500 12 Oval; White to Off-White; ZE72 bisect/bisect
68382-0205-01 800mg 100 24 Oval; White to Off-White; ZE71 bisect/bisect
68382-0205-05 800mg 500 12 Oval; White to Off-White; ZE71 bisect/bisect
Galantamine HBr Tablets, USP
AB-Rated to Razadyne® Tablets
68382-0177-14 4mg 60 24 Round; Light Pink; 77/Z
68382-0178-14 8mg 60 24 Round; Off-White; 78/Z
68382-0179-14 12mg 60 24 Round; Off-White; 79/Z
Haloperidol Tablets, USP
AB-Rated to Haloperidol Tablets, USP
68382-0080-01 10mg 100 24 Capsule; Light Green, Partial Bisect; ZC 08
68382-0081-01 20mg 100 24 Capsule; Coral, Bisect; ZC 09
Hydroxychloroquine Sulfate Tablets, USP
AB-Rated to Plaquenil® Tablets
68382-0096-01 200mg 100 24 Capsule; White to Off-White; ZC38
68382-0096-05 200mg 500 12 Capsule; White to Off-White; ZC38
6 | w w w . z y d u s u s a . c o m
NDC Strength Size Case Description/Imprint Code
Lamotrigine Chewable Dispersible Tablets
AB-Rated to Lamictal® Chewable Dispersible Tablets
68382-0108-01 5mg 100 24 Round; White to Off-White; Bisect, Z 13
68382-0109-01 25mg 100 24 Round; White; Z 12
Lamotrigine Tablets
AB-Rated to Lamictal® Tablets
68382-0006-01 25mg 100 24 Round; White to Off-White; Bisect, ZC 79
68382-0006-10 25mg 1000 12 Round; White to Off-White; Bisect, ZC 79
68382-0008-01 100mg 100 24 Round; White to Off-White; Bisect, ZC 80
68382-0008-10 100mg 1000 12 Round; White to Off-White; Bisect, ZC 80
68382-0009-14 150mg 60 24 Round; White to Off-White; Bisect, ZC 81
68382-0009-05 150mg 500 12 Round; White to Off-White; Bisect, ZC 81
68382-0010-14 200mg 60 24 Round; White to Off-White; Bisect, ZC 82
68382-0010-05 200mg 500 12 Round; White to Off-White; Bisect, ZC 82
Lansoprazole Delayed-Release Capsules, USP
AB-Rated to Prevacid® Delayed-Release Capsules
68382-0543-06 15mg 30 24 Capsule; Opaque Pink/Opaque White; ZA-50/15mg
68382-0543-10 15mg 1000 12 Capsule; Opaque Pink/Opaque White; ZA-50/15mg
68382-0544-06 30mg 30 24 Capsule; Opaque Pink/Opaque White; ZA-51/30mg
68382-0544-01 30mg 100 24 Capsule; Opaque Pink/Opaque White; ZA-51/30mg
68382-0544-10 30mg 1000 12 Capsule; Opaque Pink/Opaque White; ZA-51/30mg
Levofloxacin Tablets
AB-Rated to Levaquin® Tablets
68382-015-18 250mg 50 24 Modified Capsule; White to Off-White; ZC55
68382-015-01 250mg 100 24 Modified Capsule; White to Off-White; ZC55
68382-016-18 500mg 50 24 Modified Capsule; White to Off-White; ZC56
68382-016-01 500mg 100 24 Modified Capsule; White to Off-White; ZC56
68382-017-18 750mg 50 24 Modified Capsule; White to Off-White; ZC57
68382-017-01 750mg 100 24 Modified Capsule; White to Off-White; ZC57
Losartan Potassium and Hydrochlorothiazide Tablets, USP
AB-Rated to Hyzaar® Tablets
68382-0142-06 50/12.5mg 30 24 Capsule; White to Off-White; ZD18
68382-0142-16 50/12.5mg 90 24 Capsule; White to Off-White; ZD18
68382-0142-10 50/12.5mg 1000 12 Capsule; White to Off-White; ZD18
7 | w w w . z y d u s u s a . c o m
NDC Strength Size Case Description/Imprint Code
Losartan Potassium and Hydrochlorothiazide Tablets, USP (continued) AB-Rated to Hyzaar® Tablets
68382-0143-06 100/25mg 30 24 Capsule; White to Off-White; ZD19
68382-0143-16 100/25mg 90 24 Capsule; White to Off-White; ZD19
68382-0143-10 100/25mg 1000 12 Capsule; White to Off-White; ZD19
Losartan Potassium Tablets, USP AB-Rated to Cozaar® Tablets
68382-0135-06 25mg 30 24 Capsule; White to Off-White; Z/2
68382-0135-16 25mg 90 24 Capsule; White to Off-White; Z/2
68382-0135-01 25mg 100 24 Capsule; White to Off-White; Z/2
68382-0135-10 25mg 1000 12 Capsule; White to Off-White; Z/2
68382-0136-16 50mg 90 24 Capsule; White to Off-White; Z16/Breakline
68382-0136-01 50mg 100 24 Capsule; White to Off-White; Z16/Breakline
68382-0136-10 50mg 1000 12 Capsule; White to Off-White; Z16/Breakline
68382-0137-06 100mg 30 24 Capsule; White to Off-White; Z18
68382-0137-16 100mg 90 24 Capsule; White to Off-White; Z18
68382-0137-01 100mg 100 24 Capsule; White to Off-White; Z18
68382-0137-10 100mg 1000 12 Capsule; White to Off-White; Z18
Meloxicam Tablets, USP
AB-Rated to Mobic® Tablets
68382-0050-01 7.5mg 100 24 Round; Yellow; ZC 25
68382-0050-05 7.5mg 500 12 Round; Yellow; ZC 25
68382-0051-01 15mg 100 24 Round; Yellow; ZC 26
68382-0051-05 15mg 500 12 Round; Yellow; ZC 26
Metformin HCl Tablets, USP
AB-Rated to Glucophage® Tablets
68382-0028-01 500mg 100 24 Round; White to Off-White; 70/Z
68382-0028-05 500mg 500 12 Round; White to Off-White; 70/Z
68382-0028-10 500mg 1000 12 Round; White to Off-White; 70/Z
68382-0029-01 850mg 100 24 Oval; White to Off-White; 69/Z
68382-0029-05 850mg 500 12 Oval; White to Off-White; 69/Z
68382-0029-10 850mg 1000 12 Oval; White to Off-White; 69/Z
68382-0030-01 1000mg 100 24 Oval; White to Off-White; Bisect, Z 71
68382-0030-05 1000mg 500 12 Oval; White to Off-White; Bisect, Z 71
68382-0030-10 1000mg 1000 12 Oval; White to Off-White; Bisect, Z 71
8 | w w w . z y d u s u s a . c o m
NDC Strength Size Case Description/Imprint Code
Omeprazole Delayed-Release Capsules, USP
AB-Rated to Prilosec® Capsules
68382-0411-06 10mg 30 24 Capsule; Amethyst Purple/White; ZA-09/10 mg
68382-0411-01 10mg 100 24 Capsule; Amethyst Purple/White; ZA-09/10 mg
68382-0412-06 20mg 30 24 Capsule; Tan/White; ZA-10/20 mg
68382-0412-01 20mg 100 24 Capsule; Tan/White; ZA-10/20 mg
68382-0412-10 20mg 1000 12 Capsule; Tan/White; ZA-10/20 mg
68382-0500-06 40mg 30 24 Capsule; Amethyst Purple/White; ZA-11/40 mg
68382-0500-01 40mg 100 24 Capsule; Amethyst Purple/White; ZA-11/40 mg
68382-0500-10 40mg 1000 12 Capsule; Amethyst Purple/White; ZA-11/40 mg
Oxycodone HCl Tablets, USP AB-Rated to Roxicodone® Tablets
68382-0793-01 5mg 100 12 Round; Orange; NP, Partial Bisect/11
68382-0794-01 10mg 100 12 Round; Pink; NP, Partial Bisect/12
68382-0795-01 15mg 100 12 Round; Yellow; NP, Partial Bisect/13
68382-0796-01 20mg 100 12 Round; Gray; NP, Partial Bisect/14
68382-0797-01 30mg 100 12 Round; White; NP, Partial Bisect/15
Paricalcitol Capsules
AB-Rated to Zemplar® Capsules
68382-0266-06 1mcg 30 48 Capsule; Gray; “a” logo ZA
68382-0267-06 2mcg 30 48 Capsule; Orange-Brown; “a” logo ZF
Paroxetine Tablets, USP
Same as Paxil® Tablets
68382-0097-06 10mg 30 24 Round; White to Off-White; Bisect, ZC 15
68382-0097-16 10mg 90 24 Round; White to Off-White; Bisect, ZC 15
68382-0097-05 10mg 500 12 Round; White to Off-White; Bisect, ZC 15
68382-0097-10 10mg 1000 12 Round; White to Off-White; Bisect, ZC 15
68382-0098-06 20mg 30 24 Round; White to Off-White; Bisect, ZC 16
68382-0098-16 20mg 90 24 Round; White to Off-White; Bisect, ZC 16
68382-0098-01 20mg 100 24 Round; White to Off-White; Bisect, ZC 16
68382-0098-05 20mg 500 12 Round; White to Off-White; Bisect, ZC 16
68382-0098-10 20mg 1000 12 Round; White to Off-White; Bisect, ZC 16
NDC Strength Size Case Description/Imprint Code
Paroxetine Tablets, USP (continued) Same as Paxil® Tablets
68382-0099-06 30mg 30 24 Round; White to Off-White; ZC17
68382-0099-16 30mg 90 24 Round; White to Off-White; ZC17
68382-0099-05 30mg 500 12 Round; White to Off-White; ZC17
68382-0099-10 30mg 1000 12 Round; White to Off-White; ZC17
68382-0001-06 40mg 30 24 Round; White to Off-White; ZC18
68382-0001-16 40mg 90 24 Round; White to Off-White; ZC18
68382-0001-05 40mg 500 12 Round; White to Off-White; ZC18
Potassium Chloride Extended-Release Capsules, USP
Same as Micro-K® Extencaps® Extended-Release Capsules, USP
68382-0702-01 8mEq (600mg) 100 12 Capsule; Pale Orange; 002/002
68382-0701-01 10mEq (750mg) 100 12 Capsule; Pale Orange/Opaque White; 001/001
68382-0701-05 10mEq (750mg) 500 12 Capsule; Pale Orange/Opaque White; 001/001
Potassium Chloride Extended-Release Tablets, USP
Same as K-Tab® Extended-Release Tablets
68382-0600-01 10mEq (750mg) 100 48 Ovaloid; Yellow; “a” logo/K-TAB
68382-0600-10 10mEq (750mg) 1000 12 Ovaloid; Yellow; “a” logo/K-TAB
68382-0398-01 20mEq (1500mg) 100 48 Ovaloid; White; K-TAB
68382-0398-05 20mEq (1500mg) 500 12 Ovaloid; White; K-TAB
Pramipexole Dihydrochloride Tablets
AB-Rated to Mirapex® Tablets
68382-0196-16 0.125mg 90 24 Capsule; Pink; P1
68382-0196-10 0.125mg 1000 12 Capsule; Pink; P1
68382-0197-16 0.25mg 90 24 Round; Pale Blue; P2/Bisect
68382-0197-10 0.25mg 1000 12 Round; Pale Blue; P2/Bisect
68382-0198-16 0.5mg 90 24 Capsule; Lavender; P3/Bisect
68382-0198-10 0.5mg 1000 12 Capsule; Lavender; P3/Bisect
68382-0199-16 1mg 90 24 Round; Light Peach to Peach; P4/Bisect
68382-0199-10 1mg 1000 12 Round; Light Peach to Peach; P4/Bisect
9 | w w w . z y d u s u s a . c o m
10 | w w w . z y d u s u s a . c o m
NDC Strength Size Case Description/Imprint Code
Pramipexole Dihydrochloride Tablets (continued) AB-Rated to Mirapex® Tablets
68382-0200-16 1.5mg 90 24 Round; Yellow; P5/Bisect
68382-0200-10 1.5mg 1000 12 Round; Yellow; P5/Bisect
Pravastatin Sodium Tablets, USP
AB-Rated to Pravachol® Tablets
68382-0070-16 10mg 90 24 Oval; White to Off-White; ZC46
68382-0070-05 10mg 500 12 Oval; White to Off-White; ZC46
68382-0071-16 20mg 90 24 Oval; White to Off-White; ZC45
68382-0071-05 20mg 500 12 Oval; White to Off-White; ZC45
68382-0072-16 40mg 90 24 Oval; White to Off-White; ZC44
68382-0072-05 40mg 500 12 Oval; White to Off-White; ZC44
68382-0073-16 80mg 90 24 Oval; White to Off-White; ZC43
68382-0073-05 80mg 500 12 Oval; White to Off-White; ZC43
Promethazine HCl Tablets, USP
AB-Rated to Phenergan® Tablets
68382-0040-01 12.5mg 100 24 Round; White to Off-White; Bisect, ZC 01
68382-0041-01 25mg 100 24 Round; White to Off-White; Quadrisect, Z C 0 2
68382-0041-10 25mg 1000 12 Round; White to Off-White; Quadrisect, Z C 0 2
68382-0042-01 50mg 100 24 Round; White to Off-White; ZC 03
Ramipril Capsules
AB-Rated to Altace® Capsules
68382-0144-06 1.25mg 30 24 Capsule; White Opaque/Yellow Opaque; ZA-43/1.25 mg
68382-0144-01 1.25mg 100 24 Capsule; White Opaque/Yellow Opaque; ZA-43/1.25 mg
68382-0144-05 1.25mg 500 12 Capsule; White Opaque/Yellow Opaque; ZA-43/1.25 mg
68382-0145-06 2.5mg 30 24 Capsule; White Opaque/Orange Opaque; ZA-44/2.5 mg
68382-0145-01 2.5mg 100 24 Capsule; White Opaque/Orange Opaque; ZA-44/2.5 mg
68382-0145-05 2.5mg 500 12 Capsule; White Opaque/Orange Opaque; ZA-44/2.5 mg
68382-0146-06 5mg 30 24 Capsule; White Opaque/Red Opaque; ZA-45/5 mg
68382-0146-01 5mg 100 24 Capsule; White Opaque/Red Opaque; ZA-45/5 mg
68382-0146-05 5mg 500 12 Capsule; White Opaque/Red Opaque; ZA-45/5 mg
11 | w w w . z y d u s u s a . c o m
NDC Strength Count Case Description/Imprint Code
Ramipril Capsules (continued) AB-Rated to Altace® Capsules
68382-0147-06 10mg 30 24 Capsule; White Opaque/Blue Opaque; ZA-46/10 mg
68382-0147-01 10mg 100 24 Capsule; White Opaque/Blue Opaque; ZA-46/10 mg
68382-0147-05 10mg 500 12 Capsule; White Opaque/Blue Opaque; ZA-46/10 mg
Ranitidine Injection, USP
AP-Rated to Zantac® Injection
68382-0422-02 25mg/mL 2 mL 1 SD vial, 10 vials per carton
68382-0423-06 25mg/mL 6 mL 12 MD vial, single vial
Ribavirin Capsules
AB-Rated to Rebetol® Capsules
68382-0260-12 200mg 84 24 Capsule; White/White; ZA-12/200mg
Ribavirin Tablets
AB-Rated to Copegus® Tablets
68382-0046-03 200mg 168 24 Round; Light Pink to Pink; ZC19
Risperidone Orally Disintegrating Tablets
AB-Rated to Risperdal® M-Tab® Orally Disintegrating Tablets
68382-0154-06 0.5mg 30 24 Round; White to Off-White; ZD22
68382-0155-06 1mg 30 24 Round; White to Off-White; ZD21
68382-0156-06 2mg 30 24 Round; White to Off-White; ZD20
Risperidone Tablets, USP AB-Rated to Risperdal® Tablets
68382-0112-14 0.25mg 60 24 Round; Dark Yellow; Z/4
68382-0112-05 0.25mg 500 12 Round; Dark Yellow; Z/4
68382-0113-14 0.5mg 60 24 Round; Red-Brown; Z/6
68382-0113-05 0.5mg 500 12 Round; Red-Brown; Z/6
12 | w w w . z y d u s u s a . c o m
NDC Strength Count Case Description/Imprint Code
Risperidone Tablets, USP (continued) AB-Rated to Risperdal® Tablets
68382-0114-14 1mg 60 24 Round; White to Off-White; ZC75
68382-0114-05 1mg 500 12 Round; White to Off-White; ZC75
68382-0115-14 2mg 60 24 Round; Orange; ZC76
68382-0115-05 2mg 500 12 Round; Orange; ZC76
68382-0116-14 3mg 60 24 Round; Yellow; ZC77
68382-0116-05 3mg 500 12 Round; Yellow; ZC77
68382-0117-14 4mg 60 24 Round; Green; ZC78
68382-0117-05 4mg 500 12 Round; Green; ZC78
Simvastatin Tablets, USP
AB-Rated to Zocor® Tablets
68382-0065-16 5mg 90 24 Oval; White; ZA19
68382-0065-10 5mg 1000 12 Oval; White; ZA19
68382-0066-16 10mg 90 24 Oval; Pink; ZA20
68382-0066-05 10mg 500 12 Oval; Pink; ZA20
68382-0066-10 10mg 1000 12 Oval; Pink; ZA20
68382-0067-16 20mg 90 24 Oval; Brown; ZA21
68382-0067-05 20mg 500 12 Oval; Brown; ZA21
68382-0067-10 20mg 1000 12 Oval; Brown; ZA21
68382-0068-16 40mg 90 24 Oval; Pink; ZA22
68382-0068-05 40mg 500 12 Oval; Pink; ZA22
68382-0068-10 40mg 1000 12 Oval; Pink; ZA22
68382-0069-16 80mg 90 24 Capsule; White to Off-White; ZA23
68382-0069-05 80mg 500 12 Capsule; White to Off-White; ZA23
68382-0069-10 80mg 1000 12 Capsule; White to Off-White; ZA23
Sirolimus Tablets
AB-Rated to Rapamune® Tablets
68382-0520-01 0.5mg 100 24 Round; Yellow; 1
Tamsulosin HCl Capsules, USP
AB-Rated to Flomax® Capsules
68382-0132-01 0.4mg 100 24 Capsule; Green/Peach; ZA-18/0.4 mg
68382-0132-10 0.4mg 1000 12 Capsule; Green/Peach; ZA-18/0.4 mg
13 | w w w . z y d u s u s a . c o m
NDC Strength Count Case Description/Imprint Code
Topiramate Capsules (Sprinkle) AB-Rated to Topamax® Sprinkle Capsules
68382-0004-14 15mg 60 24 Capsule; White Opaque/White Opaque; ZA63/15 mg
68382-0005-14 25mg 60 24 Capsule; White Opaque/White Opaque; ZA63/15 mg
Topiramate Tablets
AB-Rated to Topamax® Tablets
68382-0138-14 25mg 60 24 Round; White to Off-White; ZD 16
68382-0138-05 25mg 500 12 Round; White to Off-White; ZD 16
68382-0139-14 50mg 60 24 Round; White to Off-White; ZD 15
68382-0139-05 50mg 500 12 Round; White to Off-White; ZD 15
68382-0140-14 100mg 60 24 Round; White to Off-White; ZD 14
68382-0140-05 100mg 500 12 Round; White to Off-White; ZD 14
68382-0141-14 200mg 60 24 Round; White to Off-White; ZD 13
68382-0141-05 200mg 500 12 Round; White to Off-White; ZD 13
Tramadol HCl Tablets
AB-Rated to Ultram® Tablets
68382-0319-01 50mg 100 24 Round; White to Off-White; 319
68382-0319-05 50mg 500 12 Round; White to Off-White; 319
68382-0319-10 50mg 1000 12 Round; White to Off-White; 319
Tramadol HCl/Acetaminophen Tablets
AB-Rated to Ultracet® Tablets
68382-0334-01 37.5/325mg 100 24 Capsule-shaped; White; 334
68382-0334-10 37.5/325mg 1000 12 Capsule-shaped; White; 334
Venlafaxine HCl Extended-Release Capsules
AB-Rated to Effexor XR® Extended-Release Capsules
68382-0034-06 37.5mg 30 24 Capsule; Grey/White; ZA-35/37.5 mg
68382-0034-16 37.5mg 90 24 Capsule; Grey/White; ZA-35/37.5 mg
68382-0034-10 37.5mg 1000 12 Capsule; Grey/White; ZA-35/37.5 mg
68382-0035-06 75mg 30 24 Capsule; Peach/White; ZA-36/75 mg
68382-0035-16 75mg 90 24 Capsule; Peach/White; ZA-36/75 mg
68382-0035-10 75mg 1000 12 Capsule; Peach/White; ZA-36/75 mg
68382-0036-06 150mg 30 24 Capsule; Dark Orange/White; ZA-37/150 mg
68382-0036-16 150mg 90 24 Capsule; Dark Orange/White; ZA-37/150 mg
68382-0036-10 150mg 1000 12 Capsule; Dark Orange/White; ZA-37/150 mg
14 | w w w . z y d u s u s a . c o m
NDC Strength Count Case Description/Imprint Code
Venlafaxine HCl Tablets
AB-Rated to Effexor® Tablets
68382-0018-01 25mg 100 24 Round; Peach; Bisect, ZC 64
68382-0019-01 37.5mg 100 24 Round; Peach; Bisect, ZC 65
68382-0020-01 50mg 100 24 Round; Peach; Bisect, ZC 66
68382-0021-01 75mg 100 24 Round; Peach; Bisect, ZC 67
68382-0101-01 100mg 100 24 Round; Peach; Bisect, ZC 68
Warfarin Sodium Tablets, USP
AB-Rated to Coumadin® Tablets
68382-0052-01 1mg 100 24 Oval; Pink; Bisect, WAR 1
68382-0052-10 1mg 1000 12 Oval; Pink; Bisect, WAR 1
68382-0053-01 2mg 100 24 Oval; Lavender; Bisect, WAR 2
68382-0053-10 2mg 1000 12 Oval; Lavender; Bisect, WAR 2
68382-0064-01 2.5mg 100 24 Oval; Green; Bisect, WAR 2½
68382-0064-10 2.5mg 1000 12 Oval; Green; Bisect, WAR 2½
68382-0054-01 3mg 100 24 Oval; Tan; Bisect, WAR 3
68382-0054-10 3mg 1000 12 Oval; Tan; Bisect, WAR 3
68382-0055-01 4mg 100 24 Oval; Blue; Bisect, WAR 4
68382-0055-10 4mg 1000 12 Oval; Blue; Bisect, WAR 4
68382-0056-16 5mg 90 24 Oval; Peach; Bisect, WAR 5
68382-0056-01 5mg 100 24 Oval; Peach; Bisect, WAR 5
68382-0056-10 5mg 1000 12 Oval; Peach; Bisect, WAR 5
68382-0057-01 6mg 100 24 Oval; Teal; Bisect, WAR 6
68382-0058-01 7.5mg 100 24 Oval; Yellow; Bisect, WAR 7½
68382-0059-01 10mg 100 24 Oval; White; Bisect, WAR 10
Zolmitriptan Orally Disintegrating Tablets
AB-Rated to Zomig-ZMT® Orally Disintegrating Tablets
68382-0715-86 2.5mg 1x6
Blister Pack
72 Round; White/mottled white to cream; 715
68382-0717-82 5mg 1x3
Blister Pack
72 Round; White/mottled white to cream; 717
15 | w w w . z y d u s u s a . c o m
Therapeutic Category Generic Name Brand
Analgesic Etodolac Extended-Release Tablets Lodine XL® Extended-Release Tablets
Analgesic Meloxicam Tablets Mobic® Tablets
Analgesic Oxycodone HCl Tablets, USP Roxicodone® Tablets
Analgesic Tramadol HCl Tablets, USP Ultram® Tablets
Analgesic Tramadol HCl/Acetaminophen Tablets Ultracet® Tablets
Antiarrhythmic Amiodarone HCl Tablets Cordarone® Tablets
Antibiotic Clarithromycin for Oral Suspension, USP Biaxin® Granules for Oral Suspension
Antibiotic Clarithromycin Tablets, USP Biaxin® Filmtab®
Antibiotic Levofloxacin Tablets Levaquin® Tablets
Anticoagulant Warfarin Sodium Tablets, USP Coumadin® Tablets
Anticonvulsant Divalproex Sodium Capsules (Sprinkle) Depakote® Sprinkle Capsules
Anticonvulsant Divalproex Sodium Delayed-Release Tablets, USP Depakote® Delayed-Release Tablets
Anticonvulsant Divalproex Sodium Extended-Release Tablets Depakote® Extended-Release Tablets
Anticonvulsant Gabapentin Tablets Neurontin® Tablets
Anticonvulsant Lamotrigine Chewable Dispersible Tablets Lamictal® Chewable Dispersible Tablets
Anticonvulsant Lamotrigine Tablets Lamictal® Tablets
Anticonvulsant Topiramate Capsules (Sprinkle) Topamax® Sprinkle Capsules
Anticonvulsant Topiramate Tablets Topamax® Tablets
Antidepressant Bupropion Extended-Release Tablets Wellbutrin XL® Extended-Release Tablets
Antidepressant Paroxetine Tablets, USP Paxil® Tablets
Antidepressant Venlafaxine HCl Extended-Release Capsules Effexor XR® Extended-Release Capsules
Antidepressant Venlafaxine HCl Tablets Effexor® Tablets
Antiglaucoma Agent Acetazolamide Extended-Release Capsules Diamox® Sequels
Antihyperlipidemic Fenofibrate Tablets TriCor® Tablets
Antihyperlipidemic Fenofibric Acid Delayed-Release Capsules Trilipix® Delayed-Release Capsules
Antihyperlipidemic Pravastatin Sodium Tablets, USP Pravachol® Tablets
Antihyperlipidemic Simvastatin Tablets, USP Zocor® Tablets
Antihypertensive Ramipril Capsules Altace® Capsules
Antimalarial Hydroxychloroquine Sulfate Tablets, USP Plaquenil® Tablets
Antimigraine Zolmitriptan Orally Disintegrating Tablets Zomig-ZMT® Orally Disintegrating Tablets
Antineoplastic Agent Anastrozole Tablets Arimidex® Tablets
Antiparkinson Agent Bromocriptine Mesylate Capsules, USP Parlodel® Capsules
Antiparkinson Agent Pramipexole Dihydrochloride Tablets Mirapex® Tablets
Antipsychotic Haloperidol Tablets, USP Haloperidol Tablets, USP
Antipsychotic Risperidone Orally Disintegrating Tablets Risperdal® M-Tab® Orally Disintegrating Tablets
Antipsychotic Risperidone Tablets, USP Risperdal® Tablets
Antirheumatic, Cytotoxic Azathioprine Tablets, USP Imuran® Tablets
Antitussive Benzonatate Capsules, USP Tessalon® Perles
16 | w w w . z y d u s u s a . c o m
Therapeutic Category Generic Name Brand
Antiviral Ribavirin Capsules Rebetol® Capsules
Antiviral Ribavirin Tablets Copegus® Tablets
Benign Prostatic Hypertrophy Agent Tamsulosin HCl Capsules, USP Flomax® Capsules
Cardiovascular Agent Amlodipine Besylate Tablets Norvasc® Tablets
Cardiovascular Agent Atenolol Tablets, USP Tenormin® Tablets
Cardiovascular Agent Carvedilol Tablets Coreg® Tablets
Cardiovascular Agent Losartan Potassium and Hydrochlorothiazide Tablets, USP
Hyzaar® Tablets
Cardiovascular Agent Losartan Potassium Tablets, USP Cozaar® Tablets
Central Nervous System Agent Donepezil HCl Orally Disintegrating Tablets Aricept ODT®
Cholinesterase Inhibitor Galantamine HBr Tablets, USP Razadyne® Tablets
Electrolyte Supplement Potassium Chloride Extended-Release Capsules, USP Micro-K® Extencaps® Extended-Release Capsules
Electrolyte Supplement Potassium Chloride Extended-Release Tablets, USP K-Tab® Tablets
Gastric Acid Secretion Inhibitor Famotidine for Oral Suspension, USP Pepcid® for Oral Suspension
Gastrointestinal Agent Lansoprazole Delayed-Release Capsules, USP Prevacid® Delayed-Release Capsules
Gastrointestinal Agent Omeprazole Delayed-Release Capsules, USP Prilosec® Delayed-Release Capsules
Gastrointestinal Agent Promethazine HCl Tablets, USP Phenergan® Tablets
Gastrointestinal Agent Ranitidine Injection, USP Zantac® Injection
Hypoglycemic Metformin HCl Tablets, USP Glucophage® Tablets
Immune Suppressant Sirolimus Tablets Rapamune® Tablets
Platelet Aggregation Inhibitor Dipyridamole Tablets, USP Persantine® Tablets
Vitamin D Analog Paricalcitol Capsules Zemplar® Capsules
17 | w w w . z y d u s u s a . c o m
Ordering Information Customer Service Zydus Pharmaceuticals (USA) Inc. N114 W18850 Clinton Drive Germantown, WI 53022 Hours of Operation: 8:00 AM – 7:00 PM CST Phone: 877-ZYDUS RX, Prompt 1 (877-993-8779, Prompt 1) Fax: 877-993-9055
Remit To 1 EAB Plaza P.O. Box #10004 Uniondale, NY 11555-10004
Minimum Order Requirements The minimum order for each SKU is one case pack (usually a quantity of 12, 24, or 48). The total order must exceed $1,000.00. All orders will be shipped on a prepaid basis utilizing the method of transportation selected by Zydus Pharmaceuticals. In cases where customer requests are expedited, more expensive, or special handling of an order, Zydus Pharmaceuticals reserves the right to charge the customer for these expenses.
Returns Please refer to the following page or the Zydus website, www.zydususa.com, for the current Return Goods Policy.
Zydus Pharmaceuticals (USA) Inc. Return Goods Policy
This return goods policy applies to all ZyGeneric (68382) and Nesher (51477) labeled pharmaceutical products. All ZyGeneric and
Nesher product returns must be sent prepaid to our designated return goods processor to the following address: Inmar- South Dock, 4332 Empire Road, Fort Worth, TX 76155. Zydus does not pay fees such as processing charges for returning any product other than recalled product. For customers using other return companies for processing and destruction Zydus will not assume responsibility for charges incurred.
Request for Return Authorizations (box labels) can be made by any of the below methods:
1. Accessing the Inmar website at https://clsnetlink.com (you will need to upload a PDF copy of your debit memo)
2. E-mail your debit memo to [email protected]. Be sure to include NDC#, lot# and expiration dates assigned to each item. 3. Fax your debit memo to Inmar at 817-868-5343
Returnable Items (For Reimbursement):
· Products within six (6) months of expiration date and up to 12 months after the expiration date stated on the package.
Products must be in sealed, full, unopened, original Zydus or Nesher containers.
· Products received in error or damaged in shipping to consignee (accompanied by a signed bill of lading noting such damage)
if reported to Zydus customer service within 5 days of receipt and returned within 30
· Prior written approval is required for all return of all overstocked product with greater than 12 months expiration dating. his merchandise
will be subject to a 15% restocking fee.
· A DEA Form 222 is required in order to return C-II controlled substances. Please send DEA Form 222 requests to : Fax # (817) 868-5342
or E-mail: [email protected] Returnable Items (No Credit):
· Products returned without an approved Product Return Form.
· Products sold on a non-returnable basis, professional sample, or free goods.
· Partial or open bottles, except where required by law. · Product which has been repackaged, product purchased through a bankruptcy sale, fire sale, distress merchandise, or product not in original container are not eligible for credit. Zydus will not credit for product damaged due to insurable causes such as fire, floods or earthquake. · Products with broken seals, opened, coded, dated, damaged or missing label, or soiled packages.
· Products damaged at customers warehouse or store, or not stored under proper conditions.
· Products with greater than six months expiration dating or are greater than 12 months past the expiration date.
· Private label products.
· Return of over stocked product without prior written approval of Zydus · Merchandise distributed contrary to federal, state or local laws.
· Product not purchased from either Zydus or the customer’s authorized distributor / wholesaler. Valuation of Returns:
· Direct buying customers will be issued a credit by Zydus. This credit will be issued at the lowest of either original invoice price or the
prevailing contract price on the date the goods are returned to Zydus.
· Non-Direct customers will receive credit directly from Inmar. If no contract exists, the credit will be issued based upon the lower of the
current Zydus standard market price at the time the returned merchandise is received by Inmar OR the original Zydus contract price at
point of purchase from the wholesaler. Transportation Charges
· Prepaid by customer, unless shipped in error by Zydus.
· Returned product shipped collect will be refused.
Miscellaneous: · Representatives cannot authorize return of in date product or pick up merchandise.
· Returned products will be promptly evaluated and credit will reflect eligibility and / or ineligibility. All products returned, whether
eligible for credit or not, become property of Zydus. All products are returned with the understanding that they are subject to final re-
view and evaluation by Zydus, and will be processed in accordance with the most recent return policy in effect at the time of the return.
· Wholesalers are not authorized to accept returns of Zydus products except in the case of mis-shipments or other ordering errors.
· Zydus reserves the right to amend this policy at any time.
· Claim merchandise-even exchange or credit will be allowed for loss or damage evident at delivery time if noted on the
carrier’ delivery receipt and reported to us within five days. Concealed loss or damage must be inspected by carrier within 5 days after delivery and carrier’s inspection report must be forwarded to Zydus USA.
· Zydus USA policy strictly prohibits any sales representative or any other employee from giving samples or stock packages to any customer
to replace merchandise. All returns must be made according to this return goods policy.
Revised Effective 07/25/2013
18 | w w w . z y d u s u s a . c o m
19 | w w w . z y d u s u s a . c o m
Contact Information
Customer Service
Medical Affairs
Returns
Address Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534
Telephone 609-730-1900
Fax 609-730-1998
Website www.zydususa.com
Telephone 877-993-8779, Prompt 1
Fax 877-993-9055
Email [email protected]
Telephone 877-993-8779, Prompt 2
Fax 678-581-4401
Email [email protected]
Inmar 800-967-5952
Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 Phone: 609-730-1900 Fax: 609-730-1998 www.zydususa.com