Toviaz
- Product NDC
- 63539-183
- 11-digit product format
- 635390183
- Labeler code
- 63539
- Product ID
- 63539-183_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
- 8 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| 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 |
|---|
| 63539-183 | TOVIAZ (FESOTERODINE FUMARATE) TABLET, FILM COATED, EXTENDED RELEASE [U.S. PHARMACEUTICALS] | 14 | Legacy NDC | 20241215_4f01dced-195a-4712-a614-d68012bc29df.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63539-183-05 | 63539018305 | 5 BLISTER PACK in 1 CARTON (63539-183-05) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (63539-183-03) | 5 blister pack | 2008-10-31 | 2021-07-31 | Yes | No | Current |
| 63539-183-77 | 63539018377 | 1 BLISTER PACK in 1 CARTON (63539-183-77) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2021-03-01 | 0000-00-00 | Yes | No | Current |