Torsemide

Product NDC: 68084-539
11-digit product format: 680840539
Labeler code: 68084
Product ID: 68084-539_254ff01e-6c3e-2624-e063-6394a90a2ee3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Torsemide
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA079234
Marketing category: ANDA
Marketing start: 2011-10-19
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A079234-001	TORSEMIDE	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27
A079234-002	TORSEMIDE	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27
A079234-003	TORSEMIDE	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27
A079234-004	TORSEMIDE	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079234-001	AB
A079234-002	AB
A079234-003	AB
A079234-004	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	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079234-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079234-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079234-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2009-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079234-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2009-01-27	`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	A079234-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079234-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079234-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079234-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079234-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079234-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079234-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079234-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079234-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079234-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079234-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079234-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079234-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079234-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079234-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079234-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079234-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079234-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079234-004	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	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
aaabbaca-ba6f-42d5-980d-71135c7c80ea	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
68084-539-01	Torsemide	100 in 1 CARTON	TABLET	100		10
68084-539-11	Torsemide	1 in 1 BLISTER PACK	TABLET	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-539-01	EA - Each	68084-539	134b4dc0-28aa-4260-ba5a-7b91880bdcd3	1	2012-07-24
68084-539-11	EA - Each	68084-539	e7ffc2aa-7d2e-41fe-8f25-81715b76283b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TORSEMIDE	ACTIVE INGREDIENT	W31X2H97FB	TORSEMIDE TABLET [AMERICAN HEALTH PACKAGING]	5
TORSEMIDE	ACTIVE MOIETY	W31X2H97FB	TORSEMIDE TABLET [AMERICAN HEALTH PACKAGING]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TORSEMIDE TABLET [AMERICAN HEALTH PACKAGING]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	TORSEMIDE TABLET [AMERICAN HEALTH PACKAGING]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TORSEMIDE TABLET [AMERICAN HEALTH PACKAGING]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TORSEMIDE TABLET [AMERICAN HEALTH PACKAGING]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TORSEMIDE TABLET [AMERICAN HEALTH PACKAGING]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-539	TORSEMIDE TABLET [AMERICAN HEALTH PACKAGING]	10	Current NDC, Legacy NDC, 2 package rows	20241027_aaabbaca-ba6f-42d5-980d-71135c7c80ea.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Torsemide	TORSEMIDE	Major Pharmaceuticals	09305350-e317-419c-96f5-aa8fbeb4044d	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234
Torsemide	TORSEMIDE	AvPAK	f1439b9c-c01c-a6d4-594b-d92b8e0af26e	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234
TORSEMIDE	TORSEMIDE	Direct_Rx	91d45625-5ba6-b50f-e053-2a95a90ac314	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234
Torsemide	TORSEMIDE	A-S Medication Solutions	e58a7d1c-6584-44c3-98ce-a3e9b64e9c82	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234
Torsemide	TORSEMIDE	American Health Packaging	aaabbaca-ba6f-42d5-980d-71135c7c80ea	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234 ndc (product): 68084-539
Torsemide	TORSEMIDE	A-S Medication Solutions	05c8a6ee-9517-453f-8dd6-7e5ca83c5a68	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234
Torsemide	TORSEMIDE	XLCare Pharmaceuticals Inc.	234ff9d7-a02e-417f-a1f9-94038783cc77	2024-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234
Torsemide	TORSEMIDE	Bryant Ranch Prepack	f24151c8-02cd-4b07-a7fd-796903210aba	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234
Torsemide	TORSEMIDE	NCS HealthCare of KY, LLC dba Vangard Labs	201e892d-d963-4c6a-b35b-c5780b01f659	2022-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234
Torsemide	TORSEMIDE	Camber Pharmaceuticals, Inc.	0d4a4ef9-0944-452c-b014-bd822bfb9dd9	2017-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079234 application number: ANDA079234

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	aaabbaca-ba6f-42d5-980d-71135c7c80ea	10
198371	torsemide 20 MG Oral Tablet	SCD	aaabbaca-ba6f-42d5-980d-71135c7c80ea	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-539-01	68084053901	100 BLISTER PACK in 1 CARTON (68084-539-01) / 1 TABLET in 1 BLISTER PACK (68084-539-11)	100 blister pack	2011-10-19	0000-00-00	No	No	Current
68084-539-11	68084053911	1 in 1 BLISTER PACK						Historical