NDC 51662-1337

DOBUTAMINE

Dobutamine

DOBUTAMINE is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Hf Acquisition Co Llc, Dba Healthfirst. The primary component is Dobutamine Hydrochloride.

Product ID51662-1337_7b9ea626-7073-2e77-e053-2a91aa0a9215
NDC51662-1337
Product TypeHuman Prescription Drug
Proprietary NameDOBUTAMINE
Generic NameDobutamine
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-11-26
Marketing CategoryANDA / ANDA
Application NumberANDA074086
Labeler NameHF Acquisition Co LLC, DBA HealthFirst
Substance NameDOBUTAMINE HYDROCHLORIDE
Active Ingredient Strength13 mg/mL
Pharm ClassesAdrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 51662-1337-1

20 mL in 1 VIAL, SINGLE-DOSE (51662-1337-1)
Marketing Start Date2018-11-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51662-1337-1 [51662133701]

DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA074086
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-26
Inactivation Date2020-01-31
Reactivation Date2020-02-07

Drug Details

Active Ingredients

IngredientStrength
DOBUTAMINE HYDROCHLORIDE12.5 mg/mL

OpenFDA Data

SPL SET ID:7b9ea626-7072-2e77-e053-2a91aa0a9215
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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
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