Torsemide

Product NDC
63629-4475
11-digit product format
636294475
Labeler code
63629
Product ID
63629-4475_ffbae910-272e-42a8-9703-2c3768146699
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Torsemide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079234
Marketing category
ANDA
Marketing start
2009-01-27
Marketing end
0000-00-00
Substance
TORSEMIDE
Active strength
20 mg/1
Pharmacologic classes
Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-4475DDiscontinued by firm2026-08-03
excluded packagepackage63629-447563629-4475-1DDiscontinued by firm2026-08-03

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4475-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4475-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4475-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4475-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4475-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4475-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-4475-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-4475-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-4475-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-4475-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-4475-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-4475-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-4475-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-4475-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-4475-1IInactivated by FDA110d247fa046…a55b01930146…

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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-4475-12021-06-01C16284748780-19855d018-d487-cd31-e053-dbdaa90ab51aTORSEMIDE TABLETS Rx only
63629-4475-12019-11-27C16284748780-19855d018-d487-cd31-e053-dbdaa90ab51aTORSEMIDE TABLETS Rx only

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TORSEMIDEACTIVE INGREDIENTW31X2H97FBTORSEMIDE TABLET [BRYANT RANCH PREPACK]2
TORSEMIDEACTIVE MOIETYW31X2H97FBTORSEMIDE TABLET [BRYANT RANCH PREPACK]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTORSEMIDE TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTORSEMIDE TABLET [BRYANT RANCH PREPACK]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTORSEMIDE TABLET [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTORSEMIDE TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TORSEMIDE TABLET [BRYANT RANCH PREPACK]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ETORSEMIDE TABLET [BRYANT RANCH PREPACK]2

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
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