Bumetanide

Product NDC
63629-4968
11-digit product format
636294968
Labeler code
63629
Product ID
63629-4968_e3247459-31c2-48a5-959e-d3ec3d92be66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074700
Marketing category
ANDA
Marketing start
1996-11-21
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
1d3f2f0a-cce7-32fe-77bf-6ee61839e736Product name220171211

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4968-1Bumetanide30 in 1 BOTTLETABLET301014
63629-4968-2Bumetanide90 in 1 BOTTLETABLET901014
63629-4968-3Bumetanide28 in 1 BOTTLETABLET281014
63629-4968-4Bumetanide18 in 1 BOTTLETABLET181014
63629-4968-5Bumetanide60 in 1 BOTTLETABLET601014
63629-4968-6Bumetanide100 in 1 BOTTLETABLET1001014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUMETANIDEACTIVE INGREDIENT0Y2S3XUQ5HBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
BUMETANIDEACTIVE MOIETY0Y2S3XUQ5HBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UBUMETANIDE TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4968BUMETANIDE TABLET [BRYANT RANCH PREPACK]1014Current NDC, Legacy NDC, 6 package rows20240726_0fb6d547-9966-4352-8974-d02ea58e6445.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197418bumetanide 1 MG Oral TabletPSN0fb6d547-9966-4352-8974-d02ea58e64451014
197418bumetanide 1 MG Oral TabletSCD0fb6d547-9966-4352-8974-d02ea58e64451014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4968-16362949680130 TABLET in 1 BOTTLE (63629-4968-1) 30 tablet2013-04-020000-00-00NoNoCurrent
63629-4968-26362949680290 TABLET in 1 BOTTLE (63629-4968-2) 90 tablet2016-04-260000-00-00NoNoCurrent
63629-4968-36362949680328 TABLET in 1 BOTTLE (63629-4968-3) 28 tablet2022-04-290000-00-00NoNoCurrent
63629-4968-46362949680418 TABLET in 1 BOTTLE (63629-4968-4) 18 tablet2022-04-290000-00-00NoNoCurrent
63629-4968-56362949680560 TABLET in 1 BOTTLE (63629-4968-5) 60 tablet2022-04-290000-00-00NoNoCurrent
63629-4968-663629496806100 TABLET in 1 BOTTLE (63629-4968-6) 100 tablet2022-04-29NoNoHistorical