Bumetanide

Product NDC
70518-4478
11-digit product format
705184478
Labeler code
70518
Product ID
70518-4478_3e9b97a1-21dc-4fbb-e063-6394a90afd8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213942
Marketing category
ANDA
Marketing start
2025-09-12
Substance
BUMETANIDE
Active strength
2 mg/1
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
70518-4478-07051844780090 TABLET in 1 BOTTLE, PLASTIC (70518-4478-0) 90 tablet2025-09-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Bumetanide - REMEDYREPACK INC.REMEDYREPACK INC.2025-09-12HUMAN PRESCRIPTION DRUG LABEL1