catalog of products not approved by the fda · 2020. 11. 17. · to learn more or place an order,...
TRANSCRIPT
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CATALOG OF PRODUCTS NOT APPROVED BY THE FDA
I N F O R M AT I O N F O R O R D E R I N G
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T H E S E D R U G P R O D U C T S A R E N O T F D A A P P R O V E D
PRODUCT LIST
Atropine Sulfate Injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 01
Caffeine & Sodium Benzoate Injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 01
Indigo Carmine Injection (Indigotindisulfonate Sodium Injection, USP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 01
Manganese Sulfate Injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 02
Multitrace®-4 Concentrate (Trace Elements Injection 4, USP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 02
Multitrace®-4 Neonatal (Trace Elements Injection 4, USP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 02
Multitrace®-4 Pediatric (Trace Elements Injection 4, USP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 03
Multitrace®-5 Concentrate (Trace Elements Injection 5, USP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 03
Multitrace®-5 (Trace Elements Injection 5, USP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 03
Papaverine Hydrochloride Injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 04
Sterile Water for Injection, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 04
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T H E S E D R U G P R O D U C T S A R E N O T F D A A P P R O V E D
Atropine Sulfate Injection, USP
Pack NDC# Strength Size Shelf Pack
0517-0401-25 0.4 mg/mL 1 mL Single Dose Vial 25
0517-1010-25 1 mg/mL 1 mL Single Dose Vial 25
Preservative-free. Vial closure is not made with natural rubber latex.
Caffeine & Sodium Benzoate Injection, USP
Pack NDC# Strength Size Shelf Pack
0517-2502-10 250 mg/mL (125 mg/mL Caffeine) 2 mL Single Dose Vial 10
Preservative-free. Vial closure is not made with natural rubber latex.
Indigo Carmine Injection (Indigotindisulfonate Sodium Injection, USP)
Pack NDC# Strength Size Shelf Pack
0517-0375-05 0.8% Solution 5 mL ampule 5
Preservative-free. Ampule.
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To learn more or place an order, please call 1.800.645.1706 www.americanregent.com02
T H E S E D R U G P R O D U C T S A R E N O T F D A A P P R O V E D
Manganese Sulfate Injection, USP
Pack NDC# Strength Size Shelf Pack
0517-6410-25 0.1 mg/mL 10 mL Single Dose Vial 25
Preservative-free. Vial closure is not made with natural rubber latex.
Multitrace®-4 Neonatal (Trace Elements Injection 4, USP)
Pack NDC# Strength Size Shelf Pack
0517-6202-25 Neonatal 2 mL Single Dose Vial 25
Preservative-free. Vial closure is not made with natural rubber latex.
Multitrace®-4 Concentrate (Trace Elements Injection 4, USP)
Pack NDC# Strength Size Shelf Pack
0517-7201-25 Concentrate 1 mL Single Dose Vial 25
Preservative-free. Vial closure is not made with natural rubber latex.
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To learn more or place an order, please call 1.800.645.1706 www.americanregent.com 03
T H E S E D R U G P R O D U C T S A R E N O T F D A A P P R O V E D
Multitrace®-4 Pediatric (Trace Elements Injection 4, USP)
Pack NDC# Strength Size Shelf Pack
0517-9203-25 Pediatric 3 mL Single Dose Vial 25
Preservative-free. Vial closure is not made with natural rubber latex.
Multitrace®-5 Concentrate (Trace Elements Injection 5, USP)
Pack NDC# Strength Size Shelf Pack
0517-8201-25 Concentrate 1 mL Single Dose Vial* 25
0517-8210-25 Concentrate 10 mL Multiple Dose Vial** 25
*Preservative-free **Preserved with 0.9% Benzyl Alcohol.. Vial closure is not made with natural rubber latex.
Multitrace®-5 (Trace Elements Injection 5, USP)
Pack NDC# Strength Size Shelf Pack
0517-8510-25 – 10 mL Multiple Dose Vial 25
Preserved with 0.9% Benzyl Alcohol. Vial closure is not made with natural rubber latex.
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To learn more or place an order, please call 1.800.645.1706 www.americanregent.com04
T H E S E D R U G P R O D U C T S A R E N O T F D A A P P R O V E D
Papaverine Hydrochloride Injection, USP
Pack NDC# Strength Size Shelf Pack
0517-4002-25 30 mg/mL 2 mL Single Dose Vial 25
Preservative-free. Vial closure is not made with natural rubber latex.
Sterile Water for Injection, USP
Pack NDC# Strength Size Shelf Pack
0517-3005-25 - 5 mL Single Dose Vial 25
0517-3010-25 - 10 mL Single Dose Vial 25
0517-3020-25 - 20 mL Single Dose Vial 25
For Drug Diluent Use. Preservative-free. Vial closure is not made with natural rubber latex.
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To learn more or place an order, please call 1.800.645.1706 www.americanregent.com 05
T H E S E D R U G P R O D U C T S A R E N O T F D A A P P R O V E D
Pack NDC # Product Description Shelf Pack ABC/SAP Cardinal McKessonMorris & Dickson
0517-0401-25Atropine Sulfate Injection, USP 0.4 mg/mL; 1 mL Single Dose Vial
25 10036544 1467331 1730464 076695
0517-1010-25Atropine Sulfate Injection, USP 1 mg/mL; 1 mL Single Dose Vial
25 10036546 1467349 3210242 076323
0517-2502-10
Caffeine & Sodium Benzoate Injection, USP 250 mg/mL (125 mg/mL Caffeine) 2 mL Single Dose Vial
10 10037453 1260371 2756732 080119
0517-0375-05
Indigo Carmine Injection (Indigotindisulfonate Sodium Injection, USP) 0.8% Solution 5 mL ampule
5 10178911 5367552 3671385 981613
0517-6410-25Manganese Sulfate Injection, USP 0.1 mg/mL10 mL Single Dose Vial
25 10036348 1592310 1720200 080192
0517-7201-25Multitrace®-4 Concentrate (Trace Elements Injection 4, USP) 1 mL Single Dose Vial
25 10037412 1248996 2754760 076794
0517-6202-25Multitrace®-4 Neonatal (Trace Elements Injection 4, USP) 2 mL Single Dose Vial
25 10032455 2138253 2154896 076869
0517-9203-25Multitrace®-4 Pediatric (Trace Elements Injection 4, USP) 3 mL Single Dose Vial
25 10037406 1249028 2754505 076802
WHOLESALER ITEM NUMBERS
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To learn more or place an order, please call 1.800.645.1706 www.americanregent.com06
T H E S E D R U G P R O D U C T S A R E N O T F D A A P P R O V E D
Pack NDC # Product Description Shelf Pack ABC/SAP Cardinal McKessonMorris & Dickson
0517-8201-25Multitrace®-5 Concentrate (Trace Elements Injection 5, USP) 1 mL Single Dose Vial
25 10037779 1776061 3615994 656348
0517-8210-25Multitrace®-5 Concentrate (Trace Elements Injection 5, USP) 10 mL Multiple Dose Vial
25 10035565 1975010 3791324 076711
0517-8510-25Multitrace®-5 (Trace Elements Injection 5, USP) 10 mL Multiple Dose Vial
25 10038339 2072403 3615705 076547
0517-4002-25Papaverine Hydrochloride Injection, USP 30 mg/mL; 2 mL Single Dose Vial
25 10055219 3518289 2210334 508259
0517-3005-25Sterile Water for Injection, USP5 mL Single Dose Vial
25 10036166 1187046 2274942 656355
0517-3010-25Sterile Water for Injection, USP10 mL Single Dose Vial
25 10036167 1187095 2278729 079640
0517-3020-25Sterile Water for Injection, USP20 mL Single Dose Vial
25 10036170 1587336 1468768 076299
WHOLESALER ITEM NUMBERS
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To learn more or place an order, please call 1.800.645.1706 www.americanregent.com 07
T H E S E D R U G P R O D U C T S A R E N O T F D A A P P R O V E D
CONTACT US
Please refer to the contact information below for any assistance you may need.
• You are encouraged to report Adverse Drug Events (ADEs) to American Regent, Inc.
– T 1.800.734.9236 – E [email protected] – F 1.610.650.0170
• ADEs may also be reported to the FDA: – T 1.800.FDA.1088 – www.fda.gov/MedWatch
• Drug Information – T 1.888.354.4855 (9:00 am–5:00 pm Eastern Time, Monday–Friday) – E [email protected]
• For Urgent Drug Information outside of normal business hours, assistance is available at: – T 1.877.845.6371
• For Full Prescribing Information and SDS, please visit: www.americanregent.com
• To place an order: 1.800.645.1706 (8:30 am–6:00 pm, Monday–Thursday and Friday 8:30 am–5:00 pm Eastern Time)
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To learn more or place an order, please call 1.800.645.1706 www.americanregent.com08
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© 2020 American Regent, Inc. PP-AT-US-0017 5/2020
265 Broadhollow Road 4th Floor Melville, NY 11747 1.800.645.1706F 631.924.1731 E [email protected] www.americanregent.com
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