FDA.reportPublic FDA data

Bumex

Product NDC
30698-631
11-digit product format
306980631
Labeler code
30698
Product ID
30698-631_3e4799b2-7621-c0b4-e063-6394a90a47b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Validus Pharmaceuticals LLC
Application
NDA018225
Marketing category
NDA
Marketing start
1983-02-28
Substance
BUMETANIDE
Active strength
1 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
Bumex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUMETANIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0Y2S3XUQ5H
Rxcui197417, 197418, 197419, 205488, 205489, 205490

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30698-631-012025-09-08C16284748780-1f386c649-b3c9-0266-e053-dadaa90a7c1aBumex
30698-631-012025-01-30C16284748780-1f386c649-b3c9-0266-e053-dadaa90a7c1aBumex
30698-631-012023-12-14C16284748780-1f386c649-b3c9-0266-e053-dadaa90a7c1aBumex
30698-631-012023-01-30C16284748780-1f386c649-b3c9-0266-e053-dadaa90a7c1aBumex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30698-631-01Bumex100 in 1 BOTTLETABLET1005
30698-631-05Bumex500 in 1 BOTTLETABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30698-631-01EA - Each30698-631afee74bb-848e-4e55-8b2a-3834dced940512018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30698-631BUMEX (BUMETANIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 2 package rows20231215_32dfbea3-eb2b-4070-8605-57ce3e6d5a2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197417bumetanide 0.5 MG Oral TabletPSN32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
197418bumetanide 1 MG Oral TabletPSN32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
197419bumetanide 2 MG Oral TabletPSN32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205488Bumex 0.5 MG Oral TabletPSN32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205489Bumex 1 MG Oral TabletPSN32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205490Bumex 2 MG Oral TabletPSN32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205488bumetanide 0.5 MG Oral Tablet [Bumex]SBD32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205489bumetanide 1 MG Oral Tablet [Bumex]SBD32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205490bumetanide 2 MG Oral Tablet [Bumex]SBD32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
197417bumetanide 0.5 MG Oral TabletSCD32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
197418bumetanide 1 MG Oral TabletSCD32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
197419bumetanide 2 MG Oral TabletSCD32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205488Bumex 0.5 MG Oral TabletSY32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205489Bumex 1 MG Oral TabletSY32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5
205490Bumex 2 MG Oral TabletSY32dfbea3-eb2b-4070-8605-57ce3e6d5a2f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30698-631-0130698063101100 TABLET in 1 BOTTLE (30698-631-01) 100 tablet1983-02-280000-00-00NoNoCurrent
30698-631-0530698063105500 TABLET in 1 BOTTLE (30698-631-05) 500 tablet2024-01-17NoNoCurrent