Home NDC 51407-362 Torsemide
Product NDC 51407-362
11-digit product format 514070362
Labeler code 51407
Product ID 51407-362_0d9921c1-ead4-6cc5-e063-6294a90a7d81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Torsemide
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA076943
Marketing category ANDA
Marketing start 2005-03-01
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076943-001 TORSEMIDE TORSEMIDE 5MG TABLET / ORAL 2005-03-01 A076943-002 TORSEMIDE TORSEMIDE 10MG TABLET / ORAL 2005-03-01 A076943-003 TORSEMIDE TORSEMIDE 20MG TABLET / ORAL AB 2005-03-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076943-003 AB
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 4 · 123 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 A076943-001 TORSEMIDE 5MG TABLET / ORAL 2005-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076943-002 TORSEMIDE 10MG TABLET / ORAL 2005-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076943-003 TORSEMIDE 20MG TABLET / ORAL AB 2005-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076943-001 TORSEMIDE 5MG TABLET / ORAL 2005-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076943-002 TORSEMIDE 10MG TABLET / ORAL 2005-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076943-003 TORSEMIDE 20MG TABLET / ORAL AB 2005-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076943-001 TORSEMIDE 5MG TABLET / ORAL AB 2005-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076943-002 TORSEMIDE 10MG TABLET / ORAL AB 2005-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076943-003 TORSEMIDE 20MG TABLET / ORAL AB 2005-03-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076943-001 TORSEMIDE 5MG TABLET / ORAL AB 2005-03-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076943-002 TORSEMIDE 10MG TABLET / ORAL AB 2005-03-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076943-003 TORSEMIDE 20MG TABLET / ORAL AB 2005-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076943-001 TORSEMIDE 5MG TABLET / ORAL AB 2005-03-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076943-002 TORSEMIDE 10MG TABLET / ORAL AB 2005-03-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076943-003 TORSEMIDE 20MG TABLET / ORAL AB 2005-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076943-001 TORSEMIDE 5MG TABLET / ORAL AB 2005-03-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076943-002 TORSEMIDE 10MG TABLET / ORAL AB 2005-03-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076943-003 TORSEMIDE 20MG TABLET / ORAL AB 2005-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076943-001 TORSEMIDE 5MG TABLET / ORAL AB 2005-03-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076943-002 TORSEMIDE 10MG TABLET / ORAL AB 2005-03-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076943-003 TORSEMIDE 20MG TABLET / ORAL AB 2005-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076943-001 TORSEMIDE 5MG TABLET / ORAL AB 2005-03-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076943-002 TORSEMIDE 10MG TABLET / ORAL AB 2005-03-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076943-003 TORSEMIDE 20MG TABLET / ORAL AB 2005-03-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076943-001 TORSEMIDE 5MG TABLET / ORAL AB 2005-03-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076943-002 TORSEMIDE 10MG TABLET / ORAL AB 2005-03-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076943-003 TORSEMIDE 20MG TABLET / ORAL AB 2005-03-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076943-001 TORSEMIDE 5MG TABLET / ORAL AB 2005-03-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076943-002 TORSEMIDE 10MG TABLET / ORAL AB 2005-03-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076943-003 TORSEMIDE 20MG TABLET / ORAL AB 2005-03-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076943-001 TORSEMIDE 5MG TABLET / ORAL AB 2005-03-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076943-002 TORSEMIDE 10MG TABLET / ORAL AB 2005-03-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076943-003 TORSEMIDE 20MG TABLET / ORAL AB 2005-03-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076943-001 TORSEMIDE 5MG TABLET / ORAL AB 2005-03-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076943-002 TORSEMIDE 10MG TABLET / ORAL AB 2005-03-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076943-003 TORSEMIDE 20MG TABLET / ORAL AB 2005-03-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076943-001 TORSEMIDE 5MG TABLET / ORAL AB 2005-03-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076943-002 TORSEMIDE 10MG TABLET / ORAL AB 2005-03-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076943-003 TORSEMIDE 20MG TABLET / ORAL AB 2005-03-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076943-001 TORSEMIDE 5MG TABLET / ORAL AB 2005-03-01 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 117 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Torsemide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TORSEMIDE 20 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198371 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 51407-362-90 Torsemide 90 in 1 BOTTLE, PLASTIC TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51407-362 TORSEMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20231229_a6055317-8826-df85-e053-2a95a90a5378.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Torsemide TORSEMIDE REMEDYREPACK INC. 1c755d94-b846-4336-a968-aa1b92dc0ac0 2026-07-21 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076943 application number: ANDA076943 Torsemide TORSEMIDE Aphena Pharma Solutions - Tennessee, LLC 159e8c90-ebc6-0991-e063-6394a90aae19 2024-04-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076943 application number: ANDA076943 Torsemide TORSEMIDE Golden State Medical Supply, Inc. a6055317-8826-df85-e053-2a95a90a5378 2023-12-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076943 application number: ANDA076943 ndc (product): 51407-362 Torsemide TORSEMIDE Hikma Pharmaceuticals USA Inc. fde1d1be-0faa-440a-9039-bdb103288c76 2023-08-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076943 application number: ANDA076943 Torsemide TORSEMIDE Aphena Pharma Solutions - Tennessee, LLC b869bc45-1ebb-42fb-82c5-603f09835790 2017-10-19 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076943 application number: ANDA076943
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 51407-362-90 51407036290 90 TABLET in 1 BOTTLE, PLASTIC (51407-362-90) 90 tablet 2020-03-11 0000-00-00 No No Current