FDA.reportPublic FDA data

bumetanide

Product NDC
23155-901
11-digit product format
231550901
Labeler code
23155
Product ID
23155-901_ee0c44ac-10ca-4d9b-98f0-1342fc97dd39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA074225
Marketing category
ANDA
Marketing start
2024-06-28
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
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
23155-901-01bumetanide100 in 1 BOTTLETABLET1002
23155-901-05bumetanide500 in 1 BOTTLETABLET5002
23155-901-10bumetanide1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-901-01EA - Each23155-901fc49eaa0-2956-4b96-9052-d05553b6a63a12024-08-12
23155-901-05EA - Each23155-901837cc75b-bd02-4db2-889b-5d95f2ac9f4312024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-901BUMETANIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]1Current NDC, 3 package rows20240702_d4688d53-9baf-4cf0-b37f-47779bce7815.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197417bumetanide 0.5 MG Oral TabletPSNd4688d53-9baf-4cf0-b37f-47779bce78152
197418bumetanide 1 MG Oral TabletPSNd4688d53-9baf-4cf0-b37f-47779bce78152
197419bumetanide 2 MG Oral TabletPSNd4688d53-9baf-4cf0-b37f-47779bce78152
197417bumetanide 0.5 MG Oral TabletSCDd4688d53-9baf-4cf0-b37f-47779bce78152
197418bumetanide 1 MG Oral TabletSCDd4688d53-9baf-4cf0-b37f-47779bce78152
197419bumetanide 2 MG Oral TabletSCDd4688d53-9baf-4cf0-b37f-47779bce78152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-901-0123155090101100 TABLET in 1 BOTTLE (23155-901-01) 100 tablet2024-06-28NoNoCurrent
23155-901-0523155090105500 TABLET in 1 BOTTLE (23155-901-05) 500 tablet2024-06-28NoNoCurrent
23155-901-10231550901101000 TABLET in 1 BOTTLE (23155-901-10) 1000 tablet2024-06-28NoNoCurrent