Solifenacin Succinate
- Product NDC
- 65862-878
- 11-digit product format
- 658620878
- Labeler code
- 65862
- Product ID
- 65862-878_ececaabb-2b01-4ef5-b5e8-a927478deccc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Solifenacin Succinate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA206817
- Marketing category
- ANDA
- Marketing start
- 2022-12-27
- Substance
- SOLIFENACIN SUCCINATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Solifenacin Succinate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOLIFENACIN SUCCINATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KKA5DLD701 |
| Rxcui | 477367, 477372 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-878-03 | Solifenacin Succinate | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 3 |
| 65862-878-10 | Solifenacin Succinate | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 3 |
| 65862-878-30 | Solifenacin Succinate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 65862-878-90 | Solifenacin Succinate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
| 65862-878-99 | Solifenacin Succinate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-878 | SOLIFENACIN SUCCINATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 3 | Current NDC, Legacy NDC, 5 package rows | 20240510_92b37f2d-b1cf-49e6-a13b-0ead92c0604c.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 |
|---|
| 65862-878-03 | 65862087803 | 3 BLISTER PACK in 1 CARTON (65862-878-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-878-10) | 3 blister pack | 2022-12-27 | 0000-00-00 | No | No | Current |
| 65862-878-10 | 65862087810 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 65862-878-30 | 65862087830 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-878-30) | | 2022-12-27 | 0000-00-00 | No | No | Current |
| 65862-878-90 | 65862087890 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-878-90) | | 2022-12-27 | 0000-00-00 | No | No | Current |
| 65862-878-99 | 65862087899 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-878-99) | | 2022-12-27 | 0000-00-00 | No | No | Current |