Torsemide

Product NDC
65862-127
Requested package NDC
65862-127-39
11-digit product format
658620127
Labeler code
65862
Product ID
65862-127_e1cdbb1e-4104-41ee-86af-84fc73d761ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Torsemide
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078249
Marketing category
ANDA
Marketing start
2007-10-17
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
2026-12-31
Current FDA listing
Yes

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
unfinished packagepackage65862-12765862-127-39UNFINISHEDActive or certified unfinished drug listing2026-08-03

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 · 21 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-305b2001dcd8f5…54b53d4dc9e4…

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
TORSEMIDE20 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198369Internal RxNorm lookup
198370Internal RxNorm lookup
198371Internal RxNorm lookup
198372Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
55e88727-864e-4313-860c-31a6ca45168fAvailable 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
65862-127-01Torsemide100 in 1 BOTTLETABLET10017
65862-127-99Torsemide1000 in 1 BOTTLETABLET100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-127-01EA - Each65862-12775a5ebe4-04ad-4c66-a5ca-3fd2168c255512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TORSEMIDEACTIVE INGREDIENTW31X2H97FBTORSEMIDE TABLET [AUROBINDO PHARMA LIMITED]11
TORSEMIDEACTIVE MOIETYW31X2H97FBTORSEMIDE TABLET [AUROBINDO PHARMA LIMITED]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTORSEMIDE TABLET [AUROBINDO PHARMA LIMITED]11
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTORSEMIDE TABLET [AUROBINDO PHARMA LIMITED]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTORSEMIDE TABLET [AUROBINDO PHARMA LIMITED]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TORSEMIDE TABLET [AUROBINDO PHARMA LIMITED]11
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTORSEMIDE TABLET [AUROBINDO PHARMA LIMITED]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-127TORSEMIDE TABLET [AUROBINDO PHARMA LIMITED]17Current NDC, Legacy NDC, 2 package rows20240509_55e88727-864e-4313-860c-31a6ca45168f.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
TorsemideTORSEMIDEAurobindo Pharma Limited55e88727-864e-4313-860c-31a6ca45168f2024-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078249
application number: ANDA078249
ndc (product): 65862-127
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 TabletPSN55e88727-864e-4313-860c-31a6ca45168f17
198370torsemide 100 MG Oral TabletPSN55e88727-864e-4313-860c-31a6ca45168f17
198371torsemide 20 MG Oral TabletPSN55e88727-864e-4313-860c-31a6ca45168f17
198372torsemide 5 MG Oral TabletPSN55e88727-864e-4313-860c-31a6ca45168f17
198369torsemide 10 MG Oral TabletSCD55e88727-864e-4313-860c-31a6ca45168f17
198370torsemide 100 MG Oral TabletSCD55e88727-864e-4313-860c-31a6ca45168f17
198371torsemide 20 MG Oral TabletSCD55e88727-864e-4313-860c-31a6ca45168f17
198372torsemide 5 MG Oral TabletSCD55e88727-864e-4313-860c-31a6ca45168f17
198371torsemide 20 MG Oral TabletPSN44f2f06d-7bc4-5239-e063-6394a90aac5e1
198371torsemide 20 MG Oral TabletSCD44f2f06d-7bc4-5239-e063-6394a90aac5e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
65862-127-39658620127393000 TABLET in 1 BAG (65862-127-39)3000 tablet17-OCT-07Current