FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
bumetanide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUMETANIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0Y2S3XUQ5H
Rxcui197418

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d3f2f0a-cce7-32fe-77bf-6ee61839e736Product name920260113
601d9750-f415-d9d9-619c-0a87b4d3f237Product name320250331
1d3f2f0a-cce7-32fe-77bf-6ee61839e736Product name220171211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1692-1bumetanide30 in 1 BOTTLETABLET304
71335-1692-2bumetanide90 in 1 BOTTLETABLET904
71335-1692-3bumetanide28 in 1 BOTTLETABLET284
71335-1692-4bumetanide18 in 1 BOTTLETABLET184
71335-1692-5bumetanide60 in 1 BOTTLETABLET604
71335-1692-6bumetanide100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1692BUMETANIDE TABLET [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 6 package rows20240524_a60bfe5f-d0d6-4d15-a3de-32dc68e41af3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197418bumetanide 1 MG Oral TabletPSNa60bfe5f-d0d6-4d15-a3de-32dc68e41af34
197418bumetanide 1 MG Oral TabletSCDa60bfe5f-d0d6-4d15-a3de-32dc68e41af34

Packages#

Package NDC, 11-digit format, Description table
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