Solifenacin succinate
- Product NDC
- 0591-3795
- 11-digit product format
- 005913795
- Labeler code
- 0591
- Product ID
- 0591-3795_4a8ad4ea-e579-4269-b16d-fdc627ba1114
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- solifenacin succinate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA202551
- Marketing category
- ANDA
- Marketing start
- 2020-06-30
- 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 |
|---|
| 0591-3795-19 | Solifenacin succinate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 17 |
| 0591-3795-30 | Solifenacin succinate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-3795 | SOLIFENACIN SUCCINATE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20250417_02e2aa54-1ed8-445a-a082-ac2c64b339fe.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 |
|---|
| 0591-3795-19 | 00591379519 | 90 TABLET, FILM COATED in 1 BOTTLE (0591-3795-19) | 2020-06-30 | 0000-00-00 | No | No | Current |
| 0591-3795-30 | 00591379530 | 30 TABLET, FILM COATED in 1 BOTTLE (0591-3795-30) | 2023-01-23 | | No | No | Historical |