Toviaz

Product NDC: 63539-242
11-digit product format: 635390242
Labeler code: 63539
Product ID: 63539-242_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: 4 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63539-242		D	Discontinued by firm		2026-07-31
excluded package	package	63539-242	63539-242-77	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

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
2026-08-01 22:54:32	2026-06	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N022030-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022030-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N022030-001	7807715	2027-06-07	U-913	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022030-001	8088398	2027-06-07	U-913	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022030-001	8501723	2027-06-07		Drug product	2013-08-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022030-001	7807715*PED	2027-12-07		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022030-001	8088398*PED	2027-12-07		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022030-001	8501723*PED	2027-12-07		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022030-002	7807715	2027-06-07	U-913	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022030-002	8088398	2027-06-07	U-913	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022030-002	8501723	2027-06-07		Drug product	2013-08-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022030-002	7807715*PED	2027-12-07		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022030-002	8088398*PED	2027-12-07		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022030-002	8501723*PED	2027-12-07		Pediatric extension		`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63539-242-77	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
63539-242	TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS]	14	Legacy NDC	20241215_4f01dced-195a-4712-a614-d68012bc29df.zip

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
63539-242-05	63539024205	5 BLISTER PACK in 1 CARTON (63539-242-05) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (63539-242-03)	5 blister pack	2008-10-31	2021-08-31	Yes	No	Current
63539-242-77	63539024277	1 BLISTER PACK in 1 CARTON (63539-242-77) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	1 blister pack	2021-05-03	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