FDA.reportPublic FDA data

Torsemide

Product NDC
70518-2195
11-digit product format
705182195
Labeler code
70518
Product ID
70518-2195_49dcd3b1-3175-b12b-e063-6294a90ac92c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Torsemide
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076943
Marketing category
ANDA
Marketing start
2019-07-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Torsemide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TORSEMIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW31X2H97FB
Rxcui198371

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2195-02023-03-08C16284748780-1f386c64a-2bba-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TORSEMIDE TABLETS safely and effectively. See full prescribing information for TORSEMIDE TABLETS. TORSEMIDE tablets, for oral use Initial U.S. Approval: 1993
70518-2195-02023-01-30C16284748780-1f386c64a-2bba-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use TORSEMIDE TABLETS safely and effectively. See full prescribing information for TORSEMIDE TABLETS. TORSEMIDE tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2195-0Torsemide90 in 1 BOTTLE, PLASTICTABLET906
70518-2195-1Torsemide90 in 1 BOTTLE, PLASTICTABLET906

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198371torsemide 20 MG Oral TabletPSN1c755d94-b846-4336-a968-aa1b92dc0ac06
198371torsemide 20 MG Oral TabletSCD1c755d94-b846-4336-a968-aa1b92dc0ac06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2195-07051821950090 TABLET in 1 BOTTLE, PLASTIC (70518-2195-0) 90 tablet2019-07-090000-00-00NoNoCurrent
70518-2195-17051821950190 TABLET in 1 BOTTLE, PLASTIC (70518-2195-1) 90 tablet2025-06-27NoNoCurrent