FDA.reportPublic FDA data

Bumetanide

Product NDC
72205-101
11-digit product format
722050101
Labeler code
72205
Product ID
72205-101_387edfd4-be85-41cd-8a6d-14e6a022b5a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA215364
Marketing category
ANDA
Marketing start
2022-08-06
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
72205-101-01Bumetanide4 mL in 1 VIALINJECTION41
72205-101-07Bumetanide10 in 1 CARTONINJECTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-101BUMETANIDE INJECTION [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, Legacy NDC, 2 package rows20220811_387edfd4-be85-41cd-8a6d-14e6a022b5a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1727569bumetanide 1 MG in 4 ML InjectionPSN43ab2dd6-39ba-4a53-aa84-d7975038ef43100
17275694 ML bumetanide 0.25 MG/ML InjectionSCD43ab2dd6-39ba-4a53-aa84-d7975038ef43100
1727569bumetanide 1 MG per 4 ML InjectionSY43ab2dd6-39ba-4a53-aa84-d7975038ef43100
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
282486bumetanide 0.25 MG/ML Injectable SolutionPSN387edfd4-be85-41cd-8a6d-14e6a022b5a91
1727569bumetanide 1 MG in 4 ML InjectionPSN387edfd4-be85-41cd-8a6d-14e6a022b5a91
17275694 ML bumetanide 0.25 MG/ML InjectionSCD387edfd4-be85-41cd-8a6d-14e6a022b5a91
282486bumetanide 0.25 MG/ML Injectable SolutionSCD387edfd4-be85-41cd-8a6d-14e6a022b5a91
1727569bumetanide 1 MG per 4 ML InjectionSY387edfd4-be85-41cd-8a6d-14e6a022b5a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72205-101-01722050101014 mL in 1 VIAL4 mlHistorical
72205-101-077220501010710 VIAL in 1 CARTON (72205-101-07) / 4 mL in 1 VIAL (72205-101-01) 10 vial2022-08-060000-00-00NoNoCurrent