FDA.reportPublic FDA data

Bumetanide

Product NDC
0641-6285
11-digit product format
006416285
Labeler code
0641
Product ID
0641-6285_cbf46236-4090-445f-ad19-fd9d767deecc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA079196
Marketing category
ANDA
Marketing start
2008-04-30
Substance
BUMETANIDE
Active strength
.25 mg/mL
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
BUMETANIDE.25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0Y2S3XUQ5H
Rxcui282486, 1727569

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
0641-6285-01Bumetanide10 mL in 1 VIALINJECTION107
0641-6285-10Bumetanide10 in 1 CARTONINJECTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6285-01ML - Milliliter0641-628515047615-ad2b-486a-a96c-f666ea447cf912025-05-14
0641-6285-10ML - Milliliter0641-6285a744da5d-e744-40aa-a6e1-360180f9174c12025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUMETANIDEACTIVE INGREDIENT0Y2S3XUQ5HBUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
BUMETANIDEACTIVE MOIETY0Y2S3XUQ5HBUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
AMMONIUM ACETATEINACTIVE INGREDIENTRRE756S6Q2BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHBUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RBUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6285BUMETANIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, 2 package rows20250406_b5a68154-8003-4b80-81e2-e926524fb72c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282486bumetanide 0.25 MG/ML Injectable SolutionPSNb5a68154-8003-4b80-81e2-e926524fb72c7
1727569bumetanide 1 MG in 4 ML InjectionPSNb5a68154-8003-4b80-81e2-e926524fb72c7
17275694 ML bumetanide 0.25 MG/ML InjectionSCDb5a68154-8003-4b80-81e2-e926524fb72c7
282486bumetanide 0.25 MG/ML Injectable SolutionSCDb5a68154-8003-4b80-81e2-e926524fb72c7
1727569bumetanide 1 MG per 4 ML InjectionSYb5a68154-8003-4b80-81e2-e926524fb72c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0641-6285-010064162850110 mL in 1 VIAL10 mlHistorical
0641-6285-100064162851010 VIAL in 1 CARTON (0641-6285-10) / 10 mL in 1 VIAL (0641-6285-01) 10 vial2008-04-30NoNoCurrent