Bumetanide

Product NDC
76282-798
11-digit product format
762820798
Labeler code
76282
Product ID
76282-798_04a4ac27-f6b7-4a88-899b-93a5a21ddb6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA212931
Marketing category
ANDA
Marketing start
2025-03-01
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
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
BUMETANIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0Y2S3XUQ5H
Rxcui197417, 197418, 197419

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
76282-798-01Bumetanide100 in 1 BOTTLETABLET1002
76282-798-05Bumetanide500 in 1 BOTTLETABLET5002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197417bumetanide 0.5 MG Oral TabletPSN06745425-e7e7-4413-b9ff-22b121f0ea9a2
197418bumetanide 1 MG Oral TabletPSN06745425-e7e7-4413-b9ff-22b121f0ea9a2
197419bumetanide 2 MG Oral TabletPSN06745425-e7e7-4413-b9ff-22b121f0ea9a2
197417bumetanide 0.5 MG Oral TabletSCD06745425-e7e7-4413-b9ff-22b121f0ea9a2
197418bumetanide 1 MG Oral TabletSCD06745425-e7e7-4413-b9ff-22b121f0ea9a2
197419bumetanide 2 MG Oral TabletSCD06745425-e7e7-4413-b9ff-22b121f0ea9a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76282-798-0176282079801100 TABLET in 1 BOTTLE (76282-798-01) 100 tablet2025-03-01NoNoCurrent
76282-798-0576282079805500 TABLET in 1 BOTTLE (76282-798-05) 500 tablet2025-03-01NoNoCurrent