FDA.reportPublic FDA data

Toviaz

Product NDC
0069-0244
11-digit product format
000690244
Labeler code
0069
Product ID
0069-0244_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
8 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FESOTERODINE FUMARATE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEOS72165S7
Rxcui810071, 810075, 810077, 810079

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0069-0244-302024-01-30C16284748780-11030e365-5eae-111a-e063-dadaa90a10e2These 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0244-30Toviaz30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0244-30EA - Each0069-0244a599c5b3-b3c9-4935-b1d2-86976a66099612012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0244TOVIAZ (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
810077fesoterodine fumarate 8 MG 24HR Extended Release Oral TabletPSNe44e0f9d-6ff7-4a3d-995a-a2768bf9ac261
810079Toviaz 8 MG 24HR Extended Release Oral TabletPSNe44e0f9d-6ff7-4a3d-995a-a2768bf9ac261
81007924 HR fesoterodine fumarate 8 MG Extended Release Oral Tablet [Toviaz]SBDe44e0f9d-6ff7-4a3d-995a-a2768bf9ac261
81007724 HR fesoterodine fumarate 8 MG Extended Release Oral TabletSCDe44e0f9d-6ff7-4a3d-995a-a2768bf9ac261
81007924 HR Toviaz 8 MG Extended Release Oral TabletSYe44e0f9d-6ff7-4a3d-995a-a2768bf9ac261
810077fesoterodine fumarate 8 MG 24 HR Extended Release Oral TabletSYe44e0f9d-6ff7-4a3d-995a-a2768bf9ac261
810079Toviaz 8 MG 24 HR Extended Release Oral TabletSYe44e0f9d-6ff7-4a3d-995a-a2768bf9ac261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0069-0244-300006902443030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0244-30) 2008-10-310000-00-00NoNoCurrent