SOAANZ

Product NDC: 73502-287
Requested package NDC: 73502-287-16
11-digit product format: 735020287
Labeler code: 73502
Product ID: 73502-287_ea38eccd-bb2d-4cfb-9f63-6e0052d4aaff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Torsemide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sarfez Pharmaceuticals Inc
Application: NDA213218
Marketing category: NDA
Marketing start: 2022-01-24
Marketing end: 0000-00-00
Substance: TORSEMIDE
Active strength: 40 mg/1
Pharmacologic classes: Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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	73502-287	73502-287-16	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
N213218-001	SOAANZ	TORSEMIDE	20MG	TABLET / ORAL	RLD	2021-06-14
N213218-002	SOAANZ	TORSEMIDE	60MG	TABLET / ORAL	RLD	2021-06-14
N213218-003	SOAANZ	TORSEMIDE	40MG	TABLET / ORAL	RLD	2021-11-17

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213218-001	10154963	2033-10-06		Drug product	2021-09-07
N213218-002	10154963	2033-10-06		Drug product	2021-09-07

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 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213218-001	SOAANZ	20MG	TABLET / ORAL	RLD	2021-06-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213218-002	SOAANZ	60MG	TABLET / ORAL	RLD	2021-06-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213218-003	SOAANZ	40MG	TABLET / ORAL	RLD	2021-11-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213218-001	SOAANZ	20MG	TABLET / ORAL	RLD	2021-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213218-002	SOAANZ	60MG	TABLET / ORAL	RLD	2021-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213218-003	SOAANZ	40MG	TABLET / ORAL	RLD	2021-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213218-001	SOAANZ	20MG	TABLET / ORAL	RLD	2021-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213218-002	SOAANZ	60MG	TABLET / ORAL	RLD	2021-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213218-003	SOAANZ	40MG	TABLET / ORAL	RLD	2021-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213218-001	SOAANZ	20MG	TABLET / ORAL	RLD	2021-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213218-002	SOAANZ	60MG	TABLET / ORAL	RLD	2021-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213218-003	SOAANZ	40MG	TABLET / ORAL	RLD	2021-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213218-001	SOAANZ	20MG	TABLET / ORAL	RLD	2021-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213218-002	SOAANZ	60MG	TABLET / ORAL	RLD	2021-06-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213218-003	SOAANZ	40MG	TABLET / ORAL	RLD	2021-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213218-001	SOAANZ	20MG	TABLET / ORAL	RLD	2021-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213218-002	SOAANZ	60MG	TABLET / ORAL	RLD	2021-06-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213218-003	SOAANZ	40MG	TABLET / ORAL	RLD	2021-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213218-001	SOAANZ	20MG	TABLET / ORAL	RLD	2021-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213218-002	SOAANZ	60MG	TABLET / ORAL	RLD	2021-06-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213218-003	SOAANZ	40MG	TABLET / ORAL	RLD	2021-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213218-001	SOAANZ	20MG	TABLET / ORAL	RLD	2021-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213218-002	SOAANZ	60MG	TABLET / ORAL	RLD	2021-06-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213218-003	SOAANZ	40MG	TABLET / ORAL	RLD	2021-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213218-001	SOAANZ	20MG	TABLET / ORAL	RLD	2021-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213218-002	SOAANZ	60MG	TABLET / ORAL	RLD	2021-06-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213218-003	SOAANZ	40MG	TABLET / ORAL	RLD	2021-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213218-001	SOAANZ	20MG	TABLET / ORAL	RLD	2021-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213218-002	SOAANZ	60MG	TABLET / ORAL	RLD	2021-06-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213218-003	SOAANZ	40MG	TABLET / ORAL	RLD	2021-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213218-001	SOAANZ	20MG	TABLET / ORAL	RLD	2021-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213218-002	SOAANZ	60MG	TABLET / ORAL	RLD	2021-06-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213218-003	SOAANZ	40MG	TABLET / ORAL	RLD	2021-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213218-001	SOAANZ	20MG	TABLET / ORAL	RLD	2021-06-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213218-002	SOAANZ	60MG	TABLET / ORAL	RLD	2021-06-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213218-003	SOAANZ	40MG	TABLET / ORAL	RLD	2021-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213218-001	SOAANZ	20MG	TABLET / ORAL	RLD	2021-06-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213218-002	SOAANZ	60MG	TABLET / ORAL	RLD	2021-06-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213218-003	SOAANZ	40MG	TABLET / ORAL	RLD	2021-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213218-001	SOAANZ	20MG	TABLET / ORAL	RLD	2021-06-14	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213218-001	10154963	2033-10-06	Drug product	2021-09-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213218-002	10154963	2033-10-06	Drug product	2021-09-07	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
73502-287-12	SOAANZ	6 in 1 BLISTER PACK	TABLET, FILM COATED	6		4
73502-287-16	SOAANZ	5 in 1 CARTON	TABLET, FILM COATED	5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73502-287	SOAANZ (TORSEMIDE) TABLET, FILM COATED [SARFEZ PHARMACEUTICALS INC]	3	Legacy NDC, 2 package rows	20240119_05eaa163-b6e9-438a-85f8-6a60e743d460.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOAANZ	TORSEMIDE	Sarfez Pharmaceuticals Inc	05eaa163-b6e9-438a-85f8-6a60e743d460	2026-01-09		Exact identifier application applno (NDA): 213218 application number: NDA213218 ndc (package): 73502-287-16 ndc (product): 73502-287 ndc11 (package): 73502028716

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
2589877	SOAANZ 20 MG Oral Tablet	PSN	05eaa163-b6e9-438a-85f8-6a60e743d460	4
2589883	SOAANZ 40 MG Oral Tablet	PSN	05eaa163-b6e9-438a-85f8-6a60e743d460	4
2589887	SOAANZ 60 MG Oral Tablet	PSN	05eaa163-b6e9-438a-85f8-6a60e743d460	4
198371	torsemide 20 MG Oral Tablet	PSN	05eaa163-b6e9-438a-85f8-6a60e743d460	4
2589881	torsemide 40 MG Oral Tablet	PSN	05eaa163-b6e9-438a-85f8-6a60e743d460	4
2589885	torsemide 60 MG Oral Tablet	PSN	05eaa163-b6e9-438a-85f8-6a60e743d460	4
2589877	torsemide 20 MG Oral Tablet [Soaanz]	SBD	05eaa163-b6e9-438a-85f8-6a60e743d460	4
2589883	torsemide 40 MG Oral Tablet [Soaanz]	SBD	05eaa163-b6e9-438a-85f8-6a60e743d460	4
2589887	torsemide 60 MG Oral Tablet [Soaanz]	SBD	05eaa163-b6e9-438a-85f8-6a60e743d460	4
198371	torsemide 20 MG Oral Tablet	SCD	05eaa163-b6e9-438a-85f8-6a60e743d460	4
2589881	torsemide 40 MG Oral Tablet	SCD	05eaa163-b6e9-438a-85f8-6a60e743d460	4
2589885	torsemide 60 MG Oral Tablet	SCD	05eaa163-b6e9-438a-85f8-6a60e743d460	4
2589877	Soaanz 20 MG Oral Tablet	SY	05eaa163-b6e9-438a-85f8-6a60e743d460	4
2589883	Soaanz 40 MG Oral Tablet	SY	05eaa163-b6e9-438a-85f8-6a60e743d460	4
2589887	Soaanz 60 MG Oral Tablet	SY	05eaa163-b6e9-438a-85f8-6a60e743d460	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73502-287-16	73502028716	5 BLISTER PACK in 1 CARTON (73502-287-16) > 6 TABLET, FILM COATED in 1 BLISTER PACK (73502-287-12)	5 blister pack	2022-01-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SOAANZ - Sarfez Pharmaceuticals Inc	Sarfez Pharmaceuticals Inc	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL	4