NDC 0409-2344

DOBUTAMINE

Dobutamine

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

Product ID0409-2344_05ad3ad4-86b3-416d-9218-bd6b7f6efea1
NDC0409-2344
Product TypeHuman Prescription Drug
Proprietary NameDOBUTAMINE
Generic NameDobutamine
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2005-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA074086
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 Through2022-12-31

Packaging

NDC 0409-2344-88

10 VIAL, SINGLE-DOSE in 1 TRAY (0409-2344-88) > 20 mL in 1 VIAL, SINGLE-DOSE (0409-2344-68)
Marketing Start Date2005-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-2344-01 [00409234401]

DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA074086
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-08-03

NDC 0409-2344-62 [00409234462]

DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA074086
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-01-09

NDC 0409-2344-02 [00409234402]

DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA074086
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-06-29

NDC 0409-2344-88 [00409234488]

DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA074086
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-04-30

NDC 0409-2344-68 [00409234468]

DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA074086
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-11-02

Drug Details

Active Ingredients

IngredientStrength
DOBUTAMINE HYDROCHLORIDE12.5 mg/mL

OpenFDA Data

SPL SET ID:89becb0c-da60-4f43-0a98-29ff7a9eca58
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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