Quick answers
- What is Oxybutynin used for?
- The FDA-approved label (Oxytrol, Allergan, Inc., May 29, 2024) says: “OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency. OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men 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 Oxybutynin have a boxed warning?
- No. None of the 82 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Oxybutynin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Oxybutynin been recalled?
- FDA enforcement reports list 7 recalls of products of this medicine; the newest started October 19, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Oxybutynin?
- 40 companies list prescription products of Oxybutynin in the FDA NDC Directory, including A-S Medication Solutions, Aphena Pharma Solutions - Tennessee, LLC and Bryant Ranch Prepack.
What Oxybutynin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency. OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency.
— FDA label: Oxytrol, Allergan, Inc., effective May 29, 2024. Read the full label on DailyMed →
The FDA has 82 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 82 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, extended release · Tablet · Tablet, film coated, extended release · Syrup · Solution · Patch |
|---|---|
| Route | Oral · Transdermal |
| Prescription products | 116 in the FDA NDC Directory |
| Brand names | Oxytrol |
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 |
|---|---|---|
| oxybutynin 3.9 mg/d patch | Brand: Oxytrol | $81.20 per patch |
| oxybutynin chloride 10 mg tablet, extended release | Generic | $0.1001 per tablet |
| oxybutynin chloride 10 mg tablet, film coated, extended release | Generic | $0.1001 per tablet |
| oxybutynin chloride 15 mg tablet, extended release | Generic | $0.1287 per tablet |
| oxybutynin chloride 15 mg tablet, film coated, extended release | Generic | $0.1287 per tablet |
| oxybutynin chloride 2.5 mg tablet | Generic | $1.82 per tablet |
| oxybutynin chloride 5 mg tablet | Generic | $0.0488 per tablet |
| oxybutynin chloride 5 mg tablet, extended release | Generic | $0.0854 per tablet |
| oxybutynin chloride 5 mg tablet, film coated, extended release | Generic | $0.0854 per tablet |
| oxybutynin chloride 5 mg/5 mL solution | Generic | $0.0330 per mL |
| oxybutynin chloride 5 mg/5 mL syrup | Generic | $0.0330 per mL |
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.
- A-S Medication Solutions12 products
- Aphena Pharma Solutions - Tennessee, LLC8 products
- Bryant Ranch Prepack7 products
- PD-Rx Pharmaceuticals, Inc.7 products
- Rising Pharma Holdings, Inc.7 products
- Lannett Company, Inc.4 products
- Chartwell RX, LLC4 products
- AvKARE4 products
- Direct_Rx3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- American Health Packaging3 products
- Proficient Rx LP3 products
- Accord Healthcare Inc.3 products
- Ajanta Pharma USA Inc.3 products
- Coupler LLC3 products
- AvPAK3 products
- Amneal Pharmaceuticals LLC3 products
- Advagen Pharma Limited3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Zydus Lifesciences Limited3 products
- Strides Pharma Science Limited3 products
- Major Pharmaceuticals2 products
- Redpharm Drug2 products
- TruPharma, LLC2 products
- Northwind Health Company, LLC2 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2 products
- Atlantic Biologicals Corp.1 product
- Cardinal Health 107, LLC1 product
- Preferred Pharmaceuticals Inc.1 product
- Chartwell Governmental & Specialty RX, LLC.1 product
- Leading Pharma, LLC1 product
- ANI Pharmaceuticals, Inc.1 product
- Remedyrepack Inc.1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Verityrx, LLC1 product
- Upsher-Smith Laboratories, LLC1 product
- KVK-Tech, Inc.1 product
- Golden State Medical Supply, Inc.1 product
- NuCare Pharmaceuticals, Inc.1 product
- Allergan, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021351 OXYTROL | Allergan | February 26, 2003 | 14, latest May 29, 2024 2024: Labeling · 2017: Labeling · 2017: Labeling |
Generic approvals (19)
- ANDA071655Teva Pharms USA · November 14, 1988
- ANDA074520Lannett Co Inc · March 29, 1996
- ANDA074625Aiping Pharm Inc · July 31, 1996
- ANDA075079Strides Pharma Intl · October 31, 1997
- ANDA075039Chartwell Rx · January 29, 1999
- ANDA078503Osmotica Pharm Us · February 4, 2009
- ANDA204010Amneal Pharms · November 23, 2015
- ANDA207138Accord Hlthcare · February 29, 2016
- ANDA206121Unique · May 27, 2016
- ANDA202332Zydus Pharms · June 26, 2017
- ANDA209823Novitium Pharma · October 23, 2017
- ANDA209025Rising · December 21, 2017
- ANDA209335Abhai LLC · December 22, 2017
- ANDA210125Tp Anda Holdings · September 6, 2018
- ANDA211655Ajanta Pharma Ltd · February 28, 2019
- ANDA211682Heritage Pharma Avet · May 10, 2019
- ANDA212798Leading · April 6, 2020
- ANDA214415Rubicon Research · October 27, 2020
- ANDA208165Strides Pharma · December 17, 2020
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.
-
October 19, 2023 · Class II · Completed · D-0097-2024
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01. — Zydus Pharmaceuticals (USA) Inc
-
October 19, 2023 · Class II · Completed · D-0098-2024
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01. — Zydus Pharmaceuticals (USA) Inc
-
October 19, 2023 · Class II · Completed · D-0096-2024
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01 — Zydus Pharmaceuticals (USA) Inc
-
September 21, 2023 · Class II · Terminated · D-0038-2024
Failed Dissolution Specifications
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: — Zydus Pharmaceuticals (USA) Inc
-
March 1, 2019 · Class III · Terminated · D-0990-2019
Failed Dissolution Specifications
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 — AVKARE Inc.
-
February 21, 2019 · Class III · Terminated · D-0996-2019
Failed Dissolution Specifications
Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37 — Lannett Company Inc.
-
December 11, 2018 · Class II · Terminated · D-0340-2019
Labeling: Wrong bar code
Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50 — KVK-Tech, 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Oxytrol, Allergan, Inc., effective May 29, 2024; 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 →