Bumetanide

Product NDC
42799-119
11-digit product format
427990119
Labeler code
42799
Product ID
42799-119_462dc93e-f284-3a48-e063-6394a90a7ce1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
NDA018225
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-10-15
Substance
BUMETANIDE
Active strength
.5 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
BUMETANIDE.5 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
42799-119-01Bumetanide100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-119-01EA - Each42799-11912ef3739-5969-4d05-9377-8364f7c19cfb12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BumetanideACTIVE INGREDIENT0Y2S3XUQ5HBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
BumetanideACTIVE MOIETY0Y2S3XUQ5HBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-119BUMETANIDE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.]4Current NDC, Legacy NDC, 1 package rows20190402_32c4372e-54ea-4fc8-b9f8-827fa4c8edd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197417bumetanide 0.5 MG Oral TabletPSN32c4372e-54ea-4fc8-b9f8-827fa4c8edd36
197418bumetanide 1 MG Oral TabletPSN32c4372e-54ea-4fc8-b9f8-827fa4c8edd36
197419bumetanide 2 MG Oral TabletPSN32c4372e-54ea-4fc8-b9f8-827fa4c8edd36
197417bumetanide 0.5 MG Oral TabletSCD32c4372e-54ea-4fc8-b9f8-827fa4c8edd36
197418bumetanide 1 MG Oral TabletSCD32c4372e-54ea-4fc8-b9f8-827fa4c8edd36
197419bumetanide 2 MG Oral TabletSCD32c4372e-54ea-4fc8-b9f8-827fa4c8edd36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42799-119-0142799011901100 TABLET in 1 BOTTLE (42799-119-01) 100 tablet2015-10-150000-00-00NoNoCurrent