FDA.reportPublic FDA data

Bumetanide

Product NDC
0641-6008
11-digit product format
006416008
Labeler code
0641
Product ID
0641-6008_99d2fc38-7e1e-4209-aa57-089794eda8a6
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
0641-6008-01Bumetanide4 mL in 1 VIALINJECTION45
0641-6008-10Bumetanide10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6008-01ML - Milliliter0641-60086a162853-b94b-4a12-bf20-7dc639279e9512012-07-24
0641-6008-10ML - Milliliter0641-6008869a026c-d9f5-431b-a3aa-74c42ebf7a3312012-07-24

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
0641-6008BUMETANIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20240410_681b5e9d-e2c7-4f29-aaad-e06d4a528c11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282486bumetanide 0.25 MG/ML Injectable SolutionPSN681b5e9d-e2c7-4f29-aaad-e06d4a528c115
1727569bumetanide 1 MG in 4 ML InjectionPSN681b5e9d-e2c7-4f29-aaad-e06d4a528c115
17275694 ML bumetanide 0.25 MG/ML InjectionSCD681b5e9d-e2c7-4f29-aaad-e06d4a528c115
282486bumetanide 0.25 MG/ML Injectable SolutionSCD681b5e9d-e2c7-4f29-aaad-e06d4a528c115
1727569bumetanide 1 MG per 4 ML InjectionSY681b5e9d-e2c7-4f29-aaad-e06d4a528c115
1727569bumetanide 1 MG in 4 ML InjectionPSN9bd7a71e-0e78-dae7-e053-2995a90ad1103
17275694 ML bumetanide 0.25 MG/ML InjectionSCD9bd7a71e-0e78-dae7-e053-2995a90ad1103
1727569bumetanide 1 MG per 4 ML InjectionSY9bd7a71e-0e78-dae7-e053-2995a90ad1103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6008-01006416008014 mL in 1 VIAL4 mlHistorical
0641-6008-100064160081010 VIAL in 1 CARTON (0641-6008-10) / 4 mL in 1 VIAL (0641-6008-01) 10 vial2008-04-300000-00-00NoNoCurrent