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
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| N022030-001 | AB |
| N022030-002 | AB |
Orange Book patents#
| 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 | 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 | 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 | 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.
| 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 | 022030 NDA022030 0069-0242 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Toviaz
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FESOTERODINE FUMARATE | 4 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| EOS72165S7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5be745f0-8ae7-4c3c-9962-37d6263326f1 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 929b9598-46e7-5b66-7a86-5544524fb173 | Product name | 6 | 20240208 |
| 351abe41-466c-4dd8-840a-0fdb68318bd5 | Product name | 1 | 20230316 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0069-0242-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5eae-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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0069-0242-30 | Toviaz | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | 33 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0069-0242-30 | EA - Each | 0069-0242 | 7beb37be-b5c7-43f0-b53b-7a582db41e75 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 810071 | fesoterodine fumarate 4 MG 24HR Extended Release Oral Tablet | PSN | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 33 |
| 810077 | fesoterodine fumarate 8 MG 24HR Extended Release Oral Tablet | PSN | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 33 |
| 810075 | Toviaz 4 MG 24HR Extended Release Oral Tablet | PSN | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 33 |
| 810079 | Toviaz 8 MG 24HR Extended Release Oral Tablet | PSN | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 33 |
| 810075 | 24 HR fesoterodine fumarate 4 MG Extended Release Oral Tablet [Toviaz] | SBD | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 33 |
| 810079 | 24 HR fesoterodine fumarate 8 MG Extended Release Oral Tablet [Toviaz] | SBD | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 33 |
| 810071 | 24 HR fesoterodine fumarate 4 MG Extended Release Oral Tablet | SCD | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 33 |
| 810077 | 24 HR fesoterodine fumarate 8 MG Extended Release Oral Tablet | SCD | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 33 |
| 810075 | 24 HR Toviaz 4 MG Extended Release Oral Tablet | SY | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 33 |
| 810079 | 24 HR Toviaz 8 MG Extended Release Oral Tablet | SY | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 33 |
| 810071 | fesoterodine fumarate 4 MG 24 HR Extended Release Oral Tablet | SY | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 33 |
| 810077 | fesoterodine fumarate 8 MG 24 HR Extended Release Oral Tablet | SY | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 33 |
| 810075 | Toviaz 4 MG 24 HR Extended Release Oral Tablet | SY | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 33 |
| 810079 | Toviaz 8 MG 24 HR Extended Release Oral Tablet | SY | 5be745f0-8ae7-4c3c-9962-37d6263326f1 | 33 |
| 810071 | fesoterodine fumarate 4 MG 24HR Extended Release Oral Tablet | PSN | fead426f-b955-4b41-8553-f102d17afa3a | 3 |
| 810077 | fesoterodine fumarate 8 MG 24HR Extended Release Oral Tablet | PSN | fead426f-b955-4b41-8553-f102d17afa3a | 3 |
| 810075 | Toviaz 4 MG 24HR Extended Release Oral Tablet | PSN | fead426f-b955-4b41-8553-f102d17afa3a | 3 |
| 810079 | Toviaz 8 MG 24HR Extended Release Oral Tablet | PSN | fead426f-b955-4b41-8553-f102d17afa3a | 3 |
| 810075 | 24 HR fesoterodine fumarate 4 MG Extended Release Oral Tablet [Toviaz] | SBD | fead426f-b955-4b41-8553-f102d17afa3a | 3 |
| 810079 | 24 HR fesoterodine fumarate 8 MG Extended Release Oral Tablet [Toviaz] | SBD | fead426f-b955-4b41-8553-f102d17afa3a | 3 |
| 810071 | 24 HR fesoterodine fumarate 4 MG Extended Release Oral Tablet | SCD | fead426f-b955-4b41-8553-f102d17afa3a | 3 |
| 810077 | 24 HR fesoterodine fumarate 8 MG Extended Release Oral Tablet | SCD | fead426f-b955-4b41-8553-f102d17afa3a | 3 |
| 810075 | 24 HR Toviaz 4 MG Extended Release Oral Tablet | SY | fead426f-b955-4b41-8553-f102d17afa3a | 3 |
| 810079 | 24 HR Toviaz 8 MG Extended Release Oral Tablet | SY | fead426f-b955-4b41-8553-f102d17afa3a | 3 |
| 810071 | fesoterodine fumarate 4 MG 24 HR Extended Release Oral Tablet | SY | fead426f-b955-4b41-8553-f102d17afa3a | 3 |
| 810077 | fesoterodine fumarate 8 MG 24 HR Extended Release Oral Tablet | SY | fead426f-b955-4b41-8553-f102d17afa3a | 3 |
| 810075 | Toviaz 4 MG 24 HR Extended Release Oral Tablet | SY | fead426f-b955-4b41-8553-f102d17afa3a | 3 |
| 810079 | Toviaz 8 MG 24 HR Extended Release Oral Tablet | SY | fead426f-b955-4b41-8553-f102d17afa3a | 3 |
| 810071 | fesoterodine fumarate 4 MG 24HR Extended Release Oral Tablet | PSN | f79a8796-a5b5-436e-8f94-f13a05eda63f | 1 |
| 810075 | Toviaz 4 MG 24HR Extended Release Oral Tablet | PSN | f79a8796-a5b5-436e-8f94-f13a05eda63f | 1 |
| 810075 | 24 HR fesoterodine fumarate 4 MG Extended Release Oral Tablet [Toviaz] | SBD | f79a8796-a5b5-436e-8f94-f13a05eda63f | 1 |
| 810071 | 24 HR fesoterodine fumarate 4 MG Extended Release Oral Tablet | SCD | f79a8796-a5b5-436e-8f94-f13a05eda63f | 1 |
| 810075 | 24 HR Toviaz 4 MG Extended Release Oral Tablet | SY | f79a8796-a5b5-436e-8f94-f13a05eda63f | 1 |
| 810071 | fesoterodine fumarate 4 MG 24 HR Extended Release Oral Tablet | SY | f79a8796-a5b5-436e-8f94-f13a05eda63f | 1 |
| 810075 | Toviaz 4 MG 24 HR Extended Release Oral Tablet | SY | f79a8796-a5b5-436e-8f94-f13a05eda63f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0069-0242-30 | 00069024230 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0242-30) | 2008-10-31 | 0000-00-00 | No | No | Current |