FDA.reportPublic FDA data

Bumetanide

Product NDC
25021-321
11-digit product format
250210321
Labeler code
25021
Product ID
25021-321_befc1cf3-b71c-4228-bc42-3495b1d4b00d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA074441
Marketing category
ANDA
Marketing start
2024-06-01
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
25021-321-04Bumetanide4 mL in 1 VIALINJECTION, SOLUTION41
25021-321-04Bumetanide10 in 1 CARTONINJECTION, SOLUTION101
25021-321-10Bumetanide10 in 1 CARTONINJECTION, SOLUTION101
25021-321-10Bumetanide10 mL in 1 VIALINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-321-04ML - Milliliter25021-321a0a7392c-2d68-4e29-9a9b-ac329ac86fa312024-09-09
25021-321-10ML - Milliliter25021-3216a37208d-b682-495c-b159-c27be3a7c1da12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-321BUMETANIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 4 package rows20240601_c38a404d-a919-4a2c-9fbb-d0655dee9516.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282486bumetanide 0.25 MG/ML Injectable SolutionPSNc38a404d-a919-4a2c-9fbb-d0655dee95161
1727569bumetanide 1 MG in 4 ML InjectionPSNc38a404d-a919-4a2c-9fbb-d0655dee95161
17275694 ML bumetanide 0.25 MG/ML InjectionSCDc38a404d-a919-4a2c-9fbb-d0655dee95161
282486bumetanide 0.25 MG/ML Injectable SolutionSCDc38a404d-a919-4a2c-9fbb-d0655dee95161
1727569bumetanide 1 MG per 4 ML InjectionSYc38a404d-a919-4a2c-9fbb-d0655dee95161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-321-042502103210410 VIAL in 1 CARTON (25021-321-04) / 4 mL in 1 VIAL10 vial2024-06-01NoNoCurrent
25021-321-102502103211010 VIAL in 1 CARTON (25021-321-10) / 10 mL in 1 VIAL10 vial2024-06-01NoNoCurrent