Torsemide

Product NDC: 67296-2190
Requested package NDC: 67296-2190-3
11-digit product format: 672962190
Labeler code: 67296
Product ID: 67296-2190_44f2f06d-7bc5-5239-e063-6394a90aac5e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Torsemide
Dosage form: TABLET
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA078249
Marketing category: ANDA
Marketing start: 2007-10-17
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 43.

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 · 172 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
2026-09-14 22:38:34	2026-08	A078249-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2007-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078249-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2007-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078249-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2007-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078249-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2007-10-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078249-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2007-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078249-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2007-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078249-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2007-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078249-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2007-10-17	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078249-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078249-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078249-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078249-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078249-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078249-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078249-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078249-004	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
44f2f06d-7bc4-5239-e063-6394a90aac5e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4be7e40e-4a67-4791-ac86-36ee792616f1	Product name	1	20220118
71194f54-ef13-d3b7-9576-5c094148f9c1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-2190-3	Torsemide	30 in 1 BOTTLE	TABLET	30		1

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 ndc (package): 67296-2190-3 ndc (product): 67296-2190 ndc11 (package): 67296219003
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198371	torsemide 20 MG Oral Tablet	PSN	44f2f06d-7bc4-5239-e063-6394a90aac5e	1
198371	torsemide 20 MG Oral Tablet	SCD	44f2f06d-7bc4-5239-e063-6394a90aac5e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2190-3	67296219003	30 TABLET in 1 BOTTLE (67296-2190-3)	30 tablet	2007-10-17	No	No	Current