Oxybutynin Chloride
Tablet, Extended Release · Oral
Uses
Oxybutynin chloride tablets are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).
Dosage and administration
Adults The usual dose is one 5-mg tablet two to three times a day. The maximum recommended dose is one 5-mg tablet four times a day. A lower starting dose of 2.5 mg two or three times a day is recommended for the frail elderly. Pediatric patients over 5 years of age The usual dose is one 5-mg tablet two times a day. The maximum recommended dose is one 5-mg tablet three times a day. Adults The usual dose is one 5-mg tablet two to three times a day. The maximum recommended dose is one 5-mg tablet four times a day. A lower starting dose of 2.5 mg two or three times a day is recommended for the frail elderly. Pediatric patients over 5 years of age The usual dose is one 5-mg tablet two times a day. The maximum recommended dose is one 5-mg tablet three times a day.
Contraindications
Oxybutynin chloride is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. Oxybutynin chloride is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.
Warnings
Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.
Precautions
Central Nervous System Effects Oxybutynin is associated with anticholinergic central nervous system (CNS) effects (see ADVERSE REACTIONS ). A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. Oxybutynin chloride should be used with caution in patients with pre-existing dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms. Oxybutynin chloride should be used with caution in patients with Parkinson's disease due to the risk of aggravation of symptoms. General Oxybutynin chloride should be used with caution in the frail elderly, in patients with hepatic or renal impairment, and in patients with myasthenia gravis. Oxybutynin chloride may aggravate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hiatal hernia, tachycardia, hypertension, myasthenia gravis, and prostatic hypertrophy. Urinary Retention Oxybutynin chloride should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention (see CONTRAINDICATIONS ). Gastrointestinal Disorders Oxybutynin chloride should be used with caution in patients with autonomic neuropathy due to the risk of aggravation of symptoms of decreased gastrointestinal motility. Oxybutynin chloride should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention (see CONTRAINDICATIONS ). Administration of oxybutynin chloride to patients with ulcerative colitis may suppress intestinal motility to the point of producing a paralytic ileus and precipitate or aggravate toxic megacolon, a serious complication of the disease. Oxybutynin chloride, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, and intestinal atony. Oxybutynin chloride should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis. Information for Patients Patients should be informed that oxybutynin may produce angioedema that could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing. Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin chloride are administered in the presence of high environmental temperature. Because anticholinergic agents such as oxybutynin may produce drowsiness (somnolence), or blurred vision, patients should be advised to exercise caution. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin. Drug Interactions The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a narrow therapeutic index. Anticholinergic agents may also antagonize the effects of the prokinetic agents, such as metoclopramide. Mean oxybutynin chloride plasma concentrations were approximately 3 to 4 fold higher when oxybutynin chloride was administered with ketoconazole, a potent CYP3A4 inhibitor. 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). The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are co-administered. Carcinogenesis, Mutagenesis, Impairment of Fertility A 24-month study in rats at dosages of oxybutynin chloride of 20, 80, and 160 mg/kg/day showed no evidence of carcinogenicity. These doses are approximately 6, 25, and 50 times the maximum human exposure, based on surface area. Oxybutynin chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae and Salmonella typhimurium test systems. Reproduction studies using oxybutynin chloride in the hamster, rabbit, rat, and mouse have shown no definite evidence of impaired fertility. Pregnancy Category B. Reproduction studies using oxybutynin chloride in the hamster, rabbit, rat, and mouse have shown no definite evidence of impaired fertility or harm to the animal fetus. The safety of oxybutynin chloride administered to women who are or who may become pregnant has not been established. Therefore, oxybutynin chloride should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when oxybutynin chloride is administered to a nursing woman. Pediatric Use The safety and efficacy of oxybutynin chloride administration have been demonstrated for pediatric patients 5 years of age and older (see DOSAGE AND ADMINISTRATION ).
Side effects
The safety and efficacy of oxybutynin chloride was evaluated in a total of 199 patients in three clinical trials. These participants were treated with oxybutynin chloride 5 to 20 mg/day for up to 6 weeks. Table 3 shows the incidence of adverse events judged by investigators to be at least possibly related to treatment and reported by at least 5% of patients. The most common adverse events reported by patients receiving oxybutynin chloride 5 to 20 mg/day were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related. In addition, the following adverse events were reported by 1 to < 5% of patients using oxybutynin chloride (5 to 20 mg/day) in all studies. Infections and Infestations: nasopharyngitis, upper respiratory tract infection, bronchitis, cystitis, fungal infection; Metabolism and Nutrition Disorders: fluid retention; Psychiatric Disorders: confusional state; Nervous System Disorders: dysgeusia, sinus headache; Eye Disorders: keratoconjunctivitis sicca, eye irritation; Cardiac Disorders: palpitations, sinus arrhythmia; Vascular Disorders: flushing; Respiratory, Thoracic and Mediastinal Disorders: nasal dryness, cough, pharyngolaryngeal pain, dry throat, sinus congestion, hoarseness, asthma, nasal congestion; Gastrointestinal Disorders: diarrhea, abdominal pain, loose stools, flatulence, vomiting, abdominal pain upper, dysphagia, aptyalism, eructation, tongue coated; Skin and Subcutaneous Tissue Disorders: dry skin, pruritis; Musculoskeletal and Connective Tissue Disorders: back pain, arthralgia, pain in extremity, flank pain; Renal and Urinary Disorders: dysuria, pollakiuria; General Disorders and Administration Site Conditions: fatigue, edema peripheral, asthenia, pain, thirst, edema; Investigations: blood pressure increased, blood glucose increased, blood pressure decreased; Injury, Poisoning, and Procedural Complications: fall. table3 Postmarketing Surveillance Because postmarketing adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following additional adverse events have been reported from worldwide postmarketing experience with oral oxybutynin chloride: Psychiatric Disorders: psychotic disorder, agitation, hallucinations, memory impairment; Nervous System Disorders: convulsions; Eye Disorders: cycloplegia, mydriasis, glaucoma; Cardiac Disorders: tachycardia, QT interval prolongation, chest discomfort; Gastrointestinal Disorders: decreased gastrointestinal motility, frequent bowel movements; Skin and Subcutaneous Tissue Disorders: rash, decreased sweating; Renal and Urinary Disorders: impotence; Reproductive System and Breast Disorders: suppression of lactation; General Disorders and Administration Site Conditions: hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; rare anaphylactic reactions requiring hospitalization for emergency treatment; Metabolism and Nutrition Disorders: anorexia; Respiratory, Thoracic and Mediastinal Disorders: dysphonia. To report SUSPECTED ADVERSE REACTIONS, contact TruPharma LLC at 1-877-541-5504 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug interactions
Drug Interactions The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a narrow therapeutic index. Anticholinergic agents may also antagonize the effects of the prokinetic agents, such as metoclopramide. Mean oxybutynin chloride plasma concentrations were approximately 3 to 4 fold higher when oxybutynin chloride was administered with ketoconazole, a potent CYP3A4 inhibitor. 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). The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are co-administered.
Pregnancy
Pregnancy Category B. Reproduction studies using oxybutynin chloride in the hamster, rabbit, rat, and mouse have shown no definite evidence of impaired fertility or harm to the animal fetus. The safety of oxybutynin chloride administered to women who are or who may become pregnant has not been established. Therefore, oxybutynin chloride should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards. Category B. Reproduction studies using oxybutynin chloride in the hamster, rabbit, rat, and mouse have shown no definite evidence of impaired fertility or harm to the animal fetus. The safety of oxybutynin chloride administered to women who are or who may become pregnant has not been established. Therefore, oxybutynin chloride should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards.
Pediatric use
Pediatric Use The safety and efficacy of oxybutynin chloride administration have been demonstrated for pediatric patients 5 years of age and older (see DOSAGE AND ADMINISTRATION ). The safety and efficacy of oxybutynin chloride tablets were studied in 30 children in a 24-week, open-label trial. Patients were aged 5 to 15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride. Study results demonstrated that the administration of oxybutynin chloride was associated with improvement in clinical and urodynamic parameters. At total daily doses ranging from 5 mg to 15 mg, treatment with oxybutynin chloride tablets was associated with an increase from baseline in mean urine volume per catheterization from 122 mL to 145 mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 168 mL, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 43% to 61%. Urodynamic results in these patients were consistent with the clinical results. Treatment with oxybutynin chloride tablets was associated with an increase from baseline in maximum cystometric capacity from 230 mL to 279 mL, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 36 cm H 2 O to 33 cm H 2 O, and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H 2 O) from 39% to 20%. As there is insufficient clinical data for pediatric populations under age 5, oxybutynin chloride is not recommended for this age group.
Geriatric use
Geriatric Use Clinical studies of oxybutynin chloride did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between healthy elderly and younger patients; however, a lower initial starting dose of 2.5 mg given 2 or 3 times a day has been recommended for the frail elderly due to a prolongation of the elimination half-life from 2 to 3 hours to 5 hours. 2,3,4 In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Overdosage
Treatment should be symptomatic and supportive. Activated charcoal as well as a cathartic may be administered. Overdosage with oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation (e.g., restlessness, tremor, irritability, convulsions, delirium, hallucinations), flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Other symptoms may include hypotension or hypertension, respiratory failure, paralysis, and coma. Ingestion of 100 mg oxybutynin chloride in association with alcohol has been reported in a 13 year old boy who experienced memory loss, and a 34 year old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients fully recovered with symptomatic treatment.
Description
Each oxybutynin chloride tablet contains 2.5mg and 5mg of oxybutynin chloride.. Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C 22 H 31 NO 3
• HCl. The structural formula appears below: Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.95. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin Chloride Tablets also contain colloidal silicon dioxide NF, FD&C Blue #1 aluminum lake, magnesium stearate NF, microcrystalline cellulose NF, and pregelatinized starch NF. Oxybutynin Chloride Tablets are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic. Oxybutynin Chloride Tablets conform to USP Dissolution Test 2. This is an image of the structural formula for Oxybutynin Chloride.
How supplied
Oxybutynin Chloride Tablets USP, 5 mg, are round, blue, scored tablets debossed "5" and "T" on one side separated by a vertical score and plain on the reverse side. The tablets are supplied as follows: Bottles of 100: NDC 52817-260-10 Bottles of 500: NDC 52817-260-50 Oxybutynin Chloride Tablets USP, 2.5 mg, are round, blue, debossed "1" and "T" on one side and plain on the reverse side. The tablets are supplied as follows:
• Bottles of 100: NDC 52817-261-10
Storage
Pharmacist: Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Patient information
Information for Patients Patients should be informed that oxybutynin may produce angioedema that could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing. Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin chloride are administered in the presence of high environmental temperature. Because anticholinergic agents such as oxybutynin may produce drowsiness (somnolence), or blurred vision, patients should be advised to exercise caution. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin.
Label text from the FDA structured product label by TruPharma LLC (revised Jul 27, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Oxybutynin Chloride in 105 products
Oxybutynin Chloride NDC products (105)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-8078 | Oxybutynin Chloride 5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-4307 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-4622 | Oxybutynin Chloride 5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5822 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-6199 | Oxybutynin Chloride 5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6638 | Oxybutynin Chloride 5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6673 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-6840 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | A-S Medication Solutions | ANDA |
| 50090-6966 | Oxybutynin Chloride 5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6967 | Oxybutynin Chloride 5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7766 | Oxybutynin Chloride 5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 16729-319 | Oxybutynin Chloride 15 mg/1 Tablet, Extended Release | Accord Healthcare, Inc. | ANDA |
| 16729-318 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | Accord Healthcare, Inc. | ANDA |
| 16729-317 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | Accord Healthcare, Inc. | ANDA |
| 72888-032 | Oxybutynin Chloride 15 mg/1 Tablet, Extended Release | Advagen Pharma Limited | ANDA |
| 72888-030 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | Advagen Pharma Limited | ANDA |
| 72888-031 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | Advagen Pharma Limited | ANDA |
| 27241-155 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | Ajanta Pharma USA Inc. | ANDA |
| 27241-156 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | Ajanta Pharma USA Inc. | ANDA |
| 27241-157 | Oxybutynin Chloride 15 mg/1 Tablet, Extended Release | Ajanta Pharma USA Inc. | ANDA |
| 68084-610 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | American Health Packaging | ANDA |
| 60687-899 | Oxybutynin Chloride 5 mg/1 Tablet | American Health Packaging | ANDA |
| 68084-480 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | American Health Packaging | ANDA |
| 65162-371 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | Amneal Pharmaceuticals LLC | ANDA |
| 65162-373 | Oxybutynin Chloride 15 mg/1 Tablet, Extended Release | Amneal Pharmaceuticals LLC | ANDA |
| 65162-372 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | Amneal Pharmaceuticals LLC | ANDA |
| 70954-005 | Oxybutynin Chloride 5 mg/1 Tablet | ANI Pharmaceuticals, Inc. | ANDA |
| 43353-978 | Oxybutynin Chloride 5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-322 | Oxybutynin Chloride 15 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-285 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-284 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-282 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-277 | Oxybutynin Chloride 5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-394 | Oxybutynin Chloride 5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-860 | Oxybutynin Chloride 5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 17856-0149 | Oxybutynin Chloride 5 mg/5mL Syrup | ATLANTIC BIOLOGICALS CORP. | ANDA |
| 42291-456 | Oxybutynin Chloride 5 mg/1 Tablet | AvKARE | ANDA |
| 42291-633 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | AvKARE | ANDA |
| 42291-634 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | AvKARE | ANDA |
| 42291-635 | Oxybutynin Chloride 15 mg/1 Tablet, Extended Release | AvKARE | ANDA |
| 50268-627 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | AvPAK | ANDA |
| 50268-629 | Oxybutynin Chloride 15 mg/1 Tablet, Extended Release | AvPAK | ANDA |
| 50268-628 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | AvPAK | ANDA |
| 71335-2121 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-2330 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 63629-9689 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-1690 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | Bryant Ranch Prepack | ANDA |
| 71335-1494 | Oxybutynin Chloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1014 | Oxybutynin Chloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0519 | Oxybutynin Chloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 55154-2632 | Oxybutynin Chloride 5 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 68999-520 | Oxybutynin Chloride 5 mg/5mL Solution | Chartwell Governmental & Specialty RX, LLC. | ANDA |
| 62135-508 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | Chartwell RX, LLC | ANDA |
| 62135-509 | Oxybutynin Chloride 15 mg/1 Tablet, Extended Release | Chartwell RX, LLC | ANDA |
| 62135-520 | Oxybutynin Chloride 5 mg/5mL Solution | Chartwell RX, LLC | ANDA |
| 62135-507 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | Chartwell RX, LLC | ANDA |
| 67046-1599 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | Coupler LLC | ANDA |
| 67046-1381 | Oxybutynin Chloride 5 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-1600 | Oxybutynin Chloride 15 mg/1 Tablet, Extended Release | Coupler LLC | ANDA |
| 72189-130 | Oxybutynin Chloride 5 mg/1 Tablet | direct rx | ANDA |
| 72189-131 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | direct rx | ANDA |
| 72189-132 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | DIRECT RX | ANDA |
| 51407-099 | Oxybutynin Chloride 5 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 23155-913 | Oxybutynin Chloride 5 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-810 | Oxybutynin Chloride 5 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 10702-201 | Oxybutynin Chloride 5 mg/1 Tablet | KVK-Tech, Inc. | ANDA |
| 62175-272 | Oxybutynin Chloride 15 mg/1 Tablet, Extended Release | Lannett Company, Inc. | ANDA |
| 62175-271 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | Lannett Company, Inc. | ANDA |
| 62175-270 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | Lannett Company, Inc. | ANDA |
| 54838-510 | Oxybutynin Chloride 5 mg/5mL Syrup | Lannett Company, Inc. | ANDA |
| 69315-182 | Oxybutynin Chloride 5 mg/1 Tablet | Leading Pharma, LLC | ANDA |
| 0904-7027 | Oxybutynin Chloride 5 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-6570 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | Major Pharmaceuticals | ANDA |
| 0615-8492 | Oxybutynin Chloride 5 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 82868-047 | Oxybutynin Chloride 5 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-665 | Oxybutynin Chloride 5 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 66267-642 | Oxybutynin Chloride 5 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 43063-790 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-851 | Oxybutynin Chloride 5 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-490 | Oxybutynin Chloride 5 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-417 | Oxybutynin Chloride 5 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-414 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-049 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-931 | Oxybutynin Chloride 5 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-8141 | Oxybutynin Chloride 5 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 82804-095 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 71205-667 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | Proficient Rx LP | ANDA |
| 63187-749 | Oxybutynin Chloride 5 mg/1 Tablet | Proficient Rx LP | ANDA |
| 67296-2045 | Oxybutynin Chloride 5 mg/1 Tablet | Redpharm Drug | ANDA |
| 70518-2640 | Oxybutynin Chloride 5 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 64980-679 | Oxybutynin Chloride 5 mg/1 Tablet | RISING PHARMA HOLDINGS, INC. | ANDA |
| 64980-734 | Oxybutynin Chloride 2.5 mg/1 Tablet | RISING PHARMA HOLDINGS, INC. | ANDA |
| 64980-209 | Oxybutynin Chloride 5 mg/1 Tablet, Extended Release | Rising Pharma Holdings, Inc. | ANDA |
| 64980-210 | Oxybutynin Chloride 10 mg/1 Tablet, Extended Release | Rising Pharma Holdings, Inc. | ANDA |
| 64980-211 | Oxybutynin Chloride 15 mg/1 Tablet, Extended Release | Rising Pharma Holdings, Inc. | ANDA |
| 64980-431 | Oxybutynin Chloride 5 mg/1 Tablet | RISING PHARMA HOLDINGS, INC. | ANDA |
| 64980-531 | Oxybutynin Chloride 2.5 mg/1 Tablet | RISING PHARMA HOLDINGS, INC. | ANDA |
| 64380-162 | Oxybutynin Chloride 5 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-190 | Oxybutynin Chloride 2.5 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-781 | Oxybutynin Chloride 5 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 50111-456 | Oxybutynin Chloride 5 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 52817-260 | Oxybutynin Chloride 5 mg/1 Tablet | TruPharma LLC | ANDA |
| 52817-261 | Oxybutynin Chloride 2.5 mg/1 Tablet | TruPharma LLC | ANDA |
| 0832-0038 | Oxybutynin Chloride 5 mg/1 Tablet | Upsher-Smith Laboratories, LLC | ANDA |
| 83939-0022 | Oxybutynin Chloride 5 mg/1 Tablet | VERITYRX, LLC | ANDA |
Oxybutynin Chloride recalls
- D-0990-2019 Mar 20, 2019 · Class III · Terminated
Failed Dissolution Specifications - D-0996-2019 Mar 20, 2019 · Class III · Terminated
Failed Dissolution Specifications - D-0340-2019 Dec 26, 2018 · Class II · Terminated
Labeling: Wrong bar code
Frequently asked questions
What is Oxybutynin Chloride used for?
Oxybutynin chloride tablets are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).
What are the side effects of Oxybutynin Chloride?
The safety and efficacy of oxybutynin chloride was evaluated in a total of 199 patients in three clinical trials. These participants were treated with oxybutynin chloride 5 to 20 mg/day for up to 6 weeks. Table 3 shows the incidence of adverse events judged by investigators to be at least possibly related to treatment and reported by at least 5% of patients. The most common adverse events… See the full label for the complete list.
Who makes Oxybutynin Chloride?
Oxybutynin Chloride is listed by 39 labelers in the FDA NDC directory, including A-S Medication Solutions, Accord Healthcare, Inc., Advagen Pharma Limited, Ajanta Pharma USA Inc..
Has Oxybutynin Chloride been recalled?
The FDA enforcement database lists 3 recalls for Oxybutynin Chloride, most recently D-0990-2019 (class iii): Failed Dissolution Specifications