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CATALOG OF PRODUCTS NOT APPROVED BY THE FDA INFORMATION FOR ORDERING

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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

  • 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

  • To learn more or place an order, please call 1.800.645.1706 www.americanregent.com 01

    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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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

  • 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)

  • To learn more or place an order, please call 1.800.645.1706 www.americanregent.com08

  • © 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

    mailto:inquiry%40americanregent.com?subject=http://www.americanregent.com