Quick answers
- What is Darifenacin used for?
- The FDA-approved label (Darifenacin, Torrent Pharmaceuticals Limited, February 10, 2026) says: “Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Darifenacin extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Darifenacin have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Darifenacin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Darifenacin been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 15, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Darifenacin?
- 8 companies list prescription products of Darifenacin in the FDA NDC Directory, including Torrent Pharmaceuticals Limited, Rising Pharma Holdings, Inc. and Alembic Pharmaceuticals Limited.
What Darifenacin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Darifenacin extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
— FDA label: Darifenacin, Torrent Pharmaceuticals Limited, effective February 10, 2026. Read the full label on DailyMed →
The FDA has 9 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.
0 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, extended release · Tablet, film coated, extended release |
|---|---|
| Route | Oral |
| Prescription products | 16 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 |
|---|---|---|
| darifenacin hydrobromide 15 mg tablet, extended release | Generic | $0.4819 per tablet |
| darifenacin hydrobromide 15 mg tablet, film coated, extended release | Generic | $0.4819 per tablet |
| darifenacin hydrobromide 7.5 mg tablet, extended release | Generic | $0.5665 per tablet |
| darifenacin hydrobromide 7.5 mg tablet, film coated, extended release | Generic | $0.5665 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.
- Torrent Pharmaceuticals Limited2 products
- Rising Pharma Holdings, Inc.2 products
- Alembic Pharmaceuticals Limited2 products
- Macleods Pharmaceuticals Limited2 products
- Cipla USA Inc.2 products
- Bryant Ranch Prepack2 products
- Alembic Pharmaceuticals Inc.2 products
- Aurobindo Pharma Limited2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA207664Cipla · September 1, 2016
- ANDA206743Aurobindo Pharma · September 19, 2016
- ANDA205209Torrent · November 17, 2016
- ANDA207302Macleods Pharms · July 28, 2017
- ANDA207681Alembic · December 8, 2017
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 15, 2021 · Class II · Terminated · D-0584-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-203-30 — Cardinal Health Inc.
-
March 15, 2021 · Class II · Terminated · D-0583-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent Pharmaceuticals LTD. Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-202-30 — Cardinal Health Inc.
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) | 485421, 485423 |
|---|---|
| SPL set ID of the quoted label | e84f1ae3-b9a2-4a15-a299-c75373891cc1 |
| FDA labels (SPL) | 9 |
| FDA applications | 5 ANDA |
| Active ingredients (FDA) | DARIFENACIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Darifenacin, Torrent Pharmaceuticals Limited, effective February 10, 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 →