DOBUTamine Injection USP Rx ONLY

Dobutamine by

Drug Labeling and Warnings

Dobutamine by is a Prescription medication manufactured, distributed, or labeled by Hikma Farmaceutica, Hikma Pharmaceuticals USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOBUTAMINE- dobutamine injection, solution 
Hikma Farmaceutica

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DOBUTamine Injection USP
Rx ONLY

ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-332-1088 or www.fda.gov/medwatch.

"1-800-FDA-1088"

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 dilution
20 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 dilution
10 x 20 mL Single-Dose Vials

DOBUTAMINE 
dobutamine injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 62778-350
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOBUTAMINE HYDROCHLORIDE (UNII: 0WR771DJXV) (DOBUTAMINE - UNII:3S12J47372)	DOBUTAMINE	12.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	.26 mg  in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62778-350-02	10 in 1 CARTON	05/03/2023	05/03/2023
1	NDC: 62778-350-01	20 mL in 1 VIAL; Type 0: Not a Combination Product

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

Labeler - Hikma Farmaceutica (452742943)

Registrant - Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 2/2024

Document Id: f38d180a-a6ba-4c42-9078-d2d00bf99e1a

34391-3

Set id: 1b75c31c-f667-4f5f-b6cc-b2e881a90b18

Version: 3

Effective Time: 20240209