Quick answers
- What is Solifenacin succinate used for?
- The FDA-approved label (Solifenacin succinate, HEC Pharm USA Inc., July 6, 2026) says: “Solifenacin succinate is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate is a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Solifenacin succinate have a boxed warning?
- The label we quote has no boxed warning, but 1 of 32 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Solifenacin succinate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Solifenacin succinate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 13, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Solifenacin succinate?
- 20 companies list prescription products of Solifenacin succinate in the FDA NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP and Alembic Pharmaceuticals Limited.
What Solifenacin succinate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Solifenacin succinate is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate is a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
— FDA label: Solifenacin succinate, HEC Pharm USA Inc., effective July 6, 2026. Read the full label on DailyMed →
The FDA has 32 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
1 of 32 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, coated · Tablet · Tablet, film coated, extended release |
|---|---|
| Route | Oral |
| Prescription products | 51 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| solifenacin succinate 10 mg tablet | Generic | $0.1466 per tablet |
| solifenacin succinate 10 mg tablet, coated | Generic | $0.1466 per tablet |
| solifenacin succinate 10 mg tablet, film coated | Generic | $0.1466 per tablet |
| solifenacin succinate 10 mg tablet, film coated, extended release | Generic | $0.1466 per tablet |
| solifenacin succinate 5 mg tablet | Generic | $0.1275 per tablet |
| solifenacin succinate 5 mg tablet, coated | Generic | $0.1275 per tablet |
| solifenacin succinate 5 mg tablet, film coated | Generic | $0.1275 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack10 products
- Proficient Rx LP6 products
- Alembic Pharmaceuticals Limited2 products
- Aurobindo Pharma Limited2 products
- HEC Pharm USA Inc.2 products
- Golden State Medical Supply, Inc.2 products
- Actavis Pharma, Inc.2 products
- Ajanta Pharma USA Inc.2 products
- Macleods Pharmaceuticals Limited2 products
- Ascend Laboratories, LLC2 products
- Unichem Pharmaceuticals (USA), Inc.2 products
- Bostal LLC2 products
- Alembic Pharmaceuticals Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- Apotex Corp.2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Novadoz Pharmaceuticals LLC2 products
- AvKARE2 products
- ScieGen Pharmaceuticals, Inc.2 products
- Qilu Pharmaceutical Co., Ltd.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (14)
- ANDA202551Watson Labs Inc · May 20, 2019
- ANDA205483Ajanta Pharma Ltd · May 20, 2019
- ANDA205575Alembic · May 20, 2019
- ANDA209239Glenmark Speclt · May 20, 2019
- ANDA209333Qilu · May 20, 2019
- ANDA210224Alkem Labs Ltd · May 20, 2019
- ANDA210281Bostal · May 20, 2019
- ANDA210688Msn · May 20, 2019
- ANDA211657Sciegen Pharms · May 20, 2019
- ANDA211701Unichem · August 27, 2019
- ANDA213346Sunshine · April 13, 2020
- ANDA215761Annora Pharma · June 15, 2022
- ANDA206817Aurobindo Pharma · December 27, 2022
- ANDA204374Macleods Pharms · February 20, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 13, 2025 · Class II · Ongoing · D-0333-2025
CGMP Deviations
Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Man — Glenmark Pharmaceuticals Inc., USA
-
March 13, 2025 · Class II · Ongoing · D-0317-2025
CGMP Deviations
Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manuf — Glenmark Pharmaceuticals Inc., USA
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 477367, 477372 |
|---|---|
| SPL set ID of the quoted label | 56026679-4002-a6c6-e063-6294a90a7b55 |
| FDA labels (SPL) | 32 |
| FDA applications | 14 ANDA |
| Active ingredients (FDA) | SOLIFENACIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Solifenacin succinate, HEC Pharm USA Inc., effective July 6, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →