Toviaz

Product NDC: 63539-183
Requested package NDC: 63539-183-77
11-digit product format: 635390183
Labeler code: 63539
Product ID: 63539-183_778882a1-fb9a-4405-96f9-18ea583085d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fesoterodine fumarate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: U.S. Pharmaceuticals
Application: NDA022030
Marketing category: NDA
Marketing start: 2008-10-31
Marketing end: 0000-00-00
Substance: FESOTERODINE FUMARATE
Active strength: 8 mg/1
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	63539-183	63539-183-77	D	Discontinued by firm		2026-09-09

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022030-001	TOVIAZ	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31
N022030-002	TOVIAZ	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022030-001	AB
N022030-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022030-001	7807715	2027-06-07	U-913	Drug product
N022030-001	8088398	2027-06-07	U-913	Drug product
N022030-001	8501723	2027-06-07		Drug product	2013-08-20
N022030-001	7807715*PED	2027-12-07		Pediatric extension
N022030-001	8088398*PED	2027-12-07		Pediatric extension
N022030-001	8501723*PED	2027-12-07		Pediatric extension
N022030-002	7807715	2027-06-07	U-913	Drug product
N022030-002	8088398	2027-06-07	U-913	Drug product
N022030-002	8501723	2027-06-07		Drug product	2013-08-20
N022030-002	7807715*PED	2027-12-07		Pediatric extension
N022030-002	8088398*PED	2027-12-07		Pediatric extension
N022030-002	8501723*PED	2027-12-07		Pediatric extension

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 · 84 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
2026-08-18 06:07:40	2026-07	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022030-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022030-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022030-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022030-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022030-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022030-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022030-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022030-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022030-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022030-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022030-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022030-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022030-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022030-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022030-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022030-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022030-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022030-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022030-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022030-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 556 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022030-001	7807715	2027-06-07	U-913	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-001	8088398	2027-06-07	U-913	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-001	8501723	2027-06-07		Drug product	2013-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-001	7807715*PED	2027-12-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-001	8088398*PED	2027-12-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-001	8501723*PED	2027-12-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	7807715	2027-06-07	U-913	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	8088398	2027-06-07	U-913	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	8501723	2027-06-07		Drug product	2013-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	7807715*PED	2027-12-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	8088398*PED	2027-12-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	8501723*PED	2027-12-07		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022030-001	7807715	2027-06-07	U-913	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-001	8088398	2027-06-07	U-913	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-001	8501723	2027-06-07		Drug product	2013-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-001	7807715*PED	2027-12-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-001	8088398*PED	2027-12-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-001	8501723*PED	2027-12-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	7807715	2027-06-07	U-913	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	8088398	2027-06-07	U-913	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	8501723	2027-06-07		Drug product	2013-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	7807715*PED	2027-12-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	8088398*PED	2027-12-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	8501723*PED	2027-12-07		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	7807715	2027-06-07	U-913	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	8088398	2027-06-07	U-913	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	8501723	2027-06-07		Drug product	2013-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	7807715*PED	2027-12-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	8088398*PED	2027-12-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	8501723*PED	2027-12-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	7807715	2027-06-07	U-913	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	8088398	2027-06-07	U-913	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	8501723	2027-06-07		Drug product	2013-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	7807715*PED	2027-12-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	8088398*PED	2027-12-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	8501723*PED	2027-12-07		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022030-001	7807715	2027-06-07	U-913	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022030-001	8088398	2027-06-07	U-913	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022030-001	8501723	2027-06-07		Drug product	2013-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022030-001	7807715*PED	2027-12-07		Pediatric extension		`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-001	I-861	2024-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-001	PED	2024-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-002	I-861	2024-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-002	PED	2024-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-001	I-861	2024-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-001	PED	2024-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-002	I-861	2024-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-002	PED	2024-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-001	I-861	2024-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-001	PED	2024-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-002	I-861	2024-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-002	PED	2024-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-001	I-861	2024-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-001	PED	2024-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-002	I-861	2024-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-002	PED	2024-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022030-001	I-861	2024-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022030-001	PED	2024-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022030-002	I-861	2024-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022030-002	PED	2024-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-001	I-861	2024-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-001	PED	2024-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-002	I-861	2024-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-002	PED	2024-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-001	I-861	2024-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-001	PED	2024-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-002	I-861	2024-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-002	PED	2024-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-001	I-861	2024-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-001	PED	2024-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-002	I-861	2024-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-002	PED	2024-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022030-001	I-861	2024-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022030-001	PED	2024-12-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022030-002	I-861	2024-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022030-002	PED	2024-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-001	I-861	2024-06-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-001	PED	2024-12-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-002	I-861	2024-06-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-002	PED	2024-12-17	`5c6f7cd8ea54…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63539-183-77	2024-01-30	C162847	48780-1	1030e365-1788-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use TOVIAZ safely and effectively. See full prescribing information for TOVIAZ. TOVIAZ ® (fesoterodine fumarate) extended-release tablets, for oral use Initial U.S. Approval: 2008

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FESOTERODINE FUMARATE	ACTIVE INGREDIENT	EOS72165S7	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	3
FESOTERODINE	ACTIVE MOIETY	621G617227	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	3
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	3
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	3
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	3
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63539-183	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	14	Legacy NDC	20241215_4f01dced-195a-4712-a614-d68012bc29df.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
Toviaz	FESOTERODINE FUMARATE	Pfizer Laboratories Div Pfizer Inc	5be745f0-8ae7-4c3c-9962-37d6263326f1	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022030 application number: NDA022030

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EOS72165S7	FESOTERODINE FUMARATE	286930-03-8	FESOTERODINE FUMARATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63539-183-77	63539018377	1 BLISTER PACK in 1 CARTON (63539-183-77) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2021-03-01	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Toviaz	U.S. Pharmaceuticals \| Pfizer Inc \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH \| Pfizer Laboratories Div Pfizer Inc \| Quinta-Analytica s.r.o.	2024-12-12	HUMAN PRESCRIPTION DRUG LABEL	14