solifenacin succinate
- Product NDC
- 33342-149
- 11-digit product format
- 333420149
- Labeler code
- 33342
- Product ID
- 33342-149_fbd6e753-1ed2-418a-8667-c674b215eabb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- solifenacin succinate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA204374
- Marketing category
- ANDA
- Marketing start
- 2024-02-20
- 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
- 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 | 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 |
|---|
| 33342-149-07 | solifenacin succinate | 30 in 1 CONTAINER | TABLET, COATED | 30 | | 1 |
| 33342-149-10 | solifenacin succinate | 90 in 1 CONTAINER | TABLET, COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-149 | SOLIFENACIN SUCCINATE TABLET, COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | Current NDC, 2 package rows | 20240308_fbd6e753-1ed2-418a-8667-c674b215eabb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 33342-149-07 | 33342014907 | 30 TABLET, COATED in 1 CONTAINER (33342-149-07) | 2024-02-20 | No | No | Historical |
| 33342-149-10 | 33342014910 | 90 TABLET, COATED in 1 CONTAINER (33342-149-10) | 2024-02-20 | No | No | Historical |