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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct63629-1346IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-134663629-1346-1IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-134663629-1346-2IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079234-001TORSEMIDETORSEMIDE5MGTABLET / ORALAB2009-01-27
A079234-002TORSEMIDETORSEMIDE10MGTABLET / ORALAB2009-01-27
A079234-003TORSEMIDETORSEMIDE20MGTABLET / ORALAB2009-01-27
A079234-004TORSEMIDETORSEMIDE100MGTABLET / ORALAB2009-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A079234-001AB
A079234-002AB
A079234-003AB
A079234-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079234-001TORSEMIDE5MGTABLET / ORALAB2009-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079234-002TORSEMIDE10MGTABLET / ORALAB2009-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079234-003TORSEMIDE20MGTABLET / ORALAB2009-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079234-004TORSEMIDE100MGTABLET / ORALAB2009-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079234-001TORSEMIDE5MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079234-002TORSEMIDE10MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079234-003TORSEMIDE20MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079234-004TORSEMIDE100MGTABLET / ORALAB2009-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A079234-001TORSEMIDE5MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079234-002TORSEMIDE10MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079234-003TORSEMIDE20MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079234-004TORSEMIDE100MGTABLET / ORALAB2009-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079234-001TORSEMIDE5MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079234-002TORSEMIDE10MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079234-003TORSEMIDE20MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079234-004TORSEMIDE100MGTABLET / ORALAB2009-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079234-001TORSEMIDE5MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079234-002TORSEMIDE10MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079234-003TORSEMIDE20MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079234-004TORSEMIDE100MGTABLET / ORALAB2009-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079234-001TORSEMIDE5MGTABLET / ORALAB2009-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079234-002TORSEMIDE10MGTABLET / ORALAB2009-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079234-003TORSEMIDE20MGTABLET / ORALAB2009-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079234-004TORSEMIDE100MGTABLET / ORALAB2009-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079234-001TORSEMIDE5MGTABLET / ORALAB2009-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079234-002TORSEMIDE10MGTABLET / ORALAB2009-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079234-003TORSEMIDE20MGTABLET / ORALAB2009-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079234-004TORSEMIDE100MGTABLET / ORALAB2009-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079234-001TORSEMIDE5MGTABLET / ORALAB2009-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079234-002TORSEMIDE10MGTABLET / ORALAB2009-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079234-003TORSEMIDE20MGTABLET / ORALAB2009-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079234-004TORSEMIDE100MGTABLET / ORALAB2009-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079234-001TORSEMIDE5MGTABLET / ORALAB2009-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079234-002TORSEMIDE10MGTABLET / ORALAB2009-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079234-003TORSEMIDE20MGTABLET / ORALAB2009-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079234-004TORSEMIDE100MGTABLET / ORALAB2009-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079234-001TORSEMIDE5MGTABLET / ORALAB2009-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A079234-002TORSEMIDE10MGTABLET / ORALAB2009-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A079234-003TORSEMIDE20MGTABLET / ORALAB2009-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A079234-004TORSEMIDE100MGTABLET / ORALAB2009-01-27d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A079234-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079234-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079234-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079234-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079234-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079234-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079234-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079234-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079234-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079234-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079234-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079234-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079234-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079234-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079234-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079234-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079234-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079234-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079234-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079234-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079234-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079234-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079234-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079234-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079234-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079234-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079234-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079234-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079234-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079234-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079234-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079234-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079234-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079234-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079234-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079234-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079234-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079234-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079234-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079234-004AB1d06236e962d9…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W31X2H97FBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198369Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f24151c8-02cd-4b07-a7fd-796903210abaAvailable on FDA.report

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#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TorsemideTORSEMIDEMajor Pharmaceuticals09305350-e317-419c-96f5-aa8fbeb4044d2026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079234
application number: ANDA079234
TorsemideTORSEMIDEAvPAKf1439b9c-c01c-a6d4-594b-d92b8e0af26e2025-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079234
application number: ANDA079234
TORSEMIDETORSEMIDEDirect_Rx91d45625-5ba6-b50f-e053-2a95a90ac3142025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079234
application number: ANDA079234
TorsemideTORSEMIDEA-S Medication Solutionse58a7d1c-6584-44c3-98ce-a3e9b64e9c822024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079234
application number: ANDA079234
TorsemideTORSEMIDEAmerican Health Packagingaaabbaca-ba6f-42d5-980d-71135c7c80ea2024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079234
application number: ANDA079234
TorsemideTORSEMIDEA-S Medication Solutions05c8a6ee-9517-453f-8dd6-7e5ca83c5a682024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079234
application number: ANDA079234
TorsemideTORSEMIDEXLCare Pharmaceuticals Inc.234ff9d7-a02e-417f-a1f9-94038783cc772024-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079234
application number: ANDA079234
TorsemideTORSEMIDEBryant Ranch Prepackf24151c8-02cd-4b07-a7fd-796903210aba2023-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079234
application number: ANDA079234
ndc (product): 63629-1346
TorsemideTORSEMIDENCS HealthCare of KY, LLC dba Vangard Labs201e892d-d963-4c6a-b35b-c5780b01f6592022-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079234
application number: ANDA079234
TorsemideTORSEMIDECamber Pharmaceuticals, Inc.0d4a4ef9-0944-452c-b014-bd822bfb9dd92017-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079234
application number: ANDA079234

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