Home NDC 69189-0242 Toviaz
Product NDC 69189-0242
11-digit product format 691890242
Labeler code 69189
Product ID 69189-0242_9461c993-f972-4bbb-882b-904034f10236
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fesoterodine fumarate
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Avera McKennan Hospital
Application NDA022030
Marketing category NDA
Marketing start 2015-04-01
Marketing end 0000-00-00
Substance FESOTERODINE FUMARATE
Active strength 4 mg/1
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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.
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
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69189-0242-1 Toviaz 1 in 1 DOSE PACK TABLET, FILM COATED, EXTENDED RE 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69189-0242 TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [AVERA MCKENNAN HOSPITAL] 1 Legacy NDC, 1 package rows 20151222_f79a8796-a5b5-436e-8f94-f13a05eda63f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 69189-0242-1 69189024201 1 in 1 DOSE PACK Historical