FDA.reportPublic FDA data

Bumetanide

Product NDC
43353-288
11-digit product format
433530288
Labeler code
43353
Product ID
43353-288_b1b7dc90-3e5c-48cf-8a65-446c52e79d53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA074700
Marketing category
ANDA
Marketing start
1996-11-21
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
43353-288-09Bumetanide9000 in 1 BOTTLETABLET90002
43353-288-74Bumetanide9000 in 1 BOTTLETABLET90002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-288-09EA - Each43353-288d4d60065-ec00-4791-a2eb-11ef611ac95b12017-11-06
43353-288-74EA - Each43353-288e1cfc1a0-362a-4395-b5ec-0ebf59e06f3412019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-288BUMETANIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 2 package rows20191002_7e47e7b1-d28a-4e12-882f-cf193b7f2697.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197418bumetanide 1 MG Oral TabletPSN7e47e7b1-d28a-4e12-882f-cf193b7f26972
197418bumetanide 1 MG Oral TabletSCD7e47e7b1-d28a-4e12-882f-cf193b7f26972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-288-09433530288099000 TABLET in 1 BOTTLE (43353-288-09) 9000 tablet2017-03-100000-00-00NoNoCurrent
43353-288-74433530288749000 TABLET in 1 BOTTLE (43353-288-74) 9000 tablet2019-06-262021-12-24NoNoCurrent