Solifenacin Succinate
- Product NDC
- 35561-286
- 11-digit product format
- 355610286
- Labeler code
- 35561
- Product ID
- 35561-286_49fcc8a4-31aa-6975-e063-6394a90a9389
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- solifenacin succinate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bostal LLC
- Application
- ANDA210281
- Marketing category
- ANDA
- Marketing start
- 2019-05-20
- Substance
- SOLIFENACIN SUCCINATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Solifenacin Succinate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOLIFENACIN SUCCINATE | 10 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 |
|---|
| 35561-286-00 | Solifenacin Succinate | 129032 in 1 BOX | TABLET, FILM COATED | 129032 | | 10 |
| 35561-286-10 | Solifenacin Succinate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 10 |
| 35561-286-11 | Solifenacin Succinate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 10 |
| 35561-286-13 | Solifenacin Succinate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35561-286 | SOLIFENACIN SUCCINATE (SOLIFENACIN SUCCIATE) TABLET, FILM COATED SOLIFENACIN SUCCINATE TABLET, FILM COATED [AUSTARPHARMA LLC] | 9 | Current NDC, Legacy NDC, 4 package rows | 20250331_d155c739-6870-4938-ba91-8c1b4b90afe4.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 |
|---|
| 35561-286-00 | 35561028600 | 129032 TABLET, FILM COATED in 1 BOX (35561-286-00) | 2019-05-20 | | No | No | Historical |
| 35561-286-10 | 35561028610 | 30 TABLET, FILM COATED in 1 BOTTLE (35561-286-10) | 2019-05-20 | 0000-00-00 | No | No | Current |
| 35561-286-11 | 35561028611 | 90 TABLET, FILM COATED in 1 BOTTLE (35561-286-11) | 2019-05-20 | 0000-00-00 | No | No | Current |
| 35561-286-13 | 35561028613 | 500 TABLET, FILM COATED in 1 BOTTLE (35561-286-13) | 2019-05-20 | 0000-00-00 | No | No | Current |