Home NDC 57237-139 Torsemide
Product NDC 57237-139
11-digit product format 572370139
Labeler code 57237
Product ID 57237-139_e5f7dcb0-8cfe-4318-a407-72f1c47e0680
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Torsemide
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078249-001 TORSEMIDE TORSEMIDE 5MG TABLET / ORAL AB 2007-10-17 A078249-002 TORSEMIDE TORSEMIDE 10MG TABLET / ORAL AB 2007-10-17 A078249-003 TORSEMIDE TORSEMIDE 20MG TABLET / ORAL AB 2007-10-17 A078249-004 TORSEMIDE TORSEMIDE 100MG TABLET / ORAL AB 2007-10-17
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 A078249-001 TORSEMIDE 5MG TABLET / ORAL AB 2007-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078249-002 TORSEMIDE 10MG TABLET / ORAL AB 2007-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078249-003 TORSEMIDE 20MG TABLET / ORAL AB 2007-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078249-004 TORSEMIDE 100MG TABLET / ORAL AB 2007-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078249-001 TORSEMIDE 5MG TABLET / ORAL AB 2007-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078249-002 TORSEMIDE 10MG TABLET / ORAL AB 2007-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078249-003 TORSEMIDE 20MG TABLET / ORAL AB 2007-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078249-004 TORSEMIDE 100MG TABLET / ORAL AB 2007-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078249-001 TORSEMIDE 5MG TABLET / ORAL AB 2007-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078249-002 TORSEMIDE 10MG TABLET / ORAL AB 2007-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078249-003 TORSEMIDE 20MG TABLET / ORAL AB 2007-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078249-004 TORSEMIDE 100MG TABLET / ORAL AB 2007-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078249-001 TORSEMIDE 5MG TABLET / ORAL AB 2007-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078249-002 TORSEMIDE 10MG TABLET / ORAL AB 2007-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078249-003 TORSEMIDE 20MG TABLET / ORAL AB 2007-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078249-004 TORSEMIDE 100MG TABLET / ORAL AB 2007-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078249-001 TORSEMIDE 5MG TABLET / ORAL AB 2007-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078249-002 TORSEMIDE 10MG TABLET / ORAL AB 2007-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078249-003 TORSEMIDE 20MG TABLET / ORAL AB 2007-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078249-004 TORSEMIDE 100MG TABLET / ORAL AB 2007-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078249-001 TORSEMIDE 5MG TABLET / ORAL AB 2007-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078249-002 TORSEMIDE 10MG TABLET / ORAL AB 2007-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078249-003 TORSEMIDE 20MG TABLET / ORAL AB 2007-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078249-004 TORSEMIDE 100MG TABLET / ORAL AB 2007-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078249-001 TORSEMIDE 5MG TABLET / ORAL AB 2007-10-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078249-002 TORSEMIDE 10MG TABLET / ORAL AB 2007-10-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078249-003 TORSEMIDE 20MG TABLET / ORAL AB 2007-10-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078249-004 TORSEMIDE 100MG TABLET / ORAL AB 2007-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078249-001 TORSEMIDE 5MG TABLET / ORAL AB 2007-10-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078249-002 TORSEMIDE 10MG TABLET / ORAL AB 2007-10-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078249-003 TORSEMIDE 20MG TABLET / ORAL AB 2007-10-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078249-004 TORSEMIDE 100MG TABLET / ORAL AB 2007-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078249-001 TORSEMIDE 5MG TABLET / ORAL AB 2007-10-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078249-002 TORSEMIDE 10MG TABLET / ORAL AB 2007-10-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078249-003 TORSEMIDE 20MG TABLET / ORAL AB 2007-10-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078249-004 TORSEMIDE 100MG TABLET / ORAL AB 2007-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078249-001 TORSEMIDE 5MG TABLET / ORAL AB 2007-10-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078249-002 TORSEMIDE 10MG TABLET / ORAL AB 2007-10-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078249-003 TORSEMIDE 20MG TABLET / ORAL AB 2007-10-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078249-004 TORSEMIDE 100MG TABLET / ORAL AB 2007-10-17 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TORSEMIDE 10 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 57237-139-01 Torsemide 100 in 1 BOTTLE TABLET 100 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57237-139 TORSEMIDE TABLET [RISING PHARMA HOLDINGS, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20240515_3c8f1c0b-8a44-4ca0-b2cf-3c591f8878fd.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.
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 57237-139-01 57237013901 100 TABLET in 1 BOTTLE (57237-139-01) 100 tablet 2007-10-17 0000-00-00 No No Current