SOLIFENACIN SUCCINATE
- Product NDC
- 50228-427
- 11-digit product format
- 502280427
- Labeler code
- 50228
- Product ID
- 50228-427_b9432117-2521-7360-e053-2a95a90acd2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SOLIFENACIN SUCCINATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc.
- Application
- ANDA211657
- Marketing category
- ANDA
- Marketing start
- 2019-05-20
- 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 |
|---|
| 50228-427-05 | SOLIFENACIN SUCCINATE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 5 |
| 50228-427-30 | SOLIFENACIN SUCCINATE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 50228-427-90 | SOLIFENACIN SUCCINATE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-427 | SOLIFENACIN SUCCINATE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20210124_a6f154d9-7463-4b80-b80e-c06a06e36141.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 |
|---|
| 50228-427-05 | 50228042705 | 500 TABLET, FILM COATED in 1 BOTTLE (50228-427-05) | 2019-05-20 | 0000-00-00 | No | No | Current |
| 50228-427-30 | 50228042730 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-427-30) | 2019-05-20 | 0000-00-00 | No | No | Current |
| 50228-427-90 | 50228042790 | 90 TABLET, FILM COATED in 1 BOTTLE (50228-427-90) | 2019-05-20 | 0000-00-00 | No | No | Current |