FDA.reportPublic FDA data

Torsemide

Product NDC
63629-1346
11-digit product format
636291346
Labeler code
63629
Product ID
63629-1346_fc630aac-990b-e3c1-e053-6394a90af178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Torsemide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079234
Marketing category
ANDA
Marketing start
2011-01-01
Substance
TORSEMIDE
Active strength
10 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
TORSEMIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW31X2H97FB
Rxcui198369

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
63629-1346-12020-09-17C16284748780-19d75b9cf-fa6a-f424-e053-dadaa90a57ceThese 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
63629-1346-22020-09-17C16284748780-19d75b9cf-fa6a-f424-e053-dadaa90a57ceThese 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
63629-1346-12020-01-31C16284748780-19d75b9cf-fa6a-f424-e053-dadaa90a57ceThese 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
63629-1346-22020-01-31C16284748780-19d75b9cf-fa6a-f424-e053-dadaa90a57ceThese 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
63629-1346-1Torsemide100 in 1 BOTTLETABLET1001006
63629-1346-2Torsemide30 in 1 BOTTLETABLET301006
63629-1346-3Torsemide90 in 1 BOTTLETABLET901006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1346-1EA - Each63629-134657ec79eb-285c-492a-81ae-4c2b9818677712013-02-13
63629-1346-2EA - Each63629-1346603136cf-bd92-46cd-8366-411256978bd112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TORSEMIDEACTIVE INGREDIENTW31X2H97FBTORSEMIDE TABLET [BRYANT RANCH PREPACK]1000
TORSEMIDEACTIVE MOIETYW31X2H97FBTORSEMIDE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTORSEMIDE TABLET [BRYANT RANCH PREPACK]1000
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTORSEMIDE TABLET [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTORSEMIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TORSEMIDE TABLET [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94ETORSEMIDE TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1346TORSEMIDE (TORSEMIDE) TABLET [BRYANT RANCH PREPACK]1006Current NDC, Legacy NDC, 3 package rows20230526_f24151c8-02cd-4b07-a7fd-796903210aba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198369torsemide 10 MG Oral TabletPSNf24151c8-02cd-4b07-a7fd-796903210aba1006
198369torsemide 10 MG Oral TabletSCDf24151c8-02cd-4b07-a7fd-796903210aba1006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1346-163629134601100 TABLET in 1 BOTTLE (63629-1346-1) 100 tablet2012-03-010000-00-00NoNoCurrent
63629-1346-26362913460230 TABLET in 1 BOTTLE (63629-1346-2) 30 tablet2012-03-010000-00-00NoNoCurrent
63629-1346-36362913460390 TABLET in 1 BOTTLE (63629-1346-3) 90 tablet2012-03-010000-00-00NoNoCurrent