Torsemide

Product NDC
70518-2744
Requested package NDC
70518-2744-1
11-digit product format
705182744
Labeler code
70518
Product ID
70518-2744_ed746c0a-93e1-374a-e053-2a95a90a6337
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Torsemide
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA079234
Marketing category
ANDA
Marketing start
2020-05-13
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
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-274470518-2744-1DDiscontinued 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 · 2 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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-274470518-2744-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-274470518-2744-1DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2744TORSEMIDE TABLET [REMEDYREPACK INC.]7Legacy NDC20250402_c8081bac-5f4e-4eb0-9099-17e2a519e77a.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2744-17051827440130 TABLET in 1 BLISTER PACK (70518-2744-1) 30 tablet2021-08-120000-00-00NoNoCurrent