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

vial label

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

carton label
DOBUTAMINE 
dobutamine injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62778-350
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOBUTAMINE HYDROCHLORIDE (UNII: 0WR771DJXV) (DOBUTAMINE - UNII:3S12J47372) DOBUTAMINE12.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM METABISULFITE (UNII: 4VON5FNS3C) .26 mg  in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62778-350-0210 in 1 CARTON05/03/202305/03/2023
1NDC: 62778-350-0120 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07427705/03/202305/03/2023
Labeler - Hikma Farmaceutica (452742943)
Registrant - Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 2/2024
 

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