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 ID: 0409-2344_05ad3ad4-86b3-416d-9218-bd6b7f6efea1
• NDC: 0409-2344
• Product Type: Human Prescription Drug
• Proprietary Name: DOBUTAMINE
• Generic Name: Dobutamine
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2005-04-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074086
• Labeler Name: Hospira, 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: 2022-12-31

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 Date: 2005-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0409-2344-01 [00409234401]

DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA074086
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-08-03

NDC 0409-2344-62 [00409234462]

DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA074086
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-01-09

NDC 0409-2344-02 [00409234402]

DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA074086
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-06-29

NDC 0409-2344-88 [00409234488]

DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA074086
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-04-30

NDC 0409-2344-68 [00409234468]

DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA074086
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-11-02

Drug Details

Active Ingredients

Ingredient	Strength
DOBUTAMINE HYDROCHLORIDE	12.5 mg/mL

OpenFDA Data

• SPL SET ID: 89becb0c-da60-4f43-0a98-29ff7a9eca58
• Manufacturer:
  • Hospira, Inc.
• UNII:
  • 0WR771DJXV
• 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"

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