FDA.reportPublic FDA data

Torsemide

Product NDC
50111-917
11-digit product format
501110917
Labeler code
50111
Product ID
50111-917_4ff14943-97b8-4b1c-8600-95c1e3540008
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Torsemide
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076346
Marketing category
ANDA
Marketing start
2004-06-01
Substance
TORSEMIDE
Active strength
20 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
TORSEMIDE20 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
50111-917-01Torsemide100 in 1 BOTTLETABLET10011
50111-917-03Torsemide1000 in 1 BOTTLETABLET100011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50111-917TORSEMIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]10Current NDC, Legacy NDC, 2 package rows20211028_8a95cbdb-0601-47a5-9b3a-0c3b0629ceb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198369torsemide 10 MG Oral TabletPSN8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198370torsemide 100 MG Oral TabletPSN8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198371torsemide 20 MG Oral TabletPSN8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198372torsemide 5 MG Oral TabletPSN8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198369torsemide 10 MG Oral TabletSCD8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198370torsemide 100 MG Oral TabletSCD8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198371torsemide 20 MG Oral TabletSCD8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198372torsemide 5 MG Oral TabletSCD8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198369torsemide 10 MG Oral TabletPSN7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198370torsemide 100 MG Oral TabletPSN7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198371torsemide 20 MG Oral TabletPSN7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198372torsemide 5 MG Oral TabletPSN7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198369torsemide 10 MG Oral TabletSCD7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198370torsemide 100 MG Oral TabletSCD7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198371torsemide 20 MG Oral TabletSCD7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198372torsemide 5 MG Oral TabletSCD7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198371torsemide 20 MG Oral TabletPSN3ed913ba-f0c0-4ba5-9440-73c4374f42261
198371torsemide 20 MG Oral TabletSCD3ed913ba-f0c0-4ba5-9440-73c4374f42261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50111-917-0150111091701100 TABLET in 1 BOTTLE (50111-917-01) 100 tablet2004-06-010000-00-00NoNoCurrent
50111-917-03501110917031000 TABLET in 1 BOTTLE (50111-917-03) 1000 tablet2004-06-010000-00-00NoNoCurrent