Bumetanide

Product NDC
55154-1527
11-digit product format
551541527
Labeler code
55154
Product ID
55154-1527_5b9e8d84-41f6-4f90-a714-3b0703cfbba5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA215364
Marketing category
ANDA
Marketing start
2024-10-21
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bumetanide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUMETANIDE.25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0Y2S3XUQ5H
Rxcui1727569

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
55154-1527-5Bumetanide4 mL in 1 VIALINJECTION43
55154-1527-5Bumetanide5 in 1 BAGINJECTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-1527BUMETANIDE INJECTION [CARDINAL HEALTH 107, LLC]1Current NDC, 2 package rows20241023_68f18d36-ffc2-4481-9286-914cfcf573a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1727569bumetanide 1 MG in 4 ML InjectionPSN68f18d36-ffc2-4481-9286-914cfcf573a03
17275694 ML bumetanide 0.25 MG/ML InjectionSCD68f18d36-ffc2-4481-9286-914cfcf573a03
1727569bumetanide 1 MG per 4 ML InjectionSY68f18d36-ffc2-4481-9286-914cfcf573a03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-1527-5551541527055 VIAL in 1 BAG (55154-1527-5) / 4 mL in 1 VIAL5 vial2024-10-21NoNoCurrent