Torsemide

Product NDC
50111-916
11-digit product format
501110916
Labeler code
50111
Product ID
50111-916_4ff14943-97b8-4b1c-8600-95c1e3540008
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Torsemide
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA076346
Marketing category
ANDA
Marketing start
2004-06-01
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

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
A076346-001TORSEMIDETORSEMIDE5MGTABLET / ORALAB2003-05-30
A076346-002TORSEMIDETORSEMIDE10MGTABLET / ORALAB2003-05-30
A076346-003TORSEMIDETORSEMIDE20MGTABLET / ORALABRS2003-05-30
A076346-004TORSEMIDETORSEMIDE100MGTABLET / ORALAB2004-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076346-001AB
A076346-002AB
A076346-003AB
A076346-004AB

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 UTC2026-02A076346-001TORSEMIDE5MGTABLET / ORALAB2003-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076346-002TORSEMIDE10MGTABLET / ORALAB2003-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076346-003TORSEMIDE20MGTABLET / ORALABRS2003-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076346-004TORSEMIDE100MGTABLET / ORALAB2004-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076346-001TORSEMIDE5MGTABLET / ORALAB2003-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076346-002TORSEMIDE10MGTABLET / ORALAB2003-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076346-003TORSEMIDE20MGTABLET / ORALABRS2003-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076346-004TORSEMIDE100MGTABLET / ORALAB2004-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076346-001TORSEMIDE5MGTABLET / ORALAB2003-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076346-002TORSEMIDE10MGTABLET / ORALAB2003-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076346-003TORSEMIDE20MGTABLET / ORALABRS2003-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076346-004TORSEMIDE100MGTABLET / ORALAB2004-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076346-001TORSEMIDE5MGTABLET / ORALAB2003-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076346-002TORSEMIDE10MGTABLET / ORALAB2003-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076346-003TORSEMIDE20MGTABLET / ORALABRS2003-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076346-004TORSEMIDE100MGTABLET / ORALAB2004-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076346-001TORSEMIDE5MGTABLET / ORALAB2003-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076346-002TORSEMIDE10MGTABLET / ORALAB2003-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076346-003TORSEMIDE20MGTABLET / ORALABRS2003-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076346-004TORSEMIDE100MGTABLET / ORALAB2004-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076346-001TORSEMIDE5MGTABLET / ORALAB2003-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076346-002TORSEMIDE10MGTABLET / ORALAB2003-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076346-003TORSEMIDE20MGTABLET / ORALABRS2003-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076346-004TORSEMIDE100MGTABLET / ORALAB2004-10-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076346-001TORSEMIDE5MGTABLET / ORALAB2003-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076346-002TORSEMIDE10MGTABLET / ORALAB2003-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076346-003TORSEMIDE20MGTABLET / ORALABRS2003-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076346-004TORSEMIDE100MGTABLET / ORALAB2004-10-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076346-001TORSEMIDE5MGTABLET / ORALAB2003-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076346-002TORSEMIDE10MGTABLET / ORALAB2003-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076346-003TORSEMIDE20MGTABLET / ORALABRS2003-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076346-004TORSEMIDE100MGTABLET / ORALAB2004-10-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076346-001TORSEMIDE5MGTABLET / ORALAB2003-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076346-002TORSEMIDE10MGTABLET / ORALAB2003-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076346-003TORSEMIDE20MGTABLET / ORALABRS2003-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076346-004TORSEMIDE100MGTABLET / ORALAB2004-10-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076346-001TORSEMIDE5MGTABLET / ORALAB2003-05-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A076346-002TORSEMIDE10MGTABLET / ORALAB2003-05-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A076346-003TORSEMIDE20MGTABLET / ORALABRS2003-05-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A076346-004TORSEMIDE100MGTABLET / ORALAB2004-10-19d06236e962d9…

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 UTC2026-02A076346-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076346-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076346-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076346-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076346-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076346-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076346-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076346-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076346-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076346-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076346-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076346-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076346-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076346-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076346-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076346-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076346-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076346-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076346-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076346-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076346-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076346-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076346-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076346-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076346-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076346-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076346-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076346-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076346-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076346-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076346-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076346-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076346-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076346-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076346-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076346-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076346-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076346-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076346-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076346-004AB1d06236e962d9…

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 · 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
8a95cbdb-0601-47a5-9b3a-0c3b0629ceb9Available 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
50111-916-01Torsemide100 in 1 BOTTLETABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50111-916-01EA - Each50111-916bdcd50d2-e020-4d35-a811-3d131fda68cd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TORSEMIDEACTIVE INGREDIENTW31X2H97FBTORSEMIDE TABLET [PLIVA, INC]4
TORSEMIDEACTIVE MOIETYW31X2H97FBTORSEMIDE TABLET [PLIVA, INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTORSEMIDE TABLET [PLIVA, INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TORSEMIDE TABLET [PLIVA, INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TORSEMIDE TABLET [PLIVA, INC]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TORSEMIDE TABLET [PLIVA, INC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTORSEMIDE TABLET [PLIVA, INC]4
TORSEMIDEACTIVE INGREDIENTW31X2H97FBTORSEMIDE TABLET [AVKARE, INC.]2
TORSEMIDEACTIVE MOIETYW31X2H97FBTORSEMIDE TABLET [AVKARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTORSEMIDE TABLET [AVKARE, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30TORSEMIDE TABLET [AVKARE, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4TORSEMIDE TABLET [AVKARE, INC.]2
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2TORSEMIDE TABLET [AVKARE, INC.]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJTORSEMIDE TABLET [AVKARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50111-916TORSEMIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]10Current NDC, Legacy NDC, 1 package rows20211028_8a95cbdb-0601-47a5-9b3a-0c3b0629ceb9.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TorsemideTORSEMIDEAvKARE7fc14338-92e4-cf57-a3e8-ef64d8d1026c2026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076346
application number: ANDA076346
TorsemideTORSEMIDENCS HealthCare of KY, LLC dba Vangard Labs99b537f3-1fbf-48b7-ac3e-0a43e6aab3132024-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076346
application number: ANDA076346
TorsemideTORSEMIDEA-S Medication Solutions3e9c6ee1-c49f-4f59-9391-8a9b57becb022023-05-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076346
application number: ANDA076346
TorsemideTORSEMIDEA-S Medication Solutions3ed913ba-f0c0-4ba5-9440-73c4374f42262023-05-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076346
application number: ANDA076346
TorsemideTORSEMIDETeva Pharmaceuticals USA, Inc.8a95cbdb-0601-47a5-9b3a-0c3b0629ceb92017-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076346
application number: ANDA076346
ndc (product): 50111-916

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198369torsemide 10 MG Oral TabletPSN8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198370torsemide 100 MG Oral TabletPSN8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198371torsemide 20 MG Oral TabletPSN8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198372torsemide 5 MG Oral TabletPSN8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198369torsemide 10 MG Oral TabletSCD8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198370torsemide 100 MG Oral TabletSCD8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198371torsemide 20 MG Oral TabletSCD8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198372torsemide 5 MG Oral TabletSCD8a95cbdb-0601-47a5-9b3a-0c3b0629ceb911
198369torsemide 10 MG Oral TabletPSN7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198370torsemide 100 MG Oral TabletPSN7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198371torsemide 20 MG Oral TabletPSN7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198372torsemide 5 MG Oral TabletPSN7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198369torsemide 10 MG Oral TabletSCD7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198370torsemide 100 MG Oral TabletSCD7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198371torsemide 20 MG Oral TabletSCD7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198372torsemide 5 MG Oral TabletSCD7fc14338-92e4-cf57-a3e8-ef64d8d1026c9
198369torsemide 10 MG Oral TabletPSN99b537f3-1fbf-48b7-ac3e-0a43e6aab3131
198369torsemide 10 MG Oral TabletSCD99b537f3-1fbf-48b7-ac3e-0a43e6aab3131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50111-916-0150111091601100 TABLET in 1 BOTTLE (50111-916-01) 100 tablet2004-06-010000-00-00NoNoCurrent