Torsemide

Product NDC: 70518-2195
11-digit product format: 705182195
Labeler code: 70518
Product ID: 70518-2195_49dcd3b1-3175-b12b-e063-6294a90ac92c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Torsemide
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA076943
Marketing category: ANDA
Marketing start: 2019-07-09
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: 2027-12-31
Current FDA listing: Yes

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	70518-2195	70518-2195-0	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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2195-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2195-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2195-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2195-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2195-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2195-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2195-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2195-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2195-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2195-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2195-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2195-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076943-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076943-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076943-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076943-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076943-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076943-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076943-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076943-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076943-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076943-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076943-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076943-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076943-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076943-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076943-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076943-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076943-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076943-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076943-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076943-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076943-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076943-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076943-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076943-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076943-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076943-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076943-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076943-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076943-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076943-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076943-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076943-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076943-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076943-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076943-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076943-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076943-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076943-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076943-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076943-002	AB	1	`5c6f7cd8ea54…`

Additional Listing Data#

Finished product: Yes
Brand name base: Torsemide
Listing expiration: 2027-12-31

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
1c755d94-b846-4336-a968-aa1b92dc0ac0	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-03-08	These highlights do not include all the information needed to use TORSEMIDE TABLETS safely and effectively. See full prescribing information for TORSEMIDE TABLETS. TORSEMIDE tablets, for oral use Initial U.S. Approval: 1993
2023-03-08	These highlights do not include all the information needed to use TORSEMIDE TABLETS safely and effectively. See full prescribing information for TORSEMIDE TABLETS. TORSEMIDE tablets, for oral use Initial U.S. Approval: 1993
2023-01-30	These highlights do not include all the information needed to use TORSEMIDE TABLETS safely and effectively. See full prescribing information for TORSEMIDE TABLETS. TORSEMIDE tablets, for oral use Initial U.S. Approval: 1993
2023-01-30	These highlights do not include all the information needed to use TORSEMIDE TABLETS safely and effectively. See full prescribing information for TORSEMIDE TABLETS. TORSEMIDE tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-2195-0	Torsemide	90 in 1 BOTTLE, PLASTIC	TABLET	90		6
70518-2195-1	Torsemide	90 in 1 BOTTLE, PLASTIC	TABLET	90		6

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 ndc (product): 70518-2195
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
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

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	1c755d94-b846-4336-a968-aa1b92dc0ac0	6
198371	torsemide 20 MG Oral Tablet	SCD	1c755d94-b846-4336-a968-aa1b92dc0ac0	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2195-0	70518219500	90 TABLET in 1 BOTTLE, PLASTIC (70518-2195-0)	90 tablet	2019-07-09	0000-00-00	No	No	Current
70518-2195-1	70518219501	90 TABLET in 1 BOTTLE, PLASTIC (70518-2195-1)	90 tablet	2025-06-27		No	No	Current