fesoterodine fumarate
- Product NDC
- 70771-1168
- 11-digit product format
- 707711168
- Labeler code
- 70771
- Product ID
- 70771-1168_5b9a792a-f173-43f9-917a-af99185196e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fesoterodine fumarate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- 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 |
|---|
| 70771-1168-2 | fesoterodine fumarate | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 5 |
| 70771-1168-3 | fesoterodine fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 5 |
| 70771-1168-4 | fesoterodine fumarate | 10 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 10 | | 5 |
| 70771-1168-9 | fesoterodine fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1168 | FESOTERODINE FUMARATE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED] | 5 | Current NDC, Legacy NDC, 4 package rows | 20241201_26e8cc63-1e1d-4a77-8f53-4c38bcf0d443.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 |
|---|
| 70771-1168-2 | 70771116802 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 70771-1168-3 | 70771116803 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1168-3) | | 2017-12-07 | 0000-00-00 | No | No | Current |
| 70771-1168-4 | 70771116804 | 10 BLISTER PACK in 1 CARTON (70771-1168-4) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70771-1168-2) | 10 blister pack | 2017-12-07 | 0000-00-00 | No | No | Current |
| 70771-1168-9 | 70771116809 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1168-9) | | 2017-12-07 | 0000-00-00 | No | No | Current |