FDA.reportPublic FDA data

Bumetanide

Product NDC
68083-496
11-digit product format
680830496
Labeler code
68083
Product ID
68083-496_d9e3877d-de1a-4047-9866-413958c4cca0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA216434
Marketing category
ANDA
Marketing start
2022-05-26
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
68083-496-01Bumetanide4 mL in 1 VIAL, SINGLE-DOSEINJECTION44
68083-496-10Bumetanide10 in 1 CARTONINJECTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-496BUMETANIDE INJECTION [GLAND PHARMA LIMITED]4Current NDC, Legacy NDC, 2 package rows20220603_4d1ed6b2-c410-4f52-9b8a-aa256c37089e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282486bumetanide 0.25 MG/ML Injectable SolutionPSN4d1ed6b2-c410-4f52-9b8a-aa256c37089e4
1727569bumetanide 1 MG in 4 ML InjectionPSN4d1ed6b2-c410-4f52-9b8a-aa256c37089e4
17275694 ML bumetanide 0.25 MG/ML InjectionSCD4d1ed6b2-c410-4f52-9b8a-aa256c37089e4
282486bumetanide 0.25 MG/ML Injectable SolutionSCD4d1ed6b2-c410-4f52-9b8a-aa256c37089e4
1727569bumetanide 1 MG per 4 ML InjectionSY4d1ed6b2-c410-4f52-9b8a-aa256c37089e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-496-01680830496014 mL in 1 VIAL, SINGLE-DOSE4 mlHistorical
68083-496-106808304961010 VIAL, SINGLE-DOSE in 1 CARTON (68083-496-10) / 4 mL in 1 VIAL, SINGLE-DOSE (68083-496-01) 2022-05-260000-00-00NoNoCurrent