Torsemide

Product NDC: 43353-315
Requested package NDC: 43353-315-16
11-digit product format: 433530315
Labeler code: 43353
Product ID: 43353-315_cd00a5cc-04b6-49cd-89d0-ae552b415f5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Torsemide
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076943
Marketing category: ANDA
Marketing start: 2005-03-03
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	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: 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
b869bc45-1ebb-42fb-82c5-603f09835790	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
43353-315-16	Torsemide	6000 in 1 BOTTLE, PLASTIC	TABLET	6000		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-315-16	EA - Each	43353-315	289e8f36-f48a-4557-853d-c4b7d1f52d5a	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-315	TORSEMIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Current NDC, Legacy NDC, 1 package rows	20171021_b869bc45-1ebb-42fb-82c5-603f09835790.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
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 ndc (package): 43353-315-16 ndc (product): 43353-315 ndc11 (package): 43353031516

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	b869bc45-1ebb-42fb-82c5-603f09835790	1
198371	torsemide 20 MG Oral Tablet	SCD	b869bc45-1ebb-42fb-82c5-603f09835790	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-315-16	43353031516	6000 TABLET in 1 BOTTLE, PLASTIC (43353-315-16)	6000 tablet	2017-05-03	0000-00-00	No	No	Current