Toviaz

Product NDC
0069-0242
11-digit product format
000690242
Labeler code
0069
Product ID
0069-0242_ca2031f1-5425-4d31-bf14-c865ec4e89b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fesoterodine fumarate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA022030
Marketing category
NDA
Marketing start
2008-10-31
Substance
FESOTERODINE FUMARATE
Active strength
4 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022030-001TOVIAZFESOTERODINE FUMARATE4MGTABLET, EXTENDED RELEASE / ORALABRLD2008-10-31
N022030-002TOVIAZFESOTERODINE FUMARATE8MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2008-10-31

Therapeutic equivalence codes#

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

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

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022030-00178077152027-06-07U-913Drug product
N022030-00180883982027-06-07U-913Drug product
N022030-00185017232027-06-07Drug product2013-08-20
N022030-0017807715*PED2027-12-07Pediatric extension
N022030-0018088398*PED2027-12-07Pediatric extension
N022030-0018501723*PED2027-12-07Pediatric extension
N022030-00278077152027-06-07U-913Drug product
N022030-00280883982027-06-07U-913Drug product
N022030-00285017232027-06-07Drug product2013-08-20
N022030-0027807715*PED2027-12-07Pediatric extension
N022030-0028088398*PED2027-12-07Pediatric extension
N022030-0028501723*PED2027-12-07Pediatric 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022030-001TOVIAZ4MGTABLET, EXTENDED RELEASE / ORALABRLD2008-10-31a50c72e98297…
2026-08-01 22:54:322026-06N022030-002TOVIAZ8MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2008-10-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022030-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N022030-002AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N022030-00178077152027-06-07U-913Drug producta50c72e98297…
2026-08-01 22:54:322026-06N022030-00180883982027-06-07U-913Drug producta50c72e98297…
2026-08-01 22:54:322026-06N022030-00185017232027-06-07Drug product2013-08-20a50c72e98297…
2026-08-01 22:54:322026-06N022030-0017807715*PED2027-12-07Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022030-0018088398*PED2027-12-07Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022030-0018501723*PED2027-12-07Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022030-00278077152027-06-07U-913Drug producta50c72e98297…
2026-08-01 22:54:322026-06N022030-00280883982027-06-07U-913Drug producta50c72e98297…
2026-08-01 22:54:322026-06N022030-00285017232027-06-07Drug product2013-08-20a50c72e98297…
2026-08-01 22:54:322026-06N022030-0027807715*PED2027-12-07Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022030-0028088398*PED2027-12-07Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022030-0028501723*PED2027-12-07Pediatric extensiona50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ToviazFESOTERODINE FUMARATEPfizer Laboratories Div Pfizer Inc5be745f0-8ae7-4c3c-9962-37d6263326f12026-04-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 022030
application number: NDA022030
ndc (product): 0069-0242

Additional Listing Data#

Finished product
Yes
Brand name base
Toviaz
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FESOTERODINE FUMARATE4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EOS72165S7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
810071Internal RxNorm lookup
810075Internal RxNorm lookup
810077Internal RxNorm lookup
810079Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5be745f0-8ae7-4c3c-9962-37d6263326f1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
929b9598-46e7-5b66-7a86-5544524fb173Product name620240208
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0242-30Toviaz30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0242-30EA - Each0069-02427beb37be-b5c7-43f0-b53b-7a582db41e7512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FESOTERODINE FUMARATEACTIVE INGREDIENTEOS72165S7TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19
FESOTERODINEACTIVE MOIETY621G617227TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19
TALCINACTIVE INGREDIENT7SEV7J4R1UTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ETOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]19
fesoterodine fumarateACTIVE INGREDIENTEOS72165S7TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
fesoterodineACTIVE MOIETY621G617227TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
aluminum oxideINACTIVE INGREDIENTLMI26O6933TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
glyceryl behenateINACTIVE INGREDIENTR8WTH25YS2TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
indigotindisulfonate sodiumINACTIVE INGREDIENTD3741U8K7LTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
lecithin, soybeanINACTIVE INGREDIENT1DI56QDM62TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ATOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
polyvinyl alcoholINACTIVE INGREDIENT532B59J990TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
talcINACTIVE INGREDIENT7SEV7J4R1UTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
xylitolINACTIVE INGREDIENTVCQ006KQ1ETOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
FESOTERODINE FUMARATEACTIVE INGREDIENTEOS72165S7TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]2
FESOTERODINEACTIVE MOIETY621G617227TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]2
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ETOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0242TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [PFIZER LABORATORIES DIV PFIZER INC]32Current NDC, Legacy NDC, 1 package rows20241215_5be745f0-8ae7-4c3c-9962-37d6263326f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
810071fesoterodine fumarate 4 MG 24HR Extended Release Oral TabletPSN5be745f0-8ae7-4c3c-9962-37d6263326f133
810077fesoterodine fumarate 8 MG 24HR Extended Release Oral TabletPSN5be745f0-8ae7-4c3c-9962-37d6263326f133
810075Toviaz 4 MG 24HR Extended Release Oral TabletPSN5be745f0-8ae7-4c3c-9962-37d6263326f133
810079Toviaz 8 MG 24HR Extended Release Oral TabletPSN5be745f0-8ae7-4c3c-9962-37d6263326f133
81007524 HR fesoterodine fumarate 4 MG Extended Release Oral Tablet [Toviaz]SBD5be745f0-8ae7-4c3c-9962-37d6263326f133
81007924 HR fesoterodine fumarate 8 MG Extended Release Oral Tablet [Toviaz]SBD5be745f0-8ae7-4c3c-9962-37d6263326f133
81007124 HR fesoterodine fumarate 4 MG Extended Release Oral TabletSCD5be745f0-8ae7-4c3c-9962-37d6263326f133
81007724 HR fesoterodine fumarate 8 MG Extended Release Oral TabletSCD5be745f0-8ae7-4c3c-9962-37d6263326f133
81007524 HR Toviaz 4 MG Extended Release Oral TabletSY5be745f0-8ae7-4c3c-9962-37d6263326f133
81007924 HR Toviaz 8 MG Extended Release Oral TabletSY5be745f0-8ae7-4c3c-9962-37d6263326f133
810071fesoterodine fumarate 4 MG 24 HR Extended Release Oral TabletSY5be745f0-8ae7-4c3c-9962-37d6263326f133
810077fesoterodine fumarate 8 MG 24 HR Extended Release Oral TabletSY5be745f0-8ae7-4c3c-9962-37d6263326f133
810075Toviaz 4 MG 24 HR Extended Release Oral TabletSY5be745f0-8ae7-4c3c-9962-37d6263326f133
810079Toviaz 8 MG 24 HR Extended Release Oral TabletSY5be745f0-8ae7-4c3c-9962-37d6263326f133
810071fesoterodine fumarate 4 MG 24HR Extended Release Oral TabletPSNfead426f-b955-4b41-8553-f102d17afa3a3
810077fesoterodine fumarate 8 MG 24HR Extended Release Oral TabletPSNfead426f-b955-4b41-8553-f102d17afa3a3
810075Toviaz 4 MG 24HR Extended Release Oral TabletPSNfead426f-b955-4b41-8553-f102d17afa3a3
810079Toviaz 8 MG 24HR Extended Release Oral TabletPSNfead426f-b955-4b41-8553-f102d17afa3a3
81007524 HR fesoterodine fumarate 4 MG Extended Release Oral Tablet [Toviaz]SBDfead426f-b955-4b41-8553-f102d17afa3a3
81007924 HR fesoterodine fumarate 8 MG Extended Release Oral Tablet [Toviaz]SBDfead426f-b955-4b41-8553-f102d17afa3a3
81007124 HR fesoterodine fumarate 4 MG Extended Release Oral TabletSCDfead426f-b955-4b41-8553-f102d17afa3a3
81007724 HR fesoterodine fumarate 8 MG Extended Release Oral TabletSCDfead426f-b955-4b41-8553-f102d17afa3a3
81007524 HR Toviaz 4 MG Extended Release Oral TabletSYfead426f-b955-4b41-8553-f102d17afa3a3
81007924 HR Toviaz 8 MG Extended Release Oral TabletSYfead426f-b955-4b41-8553-f102d17afa3a3
810071fesoterodine fumarate 4 MG 24 HR Extended Release Oral TabletSYfead426f-b955-4b41-8553-f102d17afa3a3
810077fesoterodine fumarate 8 MG 24 HR Extended Release Oral TabletSYfead426f-b955-4b41-8553-f102d17afa3a3
810075Toviaz 4 MG 24 HR Extended Release Oral TabletSYfead426f-b955-4b41-8553-f102d17afa3a3
810079Toviaz 8 MG 24 HR Extended Release Oral TabletSYfead426f-b955-4b41-8553-f102d17afa3a3
810071fesoterodine fumarate 4 MG 24HR Extended Release Oral TabletPSNf79a8796-a5b5-436e-8f94-f13a05eda63f1
810075Toviaz 4 MG 24HR Extended Release Oral TabletPSNf79a8796-a5b5-436e-8f94-f13a05eda63f1
81007524 HR fesoterodine fumarate 4 MG Extended Release Oral Tablet [Toviaz]SBDf79a8796-a5b5-436e-8f94-f13a05eda63f1
81007124 HR fesoterodine fumarate 4 MG Extended Release Oral TabletSCDf79a8796-a5b5-436e-8f94-f13a05eda63f1
81007524 HR Toviaz 4 MG Extended Release Oral TabletSYf79a8796-a5b5-436e-8f94-f13a05eda63f1
810071fesoterodine fumarate 4 MG 24 HR Extended Release Oral TabletSYf79a8796-a5b5-436e-8f94-f13a05eda63f1
810075Toviaz 4 MG 24 HR Extended Release Oral TabletSYf79a8796-a5b5-436e-8f94-f13a05eda63f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-0242-300006902423030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0242-30) 2008-10-310000-00-00NoNoCurrent