Prescription and over-the-counter medicine
Oxybutynin Brand names: Oxytrol; first approved as Ditropan
Oxybutynin (Ditropan) is a prescription and over-the-counter medicine with an FDA approval on record since 1975. FDA's NDC Directory lists it from 39 generic labelers, and pharmacies paid $0.048 per oxybutynin 5 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $2.74 per unit (Oxytrol for women 3.9 mg/24hr).
- Generic listed
Check it at the source: the oxybutynin FDA label on DailyMed (effective December 16, 2025, Accord Healthcare, Inc.); the NDA 17577 record on Drugs@FDA; every oxybutynin label on DailyMed.
Highlights of the record
FDA label of December 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageOxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Forms and strengths
- 2.5 mg
- 3.9 mg
- 5 mg
- 10 mg
- 15 mg
- 5 mg/5ml
Extended-release tablet; tablet; film-coated extended-release tablet; syrup; patch.
On the market
- Earliest approval on file
- July 16, 1975 Ditropan, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 33 first November 14, 1988; 23 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 40 of which 39 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 26, 2031 Gelnique gel; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.048 per tablet Oxybutynin 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 9 since 2013 0 Class I among all firms' recalls; latest October 19, 2023
- FAERS reports
- 37,662 through July 30, 2026
What is oxybutynin used for?
From the label: indications and usageOxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). Oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. […]
Conditions named in the indications of oxybutynin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Cholinergic Muscarinic Antagonist.
Source: FDA drug label (oxybutynin chloride), Accord Healthcare, Inc., effective December 16, 2025 (SPL set 61496a1e-17bf-4f45-a20c-5bb98fe545ee), via openFDA; the full label on DailyMed
What does the patient leaflet for oxybutynin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using OXYTROL?You should not drink alcohol while using OXYTROL. Drinking alcohol can increase drowsiness that results from OXYTROL use. • OXYTROL can cause dizziness or blurred vision. Do not drive, operate machinery, or do other dangerous activities until you know how OXYTROL affects you. • Do not put OXYTROL on areas that have been treated with oils, lotions, or powders that could keep the patch from sticking well to your skin. Do not expose the patch to sunlight. Wear your patch under clothing. • Avoid rubbing the patch area during bathing, swimming, showering or exercising.
From the patient leaflet: How should I store OXYTROL?Store OXYTROL at room temperature between 68°F to 77°F (20°C to 25°C). • Do not store OXYTROL outside the sealed pouch. • Keep OXYTROL patches in a dry place. • Safely throw away used OXYTROL patches in the household trash. Be careful to prevent accidental exposure of OXYTROL to children or pets. Keep OXYTROL and all medicines out of the reach of children.
Source: FDA drug label (OXYTROL), Allergan, Inc., effective May 29, 2024 (SPL set 20dee37f-1412-44ed-9e8b-f4379ce23eb0), via openFDA; the full label on DailyMed
Is there a generic for oxybutynin (Ditropan)?
The FDA approved the first generic oxybutynin on November 14, 1988. 33 generic applications are approved; 23 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists oxybutynin from 39 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Ditropan XL tablets; a patent listed only for Gelnique gel runs to March 26, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1975 earliest approval on file
- 1988 first generic approved
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for oxybutynin (Ditropan)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.048 per Oxybutynin 5 mg tablet, down 2% from $0.0492 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Oxybutynin 5 mg tablet (generic)
- Oxytrol for women 3.9 mg/24hr (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Oxybutynin 2.5 mg tablet | Generic | $1.97 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $58.98 | -7% |
| Oxybutynin 5 mg tablet | Generic | $0.048 per tablet | $1.44 | -2% |
| Oxybutynin 5 mg/5 mL solution | Generic | $0.0327 per mL | n/a | +2% |
| Oxybutynin 5 mg/5 mL syrup | Generic | $0.0327 per mL | n/a | +2% |
| Oxybutynin cl ER 10 mg tablet | Generic | $0.0997 per tablet | $2.99 | -5% |
| Oxybutynin cl ER 15 mg tablet | Generic | $0.125 per tablet | $3.75 | -1% |
| Oxybutynin cl ER 5 mg tablet | Generic | $0.0841 per tablet | $2.52 | -15% |
| Oxytrol 3.9 mg/24hr patch | Brand | $81.29 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +0.4% |
| Oxytrol for women 3.9 mg/24hr | Brand | $2.74 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +0.9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has oxybutynin been recalled?
The FDA's Enforcement Report lists 9 recalls naming oxybutynin since 2013: 0 Class I (the most serious), 7 Class II, 2 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 19, 2023 | Class II | Zydus Pharmaceuticals (USA) Inc | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. |
| September 21, 2023 | Class II | Zydus Pharmaceuticals (USA) Inc | Failed Dissolution Specifications |
| March 1, 2019 | Class III | AVKARE Inc. | Failed Dissolution Specifications |
| February 21, 2019 | Class III | Lannett Company Inc. | Failed Dissolution Specifications |
| December 11, 2018 | Class II | KVK-Tech, Inc. | Labeling: Wrong bar code |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg) may have potentially been mislabeled as the following drug: PIMOZIDE, Tablet, 1 mg … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 100 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the oxybutynin label say about other medicines?
The oxybutynin label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name oxybutynin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Clarithromycin | drug interactions | Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C max and AUC). |
| Erythromycin | drug interactions | Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C max and AUC). |
| Itraconazole | drug interactions | Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C max and AUC). |
| Ketoconazole | drug interactions | Mean oxybutynin plasma concentrations were approximately 2 fold higher when oxybutynin chloride extended-release tablet was administered with ketoconazole, a potent CYP3A4 inhibitor. |
| Metoclopramide | drug interactions | Anticholinergic agents may also antagonize the effects of prokinetic agents, such as metoclopramide. |
| Miconazole | drug interactions | Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C max and AUC). |
Other labels that name oxybutynin
Source: FDA drug label (oxybutynin chloride), Accord Healthcare, Inc., effective December 16, 2025 (SPL set 61496a1e-17bf-4f45-a20c-5bb98fe545ee), via openFDA; the full label on DailyMed
What do FAERS reports show for oxybutynin?
The FDA Adverse Event Reporting System holds 37,662 reports that list oxybutynin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,238 are coded as a death and 9,373 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as oxybutynin?
7 other medicines are given the same way (oral) and in the same FDA class as oxybutynin or labeled mainly for the same use (overactive bladder), the same class first. Overactive bladder lists all 9 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Solifenacin | Overactive bladder | 20 labelers | $0.162 per tablet 10 mg tablet | No current entry |
| Tolterodine | Overactive bladder | 14 labelers | $0.268 per capsule 2 mg capsule | No current entry |
| Trospium | Overactive bladder | 20 labelers | $0.211 per tablet 20 mg tablet | No current entry |
| Darifenacin | Overactive bladder | 8 labelers | $0.432 per tablet 15 mg tablet | No current entry |
| Fesoterodine | Overactive bladder | 11 labelers | $0.794 per tablet 4 mg tablet | No current entry |
| Mirabegron | Overactive bladder | 8 labelers | $9.39 per tablet 50 mg tablet | No current entry |
| Vibegron | Overactive bladder | none listed | $16.46 per tablet 75 mg tablet | No current entry |
Every medicine labeled for the same conditions as oxybutynin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does oxybutynin compare with medicines for the same use?
5 side-by-side pages set oxybutynin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to oxybutynin
- 7 medicines for the same use
- Other cholinergic muscarinic antagonists
- the pharmacologic class, with prices and generics
- Oxybutynin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other