Bumetanide

Product NDC
0904-7016
11-digit product format
009047016
Labeler code
0904
Product ID
0904-7016_f1163b02-1c88-49ab-a34a-7646b61bb50e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA209724
Marketing category
ANDA
Marketing start
2017-10-18
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
0904-7016-04Bumetanide1 in 1 BLISTER PACKTABLET16
0904-7016-04Bumetanide30 in 1 CARTONTABLET306
0904-7016-06Bumetanide50 in 1 CARTONTABLET506
0904-7016-06Bumetanide1 in 1 BLISTER PACKTABLET16
0904-7016-61Bumetanide1 in 1 BLISTER PACKTABLET16
0904-7016-61Bumetanide100 in 1 CARTONTABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7016-04EA - Each0904-70168e30d4b0-ea35-421e-bcd0-5a0f8aebe9df12020-04-20
0904-7016-06EA - Each0904-701652cd1b11-0d62-4cc5-a5da-30b3dddc18ba12021-01-08
0904-7016-61EA - Each0904-701605af248f-b3e1-4e5a-bb8b-abff5111435012021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7016BUMETANIDE TABLET [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 6 package rows20250110_a29cf117-00d0-4948-b646-013c8791ea39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197418bumetanide 1 MG Oral TabletPSN9bd4fcd3-3020-41f2-b112-023b5db4487d6
197418bumetanide 1 MG Oral TabletPSNa29cf117-00d0-4948-b646-013c8791ea396
197418bumetanide 1 MG Oral TabletSCD9bd4fcd3-3020-41f2-b112-023b5db4487d6
197418bumetanide 1 MG Oral TabletSCDa29cf117-00d0-4948-b646-013c8791ea396

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7016-040090470160430 BLISTER PACK in 1 CARTON (0904-7016-04) / 1 TABLET in 1 BLISTER PACK30 blister pack2017-10-180000-00-00NoNoCurrent
0904-7016-060090470160650 BLISTER PACK in 1 CARTON (0904-7016-06) / 1 TABLET in 1 BLISTER PACK50 blister pack2017-10-180000-00-00NoNoCurrent
0904-7016-6100904701661100 BLISTER PACK in 1 CARTON (0904-7016-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2017-10-180000-00-00NoNoCurrent