Torsemide

Product NDC
71335-2143
11-digit product format
713352143
Labeler code
71335
Product ID
71335-2143_8bd378c8-5742-4ee7-adb8-65bdf1f07b35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Torsemide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078249
Marketing category
ANDA
Marketing start
2007-10-17
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

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
A078249-001TORSEMIDETORSEMIDE5MGTABLET / ORALAB2007-10-17
A078249-002TORSEMIDETORSEMIDE10MGTABLET / ORALAB2007-10-17
A078249-003TORSEMIDETORSEMIDE20MGTABLET / ORALAB2007-10-17
A078249-004TORSEMIDETORSEMIDE100MGTABLET / ORALAB2007-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078249-001AB
A078249-002AB
A078249-003AB
A078249-004AB

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 UTC2026-02A078249-001TORSEMIDE5MGTABLET / ORALAB2007-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078249-002TORSEMIDE10MGTABLET / ORALAB2007-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078249-003TORSEMIDE20MGTABLET / ORALAB2007-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078249-004TORSEMIDE100MGTABLET / ORALAB2007-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078249-001TORSEMIDE5MGTABLET / ORALAB2007-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078249-002TORSEMIDE10MGTABLET / ORALAB2007-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078249-003TORSEMIDE20MGTABLET / ORALAB2007-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078249-004TORSEMIDE100MGTABLET / ORALAB2007-10-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078249-001TORSEMIDE5MGTABLET / ORALAB2007-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078249-002TORSEMIDE10MGTABLET / ORALAB2007-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078249-003TORSEMIDE20MGTABLET / ORALAB2007-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078249-004TORSEMIDE100MGTABLET / ORALAB2007-10-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078249-001TORSEMIDE5MGTABLET / ORALAB2007-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078249-002TORSEMIDE10MGTABLET / ORALAB2007-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078249-003TORSEMIDE20MGTABLET / ORALAB2007-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078249-004TORSEMIDE100MGTABLET / ORALAB2007-10-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078249-001TORSEMIDE5MGTABLET / ORALAB2007-10-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078249-002TORSEMIDE10MGTABLET / ORALAB2007-10-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078249-003TORSEMIDE20MGTABLET / ORALAB2007-10-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078249-004TORSEMIDE100MGTABLET / ORALAB2007-10-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078249-001TORSEMIDE5MGTABLET / ORALAB2007-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078249-002TORSEMIDE10MGTABLET / ORALAB2007-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078249-003TORSEMIDE20MGTABLET / ORALAB2007-10-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078249-004TORSEMIDE100MGTABLET / ORALAB2007-10-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078249-001TORSEMIDE5MGTABLET / ORALAB2007-10-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078249-002TORSEMIDE10MGTABLET / ORALAB2007-10-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078249-003TORSEMIDE20MGTABLET / ORALAB2007-10-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078249-004TORSEMIDE100MGTABLET / ORALAB2007-10-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078249-001TORSEMIDE5MGTABLET / ORALAB2007-10-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078249-002TORSEMIDE10MGTABLET / ORALAB2007-10-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078249-003TORSEMIDE20MGTABLET / ORALAB2007-10-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078249-004TORSEMIDE100MGTABLET / ORALAB2007-10-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078249-001TORSEMIDE5MGTABLET / ORALAB2007-10-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078249-002TORSEMIDE10MGTABLET / ORALAB2007-10-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078249-003TORSEMIDE20MGTABLET / ORALAB2007-10-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078249-004TORSEMIDE100MGTABLET / ORALAB2007-10-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078249-001TORSEMIDE5MGTABLET / ORALAB2007-10-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A078249-002TORSEMIDE10MGTABLET / ORALAB2007-10-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A078249-003TORSEMIDE20MGTABLET / ORALAB2007-10-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A078249-004TORSEMIDE100MGTABLET / ORALAB2007-10-17d06236e962d9…

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 UTC2026-02A078249-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078249-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078249-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078249-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078249-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078249-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078249-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078249-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078249-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078249-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078249-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078249-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078249-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078249-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078249-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078249-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078249-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078249-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078249-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078249-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078249-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078249-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078249-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078249-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078249-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078249-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078249-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078249-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078249-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078249-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078249-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078249-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078249-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078249-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078249-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078249-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078249-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078249-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078249-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078249-004AB1d06236e962d9…

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
13d851b6-3355-4541-93e8-73cdaf0f13d1Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2143-1Torsemide100 in 1 BOTTLETABLET100103
71335-2143-2Torsemide30 in 1 BOTTLETABLET30103
71335-2143-3Torsemide90 in 1 BOTTLETABLET90103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2143TORSEMIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 3 package rows20240726_13d851b6-3355-4541-93e8-73cdaf0f13d1.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TorsemideTORSEMIDERedpharm Drug44f2f06d-7bc4-5239-e063-6394a90aac5e2025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078249
application number: ANDA078249
TorsemideTORSEMIDEBryant Ranch Prepack13d851b6-3355-4541-93e8-73cdaf0f13d12024-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078249
application number: ANDA078249
ndc (product): 71335-2143
TorsemideTORSEMIDEAurobindo Pharma Limited55e88727-864e-4313-860c-31a6ca45168f2024-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078249
application number: ANDA078249
TorsemideTORSEMIDERising Pharma Holdings, Inc.3c8f1c0b-8a44-4ca0-b2cf-3c591f8878fd2024-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078249
application number: ANDA078249

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198369torsemide 10 MG Oral TabletPSN13d851b6-3355-4541-93e8-73cdaf0f13d1103
198369torsemide 10 MG Oral TabletSCD13d851b6-3355-4541-93e8-73cdaf0f13d1103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2143-171335214301100 TABLET in 1 BOTTLE (71335-2143-1) 100 tablet2024-07-160000-00-00NoNoCurrent
71335-2143-27133521430230 TABLET in 1 BOTTLE (71335-2143-2) 30 tablet2023-05-020000-00-00NoNoCurrent
71335-2143-37133521430390 TABLET in 1 BOTTLE (71335-2143-3) 90 tablet2024-07-160000-00-00NoNoCurrent