Bumetanide

Product NDC
67184-0593
11-digit product format
671840593
Labeler code
67184
Product ID
67184-0593_b392cf53-2b1f-46b5-86dc-c0df49f16730
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Qilu Pharmaceutical Co., Ltd.
Application
ANDA219116
Marketing category
ANDA
Marketing start
2024-09-19
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
67184-0593-1Bumetanide4 mL in 1 VIALINJECTION43
67184-0593-2Bumetanide10 in 1 CARTONINJECTION103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282486bumetanide 0.25 MG/ML Injectable SolutionPSNef5fe12a-f8ee-4ba7-932b-51bbaccf65753
1727569bumetanide 1 MG in 4 ML InjectionPSNef5fe12a-f8ee-4ba7-932b-51bbaccf65753
17275694 ML bumetanide 0.25 MG/ML InjectionSCDef5fe12a-f8ee-4ba7-932b-51bbaccf65753
282486bumetanide 0.25 MG/ML Injectable SolutionSCDef5fe12a-f8ee-4ba7-932b-51bbaccf65753
1727569bumetanide 1 MG per 4 ML InjectionSYef5fe12a-f8ee-4ba7-932b-51bbaccf65753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67184-0593-1671840593014 mL in 1 VIAL4 mlHistorical
67184-0593-26718405930210 VIAL in 1 CARTON (67184-0593-2) / 4 mL in 1 VIAL (67184-0593-1) 10 vial2024-09-19NoNoCurrent