Solifenacin Succinate
- Product NDC
- 82804-044
- 11-digit product format
- 828040044
- Labeler code
- 82804
- Product ID
- 82804-044_8ab4f222-018f-40fc-a6aa-39dab563a8a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Solifenacin Succinate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA211701
- Marketing category
- ANDA
- Marketing start
- 2020-03-23
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-044-30 | Solifenacin Succinate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 82804-044-60 | Solifenacin Succinate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 82804-044-90 | Solifenacin Succinate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-044 | SOLIFENACIN SUCCINATE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | Current NDC, 3 package rows | 20231130_8ab4f222-018f-40fc-a6aa-39dab563a8a0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-044-30 | 82804004430 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-044-30) | 2023-11-28 | No | No | Current |
| 82804-044-60 | 82804004460 | 60 TABLET, FILM COATED in 1 BOTTLE (82804-044-60) | 2023-11-28 | No | No | Current |
| 82804-044-90 | 82804004490 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-044-90) | 2023-11-28 | No | No | Current |