Torsemide

Product NDC: 0615-8521
11-digit product format: 006158521
Labeler code: 0615
Product ID: 0615-8521_3ccef263-cd0f-4935-83a2-9b43a609e94a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Torsemide
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA076346
Marketing category: ANDA
Marketing start: 2004-06-01
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
A076346-001	TORSEMIDE	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30
A076346-002	TORSEMIDE	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30
A076346-003	TORSEMIDE	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30
A076346-004	TORSEMIDE	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A076346-001	AB
A076346-002	AB
A076346-003	AB
A076346-004	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076346-001	TORSEMIDE	5MG	TABLET / ORAL	AB		2003-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076346-002	TORSEMIDE	10MG	TABLET / ORAL	AB		2003-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076346-003	TORSEMIDE	20MG	TABLET / ORAL	AB	RS	2003-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076346-004	TORSEMIDE	100MG	TABLET / ORAL	AB		2004-10-19	`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	A076346-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076346-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076346-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076346-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076346-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076346-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076346-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076346-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076346-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076346-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076346-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076346-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076346-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076346-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076346-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076346-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076346-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076346-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076346-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076346-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076346-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076346-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076346-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076346-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076346-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076346-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076346-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076346-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076346-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076346-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076346-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076346-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076346-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076346-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076346-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076346-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076346-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076346-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076346-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076346-004	AB	1	`d06236e962d9…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198369	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
99b537f3-1fbf-48b7-ac3e-0a43e6aab313	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
0615-8521-39	Torsemide	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8521	TORSEMIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	1	Current NDC, 1 package rows	20241027_99b537f3-1fbf-48b7-ac3e-0a43e6aab313.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	AvKARE	7fc14338-92e4-cf57-a3e8-ef64d8d1026c	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076346 application number: ANDA076346
Torsemide	TORSEMIDE	NCS HealthCare of KY, LLC dba Vangard Labs	99b537f3-1fbf-48b7-ac3e-0a43e6aab313	2024-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076346 application number: ANDA076346 ndc (product): 0615-8521
Torsemide	TORSEMIDE	A-S Medication Solutions	3e9c6ee1-c49f-4f59-9391-8a9b57becb02	2023-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076346 application number: ANDA076346
Torsemide	TORSEMIDE	A-S Medication Solutions	3ed913ba-f0c0-4ba5-9440-73c4374f4226	2023-05-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076346 application number: ANDA076346
Torsemide	TORSEMIDE	Teva Pharmaceuticals USA, Inc.	8a95cbdb-0601-47a5-9b3a-0c3b0629ceb9	2017-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076346 application number: ANDA076346

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
198369	torsemide 10 MG Oral Tablet	PSN	99b537f3-1fbf-48b7-ac3e-0a43e6aab313	1
198369	torsemide 10 MG Oral Tablet	SCD	99b537f3-1fbf-48b7-ac3e-0a43e6aab313	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0615-8521-39	00615852139	30 TABLET in 1 BLISTER PACK (0615-8521-39)	30 tablet	2024-08-12	No	No	Current