Fesoterodine Fumarate
- Product NDC
- 65162-369
- 11-digit product format
- 651620369
- Labeler code
- 65162
- Product ID
- 65162-369_84a0cad7-6b3b-46f3-8797-c0b922026154
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fesoterodine Fumarate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA205002
- Marketing category
- ANDA
- Marketing start
- 2023-01-06
- 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 |
|---|
| 65162-369-03 | Fesoterodine Fumarate | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 12 |
| 65162-369-09 | Fesoterodine Fumarate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-369 | FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240514_1d3fdfcf-7406-4be0-90e9-b10c9257bf69.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-369-03 | 65162036903 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-369-03) | 2023-01-06 | 0000-00-00 | No | No | Current |
| 65162-369-09 | 65162036909 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-369-09) | 2023-01-06 | 0000-00-00 | No | No | Current |