Bumetanide

Product NDC
0615-8616
11-digit product format
006158616
Labeler code
0615
Product ID
0615-8616_dba39aec-7927-4310-a6d4-ee8de8b7163f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA213942
Marketing category
ANDA
Marketing start
2025-01-16
Substance
BUMETANIDE
Active strength
2 mg/1
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
BUMETANIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0Y2S3XUQ5H
Rxcui197417, 197418, 197419

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
0615-8616-39Bumetanide30 in 1 BLISTER PACKTABLET304

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197417bumetanide 0.5 MG Oral TabletPSNfa4e5faf-c91a-457b-bd2b-14a9add51ac84
197418bumetanide 1 MG Oral TabletPSNfa4e5faf-c91a-457b-bd2b-14a9add51ac84
197419bumetanide 2 MG Oral TabletPSNfa4e5faf-c91a-457b-bd2b-14a9add51ac84
197417bumetanide 0.5 MG Oral TabletSCDfa4e5faf-c91a-457b-bd2b-14a9add51ac84
197418bumetanide 1 MG Oral TabletSCDfa4e5faf-c91a-457b-bd2b-14a9add51ac84
197419bumetanide 2 MG Oral TabletSCDfa4e5faf-c91a-457b-bd2b-14a9add51ac84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8616-390061586163930 TABLET in 1 BLISTER PACK (0615-8616-39) 30 tablet2026-01-15NoNoHistorical