FDA.reportPublic FDA data

BUMETANIDE

Product NDC
70748-323
11-digit product format
707480323
Labeler code
70748
Product ID
70748-323_39d376d9-2fab-40d3-8592-668c5083a0c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA217153
Marketing category
ANDA
Marketing start
2024-11-11
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70748-323-10BUMETANIDE4 mL in 1 VIALINJECTION46
70748-323-10BUMETANIDE10 in 1 CARTONINJECTION106
70748-323-11BUMETANIDE10 in 1 CARTONINJECTION106
70748-323-11BUMETANIDE10 mL in 1 VIALINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70748-323-10ML - Milliliter70748-323a37fae7c-f096-4aee-aeab-af8850daad7912024-12-10
70748-323-11ML - Milliliter70748-323e583559f-8ec0-4195-8506-e85308b5334212024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70748-323BUMETANIDE INJECTION [LUPIN PHARMACEUTICALS, INC.]5Current NDC, 4 package rows20250418_2c71a17e-ed76-4545-b23e-9f4997b13c2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282486bumetanide 0.25 MG/ML Injectable SolutionPSN2c71a17e-ed76-4545-b23e-9f4997b13c2f6
1727569bumetanide 1 MG in 4 ML InjectionPSN2c71a17e-ed76-4545-b23e-9f4997b13c2f6
17275694 ML bumetanide 0.25 MG/ML InjectionSCD2c71a17e-ed76-4545-b23e-9f4997b13c2f6
282486bumetanide 0.25 MG/ML Injectable SolutionSCD2c71a17e-ed76-4545-b23e-9f4997b13c2f6
1727569bumetanide 1 MG per 4 ML InjectionSY2c71a17e-ed76-4545-b23e-9f4997b13c2f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70748-323-107074803231010 VIAL in 1 CARTON (70748-323-10) / 4 mL in 1 VIAL10 vial2024-11-11NoNoHistorical
70748-323-117074803231110 VIAL in 1 CARTON (70748-323-11) / 10 mL in 1 VIAL10 vial2024-11-11NoNoHistorical