Bumetanide

Product NDC
51672-4223
11-digit product format
516724223
Labeler code
51672
Product ID
51672-4223_4db68936-9d9c-1821-e063-6394a90a7f1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA213458
Marketing category
ANDA
Marketing start
2023-07-24
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
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
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
51672-4223-1Bumetanide100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4223-1EA - Each51672-4223a9421304-e018-44ab-b5b1-bd165390310712024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4223BUMETANIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, 1 package rows20240522_5c753aae-77b7-4add-8453-385a8f62d7db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197417bumetanide 0.5 MG Oral TabletPSN5c753aae-77b7-4add-8453-385a8f62d7db5
197418bumetanide 1 MG Oral TabletPSN5c753aae-77b7-4add-8453-385a8f62d7db5
197419bumetanide 2 MG Oral TabletPSN5c753aae-77b7-4add-8453-385a8f62d7db5
197417bumetanide 0.5 MG Oral TabletSCD5c753aae-77b7-4add-8453-385a8f62d7db5
197418bumetanide 1 MG Oral TabletSCD5c753aae-77b7-4add-8453-385a8f62d7db5
197419bumetanide 2 MG Oral TabletSCD5c753aae-77b7-4add-8453-385a8f62d7db5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-4223-151672422301100 TABLET in 1 BOTTLE (51672-4223-1) 100 tablet2023-07-24NoNoHistorical