Dobutamine (Page 3 of 3)

HOW SUPPLIED

Dobutamine Injection USP, 20 mL single dose vial contains dobutamine hydrochloride, equivalent to 250 mg dobutamine per 20 mL; ten vials per carton. NDC 0143-9141-10.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured by:

HIKMA FARMACÊUTICA (PORTUGAL), S.A.

Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL

Distributed by:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

September 2022 PIN612-WES/1

PRINCIPAL DISPLAY PANEL

NDC 0143-9141 -01 Rx only

DOBUTamine Injection, USP
250 mg per 20 mL (12.5 mg/mL)
For Intravenous Use ONLY
Must be diluted prior to use
Use within 24 hours after dilution20 mL Single-Dose Vial

NDC 0143-9141 -10 Rx only

DOBUTamine Injection, USP
250 mg per 20 mL (12.5 mg/mL)
For Intravenous Use ONLY
Must be diluted prior to use
Use within 24 hours after dilution10 x 20 mL Single-Dose Vials

SERIALIZATION IMAGE

DOBUTAMINE dobutamine injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9141 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOBUTAMINE HYDROCHLORIDE (DOBUTAMINE) DOBUTAMINE 12.5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM METABISULFITE .26 mg in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0143-9141-10 10 VIAL in 1 CARTON contains a VIAL 1 20 mL in 1 VIAL This package is contained within the CARTON (0143-9141-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074277 05/03/2023

Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Registrant — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 05/2023 Hikma Pharmaceuticals USA Inc.