Bumetanide

Product NDC
70518-4385
11-digit product format
705184385
Labeler code
70518
Product ID
70518-4385_396ba025-0ad2-40dc-e063-6294a90a7d6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213942
Marketing category
ANDA
Marketing start
2025-07-06
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
70518-4385-0Bumetanide90 in 1 BOTTLE, PLASTICTABLET902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197418bumetanide 1 MG Oral TabletPSNde008936-e8a3-4e65-bb6a-d925b68a5f502
197418bumetanide 1 MG Oral TabletSCDde008936-e8a3-4e65-bb6a-d925b68a5f502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4385-07051843850090 TABLET in 1 BOTTLE, PLASTIC (70518-4385-0) 90 tablet2025-07-06NoNoHistorical