NDC 52584-048

Dobutamine

Dobutamine Hydrochloride Injection

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

• Product ID: 52584-048_f1d5ca3f-f994-4a94-8d7e-de4f412db156
• NDC: 52584-048
• Product Type: Human Prescription Drug
• Proprietary Name: Dobutamine
• Generic Name: Dobutamine Hydrochloride Injection
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-11-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074292
• Labeler Name: General Injectables and Vaccines, Inc.
• Substance Name: DOBUTAMINE HYDROCHLORIDE
• Active Ingredient Strength: 13 mg/mL
• Pharm Classes: Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52584-048-20

1 VIAL, SINGLE-DOSE in 1 BAG (52584-048-20) > 20 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2014-11-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52584-048-20 [52584004820]

Dobutamine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074292
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-11-10

Drug Details

Active Ingredients

Ingredient	Strength
DOBUTAMINE HYDROCHLORIDE	12.5 mg/mL

OpenFDA Data

• SPL SET ID: e0c86f73-38ec-44ad-934b-f48777c41c55
• Manufacturer:
  • General Injectables and Vaccines, Inc.
• UNII:
  • 0WR771DJXV
• RxNorm Concept Unique ID - RxCUI:
  • 1812168

Pharmacological Class

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

NDC Crossover Matching brand name "Dobutamine" or generic name "Dobutamine Hydrochloride Injection"

NDC	Brand Name	Generic Name
0409-2025	DOBUTAMINE	DOBUTAMINE
0409-2344	DOBUTAMINE	DOBUTAMINE
14335-171	Dobutamine	Dobutamine
14335-172	Dobutamine	Dobutamine
51662-1330	DOBUTAMINE	DOBUTAMINE
51662-1337	DOBUTAMINE	DOBUTAMINE
52584-048	Dobutamine	Dobutamine Hydrochloride Injection