FDA.reportPublic FDA data

Bumetanide

Product NDC
50090-7876
11-digit product format
500907876
Labeler code
50090
Product ID
50090-7876_3f0a567c-3d3a-46a9-9864-04eea0dd46ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA212931
Marketing category
ANDA
Marketing start
2025-03-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bumetanide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUMETANIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0Y2S3XUQ5H
Rxcui197419

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
50090-7876-0Bumetanide90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7876-0EA - Each50090-78767e7c356f-c91e-4d43-9ee3-41b684dd957412026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197419bumetanide 2 MG Oral TabletPSNb338ae20-fc07-4ec5-9e68-be636f75ce1a1
197419bumetanide 2 MG Oral TabletSCDb338ae20-fc07-4ec5-9e68-be636f75ce1a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7876-05009078760090 TABLET in 1 BOTTLE (50090-7876-0) 90 tablet2026-02-02NoNoHistorical