Dobutamine

Product NDC
0143-9141
11-digit product format
001439141
Labeler code
0143
Product ID
0143-9141_b0a40444-634c-4eb0-a861-fe9e21e02552
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dobutamine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA074277
Marketing category
ANDA
Marketing start
2023-05-03
Substance
DOBUTAMINE HYDROCHLORIDE
Active strength
12.5 mg/mL
Pharmacologic classes
Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0WR771DJXVDOBUTAMINE HYDROCHLORIDE49745-95-1DOBUTAMINE HYDROCHLORIDE
3S12J47372DOBUTAMINE34368-04-2Dobutamine

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9141-100014391411010 VIAL in 1 CARTON (0143-9141-10) / 20 mL in 1 VIAL10 vial2023-05-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DOBUTamine Injection USP Rx ONLYHikma Pharmaceuticals USA Inc.2024-07-02HUMAN PRESCRIPTION DRUG LABEL6