FDA.reportPublic FDA data

Bumetanide

Product NDC
69238-1491
11-digit product format
692381491
Labeler code
69238
Product ID
69238-1491_d1961e90-3fcc-4b72-b207-6c9de6d66557
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bumetanide
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA209724
Marketing category
ANDA
Marketing start
2017-10-18
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
69238-1491-1Bumetanide100 in 1 BOTTLETABLET1009
69238-1491-5Bumetanide500 in 1 BOTTLETABLET5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1491-1EA - Each69238-1491e1ebf74d-b711-4811-98ae-344f3fcfb00212017-12-14
69238-1491-5EA - Each69238-14912861f5e8-6868-4bc5-b191-7f54611f3f3212017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1491BUMETANIDE TABLET [AMNEAL PHARMACEUTICALS NY LLC]9Current NDC, Legacy NDC, 2 package rows20231230_9188ab17-8539-48a5-905f-ad35ab5a0b93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197417bumetanide 0.5 MG Oral TabletPSN9188ab17-8539-48a5-905f-ad35ab5a0b939
197418bumetanide 1 MG Oral TabletPSN9188ab17-8539-48a5-905f-ad35ab5a0b939
197419bumetanide 2 MG Oral TabletPSN9188ab17-8539-48a5-905f-ad35ab5a0b939
197417bumetanide 0.5 MG Oral TabletSCD9188ab17-8539-48a5-905f-ad35ab5a0b939
197418bumetanide 1 MG Oral TabletSCD9188ab17-8539-48a5-905f-ad35ab5a0b939
197419bumetanide 2 MG Oral TabletSCD9188ab17-8539-48a5-905f-ad35ab5a0b939
197419bumetanide 2 MG Oral TabletPSNc8e243c0-805a-4d81-bec9-f5be6eb9f2bc7
197419bumetanide 2 MG Oral TabletSCDc8e243c0-805a-4d81-bec9-f5be6eb9f2bc7
197417bumetanide 0.5 MG Oral TabletPSN87385a0a-e7e6-8b7f-e053-2991aa0aa21a5
197418bumetanide 1 MG Oral TabletPSN87385a0a-e7e6-8b7f-e053-2991aa0aa21a5
197419bumetanide 2 MG Oral TabletPSN87385a0a-e7e6-8b7f-e053-2991aa0aa21a5
197417bumetanide 0.5 MG Oral TabletSCD87385a0a-e7e6-8b7f-e053-2991aa0aa21a5
197418bumetanide 1 MG Oral TabletSCD87385a0a-e7e6-8b7f-e053-2991aa0aa21a5
197419bumetanide 2 MG Oral TabletSCD87385a0a-e7e6-8b7f-e053-2991aa0aa21a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1491-169238149101100 TABLET in 1 BOTTLE (69238-1491-1) 100 tablet2017-10-180000-00-00NoNoCurrent
69238-1491-569238149105500 TABLET in 1 BOTTLE (69238-1491-5) 500 tablet2017-10-180000-00-00NoNoCurrent