Solifenacin Succinate
- Product NDC
- 46708-192
- 11-digit product format
- 467080192
- Labeler code
- 46708
- Product ID
- 46708-192_aea71cde-6d62-4f8d-b813-47064cb213d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Solifenacin Succinate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA205575
- 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 |
|---|
| 46708-192-08 | Solifenacin Succinate | 80 in 1 CARTON | TABLET, COATED | 80 | | 1 |
| 46708-192-30 | Solifenacin Succinate | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 1 |
| 46708-192-90 | Solifenacin Succinate | 90 in 1 BOTTLE | TABLET, COATED | 90 | | 1 |
| 46708-192-91 | Solifenacin Succinate | 1000 in 1 BOTTLE | TABLET, COATED | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-192 | SOLIFENACIN SUCCINATE TABLET, COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, Legacy NDC, 4 package rows | 20190523_aea71cde-6d62-4f8d-b813-47064cb213d9.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 |
|---|
| 46708-192-08 | 46708019208 | 80 TABLET, COATED in 1 CARTON (46708-192-08) | 2019-05-20 | 0000-00-00 | No | No | Current |
| 46708-192-30 | 46708019230 | 30 TABLET, COATED in 1 BOTTLE (46708-192-30) | 2019-05-20 | 0000-00-00 | No | No | Current |
| 46708-192-90 | 46708019290 | 90 TABLET, COATED in 1 BOTTLE (46708-192-90) | 2019-05-20 | 0000-00-00 | No | No | Current |
| 46708-192-91 | 46708019291 | 1000 TABLET, COATED in 1 BOTTLE (46708-192-91) | 2019-05-20 | 0000-00-00 | No | No | Current |