Torsemide

Product NDC: 71335-0297
Requested package NDC: 71335-0297-3
11-digit product format: 713350297
Labeler code: 71335
Product ID: 71335-0297_d54357a9-994d-4ffc-ba07-2f200d48f08c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Torsemide
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078249
Marketing category: ANDA
Marketing start: 2007-10-17
Marketing end: 0000-00-00
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: 2021-12-31
Current FDA listing: Historical FDA.report record

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-0297	71335-0297-3	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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.

Application-product, TE code table
Application-product	TE code
A078249-001	AB
A078249-002	AB
A078249-003	AB
A078249-004	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078249-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078249-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078249-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078249-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078249-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078249-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078249-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078249-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078249-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078249-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078249-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078249-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078249-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078249-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078249-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078249-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078249-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078249-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078249-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078249-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078249-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078249-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078249-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078249-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078249-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078249-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078249-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078249-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078249-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078249-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078249-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078249-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078249-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078249-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078249-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078249-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078249-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078249-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078249-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078249-004	AB	1	`d06236e962d9…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Torsemide	TORSEMIDE	Redpharm Drug	44f2f06d-7bc4-5239-e063-6394a90aac5e	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078249 application number: ANDA078249
Torsemide	TORSEMIDE	Bryant Ranch Prepack	13d851b6-3355-4541-93e8-73cdaf0f13d1	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078249 application number: ANDA078249
Torsemide	TORSEMIDE	Aurobindo Pharma Limited	55e88727-864e-4313-860c-31a6ca45168f	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078249 application number: ANDA078249
Torsemide	TORSEMIDE	Rising Pharma Holdings, Inc.	3c8f1c0b-8a44-4ca0-b2cf-3c591f8878fd	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078249 application number: ANDA078249

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W31X2H97FB	TORSEMIDE	56211-40-6	TORSEMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0297-3	71335029703	90 TABLET in 1 BOTTLE (71335-0297-3)	90 tablet	2017-08-07	0000-00-00	No	No	Current