FESOTERODINE FUMARATE
- Product NDC
- 65862-767
- 11-digit product format
- 658620767
- Labeler code
- 65862
- Product ID
- 65862-767_33d91059-f2d5-482f-a47f-b1dccb7c5b22
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FESOTERODINE FUMARATE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA205007
- Marketing category
- ANDA
- Marketing start
- 2022-06-17
- Substance
- FESOTERODINE FUMARATE
- Active strength
- 8 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 | 8 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 |
|---|
| 65862-767-30 | FESOTERODINE FUMARATE | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-767 | FESOTERODINE FUMARATE TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241222_dc8f6158-3c2b-4ec0-a951-e04468b83bb1.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 |
|---|
| 65862-767-30 | 65862076730 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-767-30) | 2022-06-17 | 0000-00-00 | No | No | Current |