Solifenacin succinate
- Product NDC
- 82804-058
- 11-digit product format
- 828040058
- Labeler code
- 82804
- Product ID
- 82804-058_b20003a6-f781-4563-9824-3e8b97c763c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- solifenacin succinate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202551
- Marketing category
- ANDA
- Marketing start
- 2020-04-09
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| KKA5DLD701 | SOLIFENACIN SUCCINATE | 242478-38-2 | SOLIFENACIN SUCCINATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-058-30 | 82804005830 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-058-30) | 2024-01-15 | No | No | Historical |
| 82804-058-60 | 82804005860 | 60 TABLET, FILM COATED in 1 BOTTLE (82804-058-60) | 2024-01-15 | No | No | Historical |
| 82804-058-90 | 82804005890 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-058-90) | 2024-01-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Solifenacin succinate | Proficient Rx LP | 2024-01-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |