FDA.reportPublic FDA data

Bumetanide

Product NDC
60687-535
11-digit product format
606870535
Labeler code
60687
Product ID
60687-535_21374d66-9881-6023-e063-6394a90a39d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
NDA018225
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-07-13
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
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
BUMETANIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0Y2S3XUQ5H
Rxcui197418, 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
60687-535-01Bumetanide100 in 1 BOX, UNIT-DOSETABLET1007
60687-535-11Bumetanide1 in 1 BLISTER PACKTABLET17
60687-535-65Bumetanide50 in 1 CARTONTABLET507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-535-01EA - Each60687-535a939233c-6598-4799-9b4b-33d2f82fb54c12020-07-13
60687-535-11EA - Each60687-535673f6c65-2ad9-4a71-803c-64aa1ef7277412020-07-13
60687-535-65EA - Each60687-535e286d036-6f3d-4045-b0d2-6d24004bb67512024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-535BUMETANIDE TABLET [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 3 package rows20240904_5e9633e4-151b-4f40-885e-8f364f6f2d18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197418bumetanide 1 MG Oral TabletPSN5e9633e4-151b-4f40-885e-8f364f6f2d187
197419bumetanide 2 MG Oral TabletPSN5e9633e4-151b-4f40-885e-8f364f6f2d187
197418bumetanide 1 MG Oral TabletSCD5e9633e4-151b-4f40-885e-8f364f6f2d187
197419bumetanide 2 MG Oral TabletSCD5e9633e4-151b-4f40-885e-8f364f6f2d187

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-535-0160687053501100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-535-01) > 1 TABLET in 1 BLISTER PACK (60687-535-11) 100 blister pack2020-03-200000-00-00NoNoCurrent
60687-535-11606870535111 in 1 BLISTER PACKHistorical
60687-535-656068705356550 BLISTER PACK in 1 CARTON (60687-535-65) / 1 TABLET in 1 BLISTER PACK (60687-535-11) 50 blister pack2024-09-01NoNoHistorical