dobutamine

Generic: dobutamine

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dobutamine
Generic Name dobutamine
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dobutamine hydrochloride 12.5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9141
Product ID 0143-9141_b0a40444-634c-4eb0-a861-fe9e21e02552
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074277
Listing Expiration 2026-12-31
Marketing Start 2023-05-03

Pharmacologic Class

Classes
adrenergic beta-agonists [moa] beta-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439141
Hyphenated Format 0143-9141

Supplemental Identifiers

RxCUI
1812168
UNII
0WR771DJXV

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dobutamine (source: ndc)
Generic Name dobutamine (source: ndc)
Application Number ANDA074277 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0143-9141-10) / 20 mL in 1 VIAL
source: ndc

Packages (1)

0143-9141-10 10 VIAL in 1 CARTON (0143-9141-10) / 20 mL in 1 VIAL

Ingredients (1)

dobutamine hydrochloride (12.5 mg/mL)

Linked Drug Pages (1)

Dobutamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b0a40444-634c-4eb0-a861-fe9e21e02552", "openfda": {"unii": ["0WR771DJXV"], "rxcui": ["1812168"], "spl_set_id": ["74ba9408-17d3-48ac-be0b-a4fee9e7a1a5"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0143-9141-10)  / 20 mL in 1 VIAL", "package_ndc": "0143-9141-10", "marketing_start_date": "20230503"}], "brand_name": "Dobutamine", "product_id": "0143-9141_b0a40444-634c-4eb0-a861-fe9e21e02552", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Adrenergic beta-Agonists [MoA]", "beta-Adrenergic Agonist [EPC]"], "product_ndc": "0143-9141", "generic_name": "Dobutamine", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dobutamine", "active_ingredients": [{"name": "DOBUTAMINE HYDROCHLORIDE", "strength": "12.5 mg/mL"}], "application_number": "ANDA074277", "marketing_category": "ANDA", "marketing_start_date": "20230503", "listing_expiration_date": "20261231"}