fesoterodine fumarate
- Product NDC
- 68382-479
- 11-digit product format
- 683820479
- Labeler code
- 68382
- Product ID
- 68382-479_3e1e7df1-1de5-4500-bcd3-1c9ae36a60d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fesoterodine fumarate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA204946
- Marketing category
- ANDA
- Marketing start
- 2017-12-07
- Substance
- FESOTERODINE FUMARATE
- Active strength
- 4 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- fesoterodine fumarate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FESOTERODINE FUMARATE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EOS72165S7 |
| Rxcui | 810071, 810077 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-479-06 | fesoterodine fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 7 |
| 68382-479-16 | fesoterodine fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 7 |
| 68382-479-30 | fesoterodine fumarate | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 7 |
| 68382-479-77 | fesoterodine fumarate | 10 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-479 | FESOTERODINE FUMARATE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20250104_8c68e918-b47b-466d-80bc-4f521aa74607.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-479-06 | 68382047906 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-479-06) | | 2017-12-07 | 0000-00-00 | No | No | Current |
| 68382-479-16 | 68382047916 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-479-16) | | 2017-12-07 | 0000-00-00 | No | No | Current |
| 68382-479-30 | 68382047930 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68382-479-77 | 68382047977 | 10 BLISTER PACK in 1 CARTON (68382-479-77) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-479-30) | 10 blister pack | 2017-12-07 | 0000-00-00 | No | No | Current |