FDA.reportPublic FDA data

bumetanide

Product NDC
68382-527
11-digit product format
683820527
Labeler code
68382
Product ID
68382-527_58b3bb3b-6096-42fd-aebc-c856c3050071
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA202900
Marketing category
ANDA
Marketing start
2018-05-01
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
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
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
68382-527-01bumetanide100 in 1 BOTTLETABLET1005
68382-527-05bumetanide500 in 1 BOTTLETABLET5005
68382-527-06bumetanide30 in 1 BOTTLETABLET305
68382-527-10bumetanide1000 in 1 BOTTLETABLET10005
68382-527-16bumetanide90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-527-01EA - Each68382-5278a1a9dbb-9e5c-48e3-978e-00133c58e3cb12018-08-13
68382-527-05EA - Each68382-527d0618500-8e22-4f6f-8f25-44a0a2584c7712020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-527BUMETANIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5Current NDC, Legacy NDC, 5 package rows20231206_525138cd-832a-41d0-84b0-83921b12bd2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197419bumetanide 2 MG Oral TabletPSN8b5a38cc-1e76-4821-b286-31bad3bd69138
197419bumetanide 2 MG Oral TabletSCD8b5a38cc-1e76-4821-b286-31bad3bd69138
197417bumetanide 0.5 MG Oral TabletPSN525138cd-832a-41d0-84b0-83921b12bd2a5
197418bumetanide 1 MG Oral TabletPSN525138cd-832a-41d0-84b0-83921b12bd2a5
197419bumetanide 2 MG Oral TabletPSN525138cd-832a-41d0-84b0-83921b12bd2a5
197417bumetanide 0.5 MG Oral TabletSCD525138cd-832a-41d0-84b0-83921b12bd2a5
197418bumetanide 1 MG Oral TabletSCD525138cd-832a-41d0-84b0-83921b12bd2a5
197419bumetanide 2 MG Oral TabletSCD525138cd-832a-41d0-84b0-83921b12bd2a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-527-0168382052701100 TABLET in 1 BOTTLE (68382-527-01) 100 tablet2018-05-010000-00-00NoNoCurrent
68382-527-0568382052705500 TABLET in 1 BOTTLE (68382-527-05) 500 tablet2018-05-010000-00-00NoNoCurrent
68382-527-066838205270630 TABLET in 1 BOTTLE (68382-527-06) 30 tablet2018-05-010000-00-00NoNoCurrent
68382-527-10683820527101000 TABLET in 1 BOTTLE (68382-527-10) 1000 tablet2018-05-010000-00-00NoNoCurrent
68382-527-166838205271690 TABLET in 1 BOTTLE (68382-527-16) 90 tablet2018-05-010000-00-00NoNoCurrent