Bumetanide

Product NDC
0641-6284
11-digit product format
006416284
Labeler code
0641
Product ID
0641-6284_cbf46236-4090-445f-ad19-fd9d767deecc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA079196
Marketing category
ANDA
Marketing start
2008-04-30
Substance
BUMETANIDE
Active strength
.25 mg/mL
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0Y2S3XUQ5HBUMETANIDE28395-03-1BUMETANIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0641-6284-100064162841010 VIAL in 1 CARTON (0641-6284-10) / 4 mL in 1 VIAL (0641-6284-01) 10 vial2008-04-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Bumetanide Injection, USP Rx ONLY NOVAPLUS®Hikma Pharmaceuticals USA Inc.2025-04-03HUMAN PRESCRIPTION DRUG LABEL7