Home NDC 42291-816 Torsemide
Product NDC 42291-816
11-digit product format 422910816
Labeler code 42291
Product ID 42291-816_4a94f559-d26f-5817-e063-6294a90ab408
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Torsemide
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA076346
Marketing category ANDA
Marketing start 2017-04-03
Substance TORSEMIDE
Active strength 5 mg/1
Pharmacologic classes Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076346-001 TORSEMIDE TORSEMIDE 5MG TABLET / ORAL AB 2003-05-30 A076346-002 TORSEMIDE TORSEMIDE 10MG TABLET / ORAL AB 2003-05-30 A076346-003 TORSEMIDE TORSEMIDE 20MG TABLET / ORAL AB RS 2003-05-30 A076346-004 TORSEMIDE TORSEMIDE 100MG TABLET / ORAL AB 2004-10-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A076346-001 TORSEMIDE 5MG TABLET / ORAL AB 2003-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076346-002 TORSEMIDE 10MG TABLET / ORAL AB 2003-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076346-003 TORSEMIDE 20MG TABLET / ORAL AB RS 2003-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076346-004 TORSEMIDE 100MG TABLET / ORAL AB 2004-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076346-001 TORSEMIDE 5MG TABLET / ORAL AB 2003-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076346-002 TORSEMIDE 10MG TABLET / ORAL AB 2003-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076346-003 TORSEMIDE 20MG TABLET / ORAL AB RS 2003-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076346-004 TORSEMIDE 100MG TABLET / ORAL AB 2004-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076346-001 TORSEMIDE 5MG TABLET / ORAL AB 2003-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076346-002 TORSEMIDE 10MG TABLET / ORAL AB 2003-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076346-003 TORSEMIDE 20MG TABLET / ORAL AB RS 2003-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076346-004 TORSEMIDE 100MG TABLET / ORAL AB 2004-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076346-001 TORSEMIDE 5MG TABLET / ORAL AB 2003-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076346-002 TORSEMIDE 10MG TABLET / ORAL AB 2003-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076346-003 TORSEMIDE 20MG TABLET / ORAL AB RS 2003-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076346-004 TORSEMIDE 100MG TABLET / ORAL AB 2004-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076346-001 TORSEMIDE 5MG TABLET / ORAL AB 2003-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076346-002 TORSEMIDE 10MG TABLET / ORAL AB 2003-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076346-003 TORSEMIDE 20MG TABLET / ORAL AB RS 2003-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076346-004 TORSEMIDE 100MG TABLET / ORAL AB 2004-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076346-001 TORSEMIDE 5MG TABLET / ORAL AB 2003-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076346-002 TORSEMIDE 10MG TABLET / ORAL AB 2003-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076346-003 TORSEMIDE 20MG TABLET / ORAL AB RS 2003-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076346-004 TORSEMIDE 100MG TABLET / ORAL AB 2004-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076346-001 TORSEMIDE 5MG TABLET / ORAL AB 2003-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076346-002 TORSEMIDE 10MG TABLET / ORAL AB 2003-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076346-003 TORSEMIDE 20MG TABLET / ORAL AB RS 2003-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076346-004 TORSEMIDE 100MG TABLET / ORAL AB 2004-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076346-001 TORSEMIDE 5MG TABLET / ORAL AB 2003-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076346-002 TORSEMIDE 10MG TABLET / ORAL AB 2003-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076346-003 TORSEMIDE 20MG TABLET / ORAL AB RS 2003-05-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076346-004 TORSEMIDE 100MG TABLET / ORAL AB 2004-10-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076346-001 TORSEMIDE 5MG TABLET / ORAL AB 2003-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076346-002 TORSEMIDE 10MG TABLET / ORAL AB 2003-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076346-003 TORSEMIDE 20MG TABLET / ORAL AB RS 2003-05-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076346-004 TORSEMIDE 100MG TABLET / ORAL AB 2004-10-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076346-001 TORSEMIDE 5MG TABLET / ORAL AB 2003-05-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076346-002 TORSEMIDE 10MG TABLET / ORAL AB 2003-05-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076346-003 TORSEMIDE 20MG TABLET / ORAL AB RS 2003-05-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076346-004 TORSEMIDE 100MG TABLET / ORAL AB 2004-10-19 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Torsemide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TORSEMIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W31X2H97FB Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198369 Internal RxNorm lookup 198370 Internal RxNorm lookup 198371 Internal RxNorm lookup 198372 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-816-90 Torsemide 90 in 1 BOTTLE TABLET 90 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TORSEMIDE ACTIVE INGREDIENT W31X2H97FB TORSEMIDE TABLET [AVKARE, INC.] 2 TORSEMIDE ACTIVE MOIETY W31X2H97FB TORSEMIDE TABLET [AVKARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TORSEMIDE TABLET [AVKARE, INC.] 2 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 TORSEMIDE TABLET [AVKARE, INC.] 2 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 TORSEMIDE TABLET [AVKARE, INC.] 2 Sodium Starch Glycolate Type A Potato INACTIVE INGREDIENT 5856J3G2A2 TORSEMIDE TABLET [AVKARE, INC.] 2 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ TORSEMIDE TABLET [AVKARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-816 TORSEMIDE TABLET [AVKARE] 7 Current NDC, Legacy NDC, 1 package rows 20230316_7fc14338-92e4-cf57-a3e8-ef64d8d1026c.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-816-90 42291081690 90 TABLET in 1 BOTTLE (42291-816-90) 90 tablet 2017-04-03 0000-00-00 No No Current