Torsemide

Product NDC: 62135-818
11-digit product format: 621350818
Labeler code: 62135
Product ID: 62135-818_459f249e-79f0-77db-e063-6294a90afda0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Torsemide
Dosage form: TABLET
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA076894
Marketing category: ANDA
Marketing start: 2005-05-31
Substance: TORSEMIDE
Active strength: 5 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
A076894-001	TORSEMIDE	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-05-31
A076894-002	TORSEMIDE	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-05-31
A076894-003	TORSEMIDE	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-05-31
A076894-004	TORSEMIDE	TORSEMIDE	100MG	TABLET / ORAL	AB	2005-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076894-001	AB
A076894-002	AB
A076894-003	AB
A076894-004	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	A076894-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076894-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076894-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076894-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2005-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076894-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076894-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076894-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076894-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2005-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076894-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076894-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076894-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076894-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2005-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076894-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076894-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076894-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076894-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2005-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076894-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076894-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076894-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076894-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2005-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076894-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076894-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076894-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076894-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2005-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076894-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076894-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076894-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076894-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2005-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076894-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076894-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076894-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076894-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2005-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076894-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076894-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076894-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076894-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2005-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076894-001	TORSEMIDE	5MG	TABLET / ORAL	AB	2005-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076894-002	TORSEMIDE	10MG	TABLET / ORAL	AB	2005-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076894-003	TORSEMIDE	20MG	TABLET / ORAL	AB	2005-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076894-004	TORSEMIDE	100MG	TABLET / ORAL	AB	2005-05-31	`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	A076894-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076894-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076894-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076894-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076894-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076894-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076894-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076894-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076894-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076894-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076894-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076894-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076894-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076894-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076894-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076894-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076894-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076894-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076894-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076894-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076894-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076894-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076894-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076894-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076894-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076894-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076894-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076894-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076894-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076894-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076894-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076894-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076894-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076894-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076894-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076894-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076894-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076894-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076894-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076894-004	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	5 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198369	Internal RxNorm lookup
198370	Internal RxNorm lookup
198371	Internal RxNorm lookup
198372	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
a3d68763-95e0-4ad6-89c2-c4b1c0b43948	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
62135-818-90	Torsemide	90 in 1 BOTTLE	TABLET	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-818-90	EA - Each	62135-818	87a66a6e-c8c1-4fd6-9b26-72483fcd8bbe	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-818	TORSEMIDE TABLET [CHARTWELL RX, LLC]	1	Current NDC, 1 package rows	20240202_a3d68763-95e0-4ad6-89c2-c4b1c0b43948.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Torsemide	TORSEMIDE	Chartwell RX, LLC	a3d68763-95e0-4ad6-89c2-c4b1c0b43948	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076894 application number: ANDA076894 ndc (product): 62135-818
Torsemide	TORSEMIDE	Bryant Ranch Prepack	0b3cfce4-61fc-42ba-9ea7-51f81ea014f7	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076894 application number: ANDA076894
Torsemide	TORSEMIDE	Bryant Ranch Prepack	e707eda7-4bde-4944-ae19-1b4fa35b6a3c	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076894 application number: ANDA076894
Torsemide	TORSEMIDE	REMEDYREPACK INC.	26a3af16-39fc-482d-8a8e-9473af4b0e3f	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076894 application number: ANDA076894
Torsemide	TORSEMIDE	Bryant Ranch Prepack	da8f2bf5-741c-45f6-b873-31a9fda2f880	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076894 application number: ANDA076894
Torsemide	TORSEMIDE	Bryant Ranch Prepack	16dfba29-4c26-45e7-ac7d-b2ec2058e2bb	2024-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076894 application number: ANDA076894
Torsemide	TORSEMIDE	Golden State Medical Supply, Inc.	2411e6f8-4fc3-f986-e063-6294a90a055a	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076894 application number: ANDA076894
Torsemide	TORSEMIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	03fbbb85-4e0f-4f3b-b4b0-87f84cb33d47	2023-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076894 application number: ANDA076894

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	a3d68763-95e0-4ad6-89c2-c4b1c0b43948	2
198370	torsemide 100 MG Oral Tablet	PSN	a3d68763-95e0-4ad6-89c2-c4b1c0b43948	2
198371	torsemide 20 MG Oral Tablet	PSN	a3d68763-95e0-4ad6-89c2-c4b1c0b43948	2
198372	torsemide 5 MG Oral Tablet	PSN	a3d68763-95e0-4ad6-89c2-c4b1c0b43948	2
198369	torsemide 10 MG Oral Tablet	SCD	a3d68763-95e0-4ad6-89c2-c4b1c0b43948	2
198370	torsemide 100 MG Oral Tablet	SCD	a3d68763-95e0-4ad6-89c2-c4b1c0b43948	2
198371	torsemide 20 MG Oral Tablet	SCD	a3d68763-95e0-4ad6-89c2-c4b1c0b43948	2
198372	torsemide 5 MG Oral Tablet	SCD	a3d68763-95e0-4ad6-89c2-c4b1c0b43948	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-818-90	62135081890	90 TABLET in 1 BOTTLE (62135-818-90)	90 tablet	2024-01-17	No	No	Current