NDC 0409-2025

DOBUTAMINE

Dobutamine

DOBUTAMINE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Dobutamine Hydrochloride.

Product ID0409-2025_43404ce8-1a3b-4019-ae84-e4b350a7401b
NDC0409-2025
Product TypeHuman Prescription Drug
Proprietary NameDOBUTAMINE
Generic NameDobutamine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2005-11-17
Marketing CategoryANDA / ANDA
Application NumberANDA074292
Labeler NameHospira, Inc.
Substance NameDOBUTAMINE HYDROCHLORIDE
Active Ingredient Strength13 mg/mL
Pharm ClassesAdrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0409-2025-54

10 CARTON in 1 PACKAGE (0409-2025-54) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-2025-64) > 40 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2005-11-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-2025-54 [00409202554]

DOBUTAMINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074292
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-11-17
Marketing End Date2017-05-01

NDC 0409-2025-20 [00409202520]

DOBUTAMINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074292
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-02-23

NDC 0409-2025-64 [00409202564]

DOBUTAMINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074292
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-15

NDC 0409-2025-60 [00409202560]

DOBUTAMINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA074292
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-05-15

Drug Details

Active Ingredients

IngredientStrength
DOBUTAMINE HYDROCHLORIDE12.5 mg/mL

OpenFDA Data

SPL SET ID:cb842dc2-fb15-48f9-e4b1-ea4280db0199
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1812170
  • 1812168
  • Pharmacological Class

    • Adrenergic beta-Agonists [MoA]
    • beta-Adrenergic Agonist [EPC]

    NDC Crossover Matching brand name "DOBUTAMINE" or generic name "Dobutamine"

    NDCBrand NameGeneric Name
    0409-2025DOBUTAMINEDOBUTAMINE
    0409-2344DOBUTAMINEDOBUTAMINE
    14335-171DobutamineDobutamine
    14335-172DobutamineDobutamine
    51662-1330DOBUTAMINEDOBUTAMINE
    51662-1337DOBUTAMINEDOBUTAMINE
    52584-048DobutamineDobutamine Hydrochloride Injection

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.