bumetanide

Product NDC
71335-1692
11-digit product format
713351692
Labeler code
71335
Product ID
71335-1692_3bd5380a-6de4-47fa-92b1-9c3d3874a1ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202900
Marketing category
ANDA
Marketing start
2018-05-01
Substance
BUMETANIDE
Active strength
1 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

openFDA Listing Details

Product ID
71335-1692_3bd5380a-6de4-47fa-92b1-9c3d3874a1ee
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
bumetanide
Generic name
bumetanide
Dosage form
TABLET
Route
ORAL
Marketing start
2018-05-01
Marketing category
ANDA
Application number
ANDA202900
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE]; Loop Diuretic [EPC]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
BUMETANIDE1 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii0Y2S3XUQ5H
Rxcui197418
Spl Set Ida60bfe5f-d0d6-4d15-a3de-32dc68e41af3
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0Y2S3XUQ5HBUMETANIDE28395-03-1BUMETANIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1692-17133516920130 TABLET in 1 BOTTLE (71335-1692-1) 30 tablet2020-08-170000-00-00NoNoCurrent
71335-1692-27133516920290 TABLET in 1 BOTTLE (71335-1692-2) 90 tablet2021-12-290000-00-00NoNoCurrent
71335-1692-37133516920328 TABLET in 1 BOTTLE (71335-1692-3) 28 tablet2021-12-290000-00-00NoNoCurrent
71335-1692-47133516920418 TABLET in 1 BOTTLE (71335-1692-4) 18 tablet2021-12-290000-00-00NoNoCurrent
71335-1692-57133516920560 TABLET in 1 BOTTLE (71335-1692-5) 60 tablet2021-12-290000-00-00NoNoCurrent
71335-1692-671335169206100 TABLET in 1 BOTTLE (71335-1692-6) 100 tablet2021-12-29NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Bumetanide Tablets, USP Rx onlyBryant Ranch Prepack2024-05-23HUMAN PRESCRIPTION DRUG LABEL4