FDA.reportPublic FDA data

Torsemide

Product NDC
65862-128
11-digit product format
658620128
Labeler code
65862
Product ID
65862-128_e1cdbb1e-4104-41ee-86af-84fc73d761ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Torsemide
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078249
Marketing category
ANDA
Marketing start
2007-10-17
Substance
TORSEMIDE
Active strength
100 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
Torsemide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TORSEMIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW31X2H97FB
Rxcui198369, 198370, 198371, 198372

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4be7e40e-4a67-4791-ac86-36ee792616f1Product name120220118
71194f54-ef13-d3b7-9576-5c094148f9c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-128-01Torsemide100 in 1 BOTTLETABLET10017
65862-128-99Torsemide1000 in 1 BOTTLETABLET100017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-128TORSEMIDE TABLET [AUROBINDO PHARMA LIMITED]17Current NDC, Legacy NDC, 2 package rows20240509_55e88727-864e-4313-860c-31a6ca45168f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198369torsemide 10 MG Oral TabletPSN55e88727-864e-4313-860c-31a6ca45168f17
198370torsemide 100 MG Oral TabletPSN55e88727-864e-4313-860c-31a6ca45168f17
198371torsemide 20 MG Oral TabletPSN55e88727-864e-4313-860c-31a6ca45168f17
198372torsemide 5 MG Oral TabletPSN55e88727-864e-4313-860c-31a6ca45168f17
198369torsemide 10 MG Oral TabletSCD55e88727-864e-4313-860c-31a6ca45168f17
198370torsemide 100 MG Oral TabletSCD55e88727-864e-4313-860c-31a6ca45168f17
198371torsemide 20 MG Oral TabletSCD55e88727-864e-4313-860c-31a6ca45168f17
198372torsemide 5 MG Oral TabletSCD55e88727-864e-4313-860c-31a6ca45168f17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-128-0165862012801100 TABLET in 1 BOTTLE (65862-128-01) 100 tablet2007-10-170000-00-00NoNoCurrent
65862-128-26658620128262500 TABLET in 1 BAG (65862-128-26)2500 tablet17-OCT-07Current
65862-128-99658620128991000 TABLET in 1 BOTTLE (65862-128-99) 1000 tablet2007-10-170000-00-00NoNoCurrent