Oxybutynin Chloride 5 mg Tablet, Extended Release, 100-count — NDC 27241-155-04 (Billing 27241-0155-04)
This is a package of 100 tablets of Oxybutynin Chloride 5 mg Tablet, Extended Release from Ajanta Pharma USA Inc., marketed since Feb 2019 and currently FDA-listed; retail pharmacies pay about $0.0841 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 27241-155-04 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 27241 labeler · 155 product · 04 package
- Package marketed since
- Feb 28, 2019
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 100 EA per package
- Barcode (UPC)
- 0327241156045, 0327241155048, 0327241157042
- Medicaid fills, this package
- 32,288 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 041046
- GCN: 19388
- GPI-14 (Medi-Span): 54100045207520
- HICL (First Databank): 002048
- AHFS class code: 86:12.04.00
- RxCUI (RxNorm): 863619
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Cholinergic Muscarinic Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Oxybutynin calms down an overactive bladder by relaxing the bladder muscle and reducing those sudden, hard-to-ignore urges to go. Over time, most people find they have fewer urgent...
- What exactly is oxybutynin supposed to do for me?
- Yes, dry mouth is the most common side effect of oxybutynin — and it's more noticeable with the immediate-release tablets than the extended-release form. Sipping water throughout t...
- My mouth is incredibly dry since starting this — is that normal?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.084 | $8.41 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.3126 | $31.26 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.3976 | $39.76 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 27241-0155-04 You're viewing this Main listing | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE | $0.0841 / ea | $8.41 | 2019-02-28 | — | Active |
| 27241-0155-08 27241-155-08 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE | $0.0841 / ea | $42.07 | 2019-02-28 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0841 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 60% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 27241-0155-08?
What NDC number is used to bill for this package of Oxybutynin Chloride 5 mg Tablet, Extended Release?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Oxybutynin Chloride 5 mg 00904-6570-04 | Major | 1 tablet | $0.084 | AB | Availability likely | — |
| Oxybutynin Chloride 5 mgthis 27241-0155-04 | Ajanta | 100 tablets | $0.084 | AB | Availability likely | — |
| Oxybutynin Chloride Extended Release 5 mg 50268-0627-15 | AvPAK | 1 tablet | $0.084 | AB | Availability likely | — |
| oxybutynin chloride 5 mg 62135-0507-90 | Chartwell | 90 tablets | $0.084 | AB | Availability likely | — |
| Oxybutynin Chloride Extended Release 5 mg 64980-0209-01 | Rising | 100 tablets | $0.084 | AB | Availability likely | — |
| Oxybutynin Chloride Extended Release 5 mg 68084-0480-01 | American | 1 tablet | $0.084 | AB | Availability likely | — |
| oxybutynin 5 mg 68382-0255-01 | Zydus | 100 tablets | $0.084 | AB | Availability likely | — |
| Oxybutynin Chloride 5 mg 72888-0030-01 | Advagen | 100 tablets | $0.084 | AB | Availability likely | — |
| oxybutynin chloride 5 mg 16729-0317-01 | Accord | 100 tablets | $0.090 | AB | Availability likely | +7% |
| oxybutynin 5 mg 00615-8219-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Oxybutynin Chloride Extended Release 5 mg 42291-0633-01 | AvKARE | 100 tablets | — | AB | FDA listed | — |
| Oxybutynin Chloride Extended Release 5 mg 43353-0282-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| Oxybutynin Chloride Extended Release 5 mg 43353-0285-30 | Aphena | 30 tablets | — | AB | FDA listed | — |
| oxybutynin chloride 5 mg 50090-5822-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Oxybutynin Chloride Extended Release 5 mg 50090-6840-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Oxybutynin Chloride Extended Release 5 mg 62175-0270-32 | Lannett | 30 tablets | — | AB | FDA listed | — |
| oxybutynin chloride 5 mg 63629-9689-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Oxybutynin Chloride 5 mg 65162-0371-03 | Amneal | 30 tablets | — | AB | FDA listed | — |
| Oxybutynin Chloride 5 mg 67046-1599-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| oxybutynin 5 mg 70771-1086-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Oxybutynin Chloride Extended Release 5 mg 71335-2330-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Oxybutynin Chloride 5 mg 72189-0131-30 | direct | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Oxybutynin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Ajanta Pharma USA Inc. labeler code 27241
- Silodosin 4 mg Capsule NDC 27241-144-01
- Silodosin 8 mg Capsule NDC 27241-145-01
- Dapagliflozin 5 mg Tablet NDC 27241-151-01
- Dapagliflozin 10 mg Tablet NDC 27241-152-01
- Doxycycline hyclate 75 mg Tablet NDC 27241-153-02
- Doxycycline hyclate 150 mg Tablet NDC 27241-154-02
- Oxybutynin Chloride 10 mg Tablet, Extended Release NDC 27241-156-04
- Oxybutynin Chloride 15 mg Tablet, Extended Release NDC 27241-157-04
- Valganciclovir 450 mg Tablet NDC 27241-158-60
- Valganciclovir hydrochloride 50 mg/mL Powder, For Solution NDC 27241-159-19
- Captopril 12.5 mg Tablet NDC 27241-160-01
- Captopril 25 mg Tablet NDC 27241-161-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Oxybutynin chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets is 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 is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
( 1 ) 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). ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Oxybutynin chloride extended-release tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. Oxybutynin chloride extended-release tablets may be administered with or without food. Oxybutynin chloride extended-release tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed.
Oxybutynin chloride extended-release tablets may be administered with or without food. ( 2 ) Adults: Start with 5 mg or 10 mg, once daily at approximately the same time every day. Dose should not exceed 30 mg per day.
( 2.1 ) Pediatric patients (6 years of age or older): Start with 5 mg, once daily at approximately the same time every day. Dose should not exceed 20 mg per day. ( 2.2 )
2.1Adults The recommended starting dose of oxybutynin chloride extended-release tablets is 5 mg or 10 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals.
2.2Pediatric Patients Aged 6 Years of Age and Older The recommended starting dose of oxybutynin chloride extended-release tablets is 5 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 20 mg/day).
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Oxybutynin chloride extended-release tablets, USP are available as 5 mg, 10 mg and 15 mg tablets for oral use: 5 mg: Light yellow to yellow colored, round, enteric coated tablets with “0B1” imprinted on one side with black ink. 10 mg: Light pink to pink colored, round, enteric coated tablets with “0B2” imprinted on one side with black ink. 15 mg: Light grey to grey colored, round, enteric coated tablets with “0B3” imprinted on one side with black ink.
Extended release tablets 5 mg, 10 mg and 15 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. Oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. There have been reports of hypersensitivity reactions, including anaphylaxis and angioedema.
Urinary retention (4) Gastric Retention (4) Uncontrolled narrow angle glaucoma (4) Known hypersensitivity to oxybutynin chloride extended-release tablets, oxybutynin or any component of oxybutynin chloride extended-release tablets (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Angioedema: Angioedema has been reported with oxybutynin. If symptoms of angioedema occur, discontinue oxybutynin chloride extended-release tablets immediately and initiate appropriate therapy. ( 5.1 ) Central Nervous System (CNS) effects: CNS effects have been reported with oxybutynin.
If patient experiences anticholinergic CNS effects, consider dose adjustment or discontinuation of oxybutynin chloride extended-release tablets. ( 5.2 ) Use with caution due to aggravation of symptoms: Pre-existing dementia in patients treated with cholinesterase inhibitors ( 5.2 ), Parkinson’s disease ( 5.2 ), Myasthenia gravis ( 5.3 ), and Decreased gastrointestinal motility in patients with autonomic neuropathy. ( 5.4 ).
Urinary Retention: Use with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention ( 5.5 ) Gastrointestinal Adverse Reactions: Use with caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility due to risk of gastric retention. Use with caution in patients with gastroesophageal reflux or in patients concurrently taking drugs that can exacerbate esophagitis. ( 5.6 )
5.1Angioedema 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.
5.2Central Nervous System Effects Oxybutynin is associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions ( 6)]. 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.
Advise patients not to drive or operate heavy machinery until they know how oxybutynin chloride extended-release tablets affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. Oxybutynin chloride extended-release tablets should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.
Oxybutynin chloride extended-release tablets should be used with caution in patients with Parkinson’s disease due to the risk of aggravation of symptoms.
5.3Worsening of Symptoms of Myasthenia Gravis Oxybutynin chloride extended-release tablets should be used with caution in patients with myasthenia gravis due to the risk of aggravation of symptoms.
5.4Worsening of Symptoms of Decreased Gastrointestinal Motility in Patients with Autonomic Neuropathy Oxybutynin chloride extended-release tablets should be used with caution in patients with autonomic neuropathy due to the risk of aggravation of symptoms of decreased gastrointestinal motility.
5.5Urinary Retention Oxybutynin chloride extended-release tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see Contraindications ( 4 )].
5.6Gastrointestinal Adverse Reactions Oxybutynin chloride extended-release tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see Contraindications ( 4 )]. Oxybutynin chloride extended-release tablets, 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 extended-release tablets should be used with caution in patients who have gastroesop… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common (incidence greater than or equal to 5%) adverse reactions were dry mouth, constipation, diarrhea, headache, somnolence, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc. at 1-855-664-7744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety and efficacy of oxybutynin chloride extended-release tablets (5 mg/day to 30 mg/day) was evaluated in 774 adult subjects who participated in five double-blind, controlled clinical trials. In four of the five studies, oxybutynin chloride tablets (5 mg/day to 20 mg/day in 199 subjects) was an active comparator.
Adverse reactions reported by greater than or equal to 1% of subjects are shown in Table 1. Table 1: Adverse Drug Reactions Reported by greater than or equal to 1% of Oxybutynin Chloride Extended-Release Tablets - treated Adult Subjects in Five Double-blind, Controlled Clinical Trials of Oxybutynin Chloride Extended-Release Tablets . System/Organ Class Preferred Term Oxybutynin Chloride Extended-Release Tablets 5 to 30 mg/day n=774 % Oxybutynin Chloride Tablets 1 5 to 20 mg/day n=199 % Psychiatric Disorders Insomnia 3.0
5.5Nervous System Disorders Headache 7.5
8.0Somnolence 5.6
14.1Dizziness 5.0
16.6Dysgeusia 1.6
1.5Eye Disorders Vision blurred 4.3
9.6Dry eye 3.1
2.5Respiratory, Thoracic and Mediastinal Disorders Cough 1.9
3.0Oropharyngeal pain 1.9
1.5Dry throat 1.7
2.5Nasal dryness 1.7
4.5Gastrointestinal Disorders Dry mouth 34.9
72.4Constipation 8.7
15.1Diarrhea 7.9
6.5Dyspepsia 4.5
6.0Nausea 4.5
11.6Abdominal pain 1.6
2.0Vomiting 1.3
1.5Flatulence 1.2
2.5Gastro-esophageal reflux disease 1.0
0.5Skin and Subcutaneous Tissue Disorders Dry skin 1.8
2.5Pruritus 1.3
1.5Renal and Urinary Disorders Dysuria 1.9
2.0Urinary hesitation 1.9
8.5Urinary retention 1.2
3.0General Disorders and Administration Site Conditions Fatigue 2.6
3.0Investigations Residual urine volume 2 2.3 3.5 1 Immediate-release formulation 2 The bundled term residual urine volume consists of the preferred terms residual urine volume and residual urine volume increased. The discontinuation rate due to adverse reactions was 4.4% with oxybutynin chloride extended-release tablets compared to 0% with oxybutynin chloride tablets. The most frequent adverse reaction causing discontinuation of study medication was dry mouth (0.7%).
The following adverse reactions were reported by less than 1% of oxybutynin chloride extended-release tablets-treated patients and at a higher incidence than placebo in clinical trials: Metabolism and Nutrition Disorders: anorexia, fluid retention; Vascular disorders: hot flush; Respiratory, thoracic and mediastinal disorders: dysphonia; Gastrointestinal Disorders: dysphagia, frequent bowel movements; General disorders and administration site conditions: chest discomfort, thirst.
6.2Postmarketing Experience The following additional adverse reactions have been reported from worldwide postmarketing experience with oxybutynin chloride extended-release tablets. Because postmarketing reactions 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. Infections and Infestations: Urinary tract infection; Psychiatric Disorders: psychotic disorder, agitation, confusional state, hallucinations, memory impairment, abnormal behavior; Nervous System Disorders: convulsions; Eye Disorders: glaucoma; Respiratory, Thoracic and Mediastinal Disorders: nasal congestion; Cardiac Disorders: arrhythmia, tachycardia, palpitations; QT interval prolongation; Vascular Disorders: flushing, hypertensi… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 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 prokinetic agents, such as metoclopramide. Mean oxybutynin plasma concentrations were approximately 2 fold higher when oxybutynin chloride extended-release tablets 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. Co-administration with other anticholinergic drugs may increase the frequency and/or severity of anticholinergic-like effects.
( 7 ) Co-administration with strong cytochrome P450 (CYP) 3A4 inhibitors (e.g., ketoconazole) increases the systemic exposure of oxybutynin. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric Use: Oxybutynin chloride extended-release tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing or crushing, or in children under the age of 6 years. ( 8.4 ) Renal or Hepatic Impairment: There have been no studies conducted in patients with renal or hepatic impairment. ( 8.6 , 8.7 )
8.1Pregnancy Risk Summary There are no adequate data on oxybutynin chloride extended-release tablets use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
8.2Lactation Risk Summary There are no data on the presence of oxybutynin in human milk, the effects on the breastfed infant, or the effects of oxybutynin chloride extended-release tablets on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for oxybutynin chloride extended-release tablets and any potential adverse effects on the breastfed child from oxybutynin chloride extended-release tablets or from the underlying maternal condition.
8.4Pediatric Use The safety and efficacy of oxybutynin chloride extended-release tablets were studied in 60 children in a 24-week, open-label, non-randomized trial. Patients were aged 6-15 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 administration of oxybutynin chloride extended-release tablets 5 mg/day to 20 mg/day was associated with an increase from baseline in mean urine volume per catheterization from 108 mL to 136 mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 189 mL, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 34% to 51%.
Urodynamic results were consistent with clinical results. Administration of oxybutynin chloride extended-release tablets resulted in an increase from baseline in mean maximum cystometric capacity from 185 mL to 254 mL, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 44 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 60% to 28%. The pharmacokinetics of oxybutynin chloride extended-release tablets in these patients were consistent with those reported for adults [see Clinical Pharmacology ( 12.3 )].
Oxybutynin chloride extended-release tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing, or crushing, or in children under the age of 6.
8.5Geriatric Use The rate and severity of anticholinergic effects reported by patients less than 65 years old and those 65 years and older were similar. The pharmacokinetics of oxybutynin chloride extended-release tablets were similar in all patients studied (up to 78 years of age).
8.6Renal Impairment There were no studies conducted with oxybutynin chloride extended-release tablets in patients with renal impairment.
8.7Hepatic Impairment There were no studies conducted with oxybutynin chloride extended-release tablets in patients with hepatic impairment.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate data on oxybutynin chloride extended-release tablets use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of oxybutynin chloride extended-release tablets were studied in 60 children in a 24-week, open-label, non-randomized trial. Patients were aged 6-15 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 administration of oxybutynin chloride extended-release tablets 5 mg/day to 20 mg/day was associated with an increase from baseline in mean urine volume per catheterization from 108 mL to 136 mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 189 mL, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 34% to 51%.
Urodynamic results were consistent with clinical results. Administration of oxybutynin chloride extended-release tablets resulted in an increase from baseline in mean maximum cystometric capacity from 185 mL to 254 mL, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 44 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 60% to 28%. The pharmacokinetics of oxybutynin chloride extended-release tablets in these patients were consistent with those reported for adults [see Clinical Pharmacology ( 12.3 )].
Oxybutynin chloride extended-release tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing, or crushing, or in children under the age of 6.
🧓 Geriatric Use ▾
8.5Geriatric Use The rate and severity of anticholinergic effects reported by patients less than 65 years old and those 65 years and older were similar. The pharmacokinetics of oxybutynin chloride extended-release tablets were similar in all patients studied (up to 78 years of age).
🆘 Overdosage ▾
10 OVERDOSAGE The continuous release of oxybutynin from oxybutynin chloride extended-release tablets should be considered in the treatment of overdosage. Patients should be monitored for at least 24 hours. Treatment should be symptomatic and supportive.
A cathartic may be administered. Overdosage with oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Oxybutynin relaxes bladder smooth muscle. Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia (antinicotinic effects).
Antimuscarinic activity resides predominantly in the R-isomer. A metabolite, desethyloxybutynin, has pharmacological activity similar to that of oxybutynin in in vitro studies.
12.2Pharmacodynamics In patients with conditions characterized by involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void.
12.3Pharmacokinetics Absorption Following the first dose of oxybutynin chloride extended-release tablets, oxybutynin plasma concentrations rise for 4 to 6 hours; thereafter steady concentrations are maintained for up to 24 hours, minimizing fluctuations between peak and trough concentrations associated with oxybutynin. The relative bioavailabilities of R- and S-oxybutynin from oxybutynin chloride extended-release tablets are 156% and 187%, respectively, compared with oxybutynin. The mean pharmacokinetic parameters for R and S-oxybutynin are summarized in Table 2.
The plasma concentration-time profiles for R- and S-oxybutynin are similar in shape; Figure 1 shows the profile for R-oxybutynin. Table 2: Mean (SD) R- and S-Oxybutynin Pharmacokinetic Parameters Following a Single Dose of Oxybutynin Chloride Extended-Release Tablets 10 mg (n=43) Parameters (units) R-Oxybutynin S-Oxybutynin C max (ng/mL) 1.0 (0.6) 1.8 (1.0) T max (h) 12.7 (5.4) 11.8 (5.3) t 1/2 (h) 13.2 (6.2) 12.4 (6.1) AUC (0-48) (ng•h/mL) 18.4 (10.3) 34.2 (16.9) AUC inf (ng•h/mL) 21.3 (12.2) 39.5 (21.2) Figure 1:Mean R-oxybutynin plasma concentrations following a single dose of Oxybutynin Chloride Extended-Release Tablets 10 mg and oxybutynin 5 mg administered every 8 hours (n=23 for each treatment).
Steady state oxybutynin plasma concentrations are achieved by Day 3 of repeated oxybutynin chloride extended-release tablets dosing, with no observed drug accumulation or change in oxybutynin and desethyloxybutynin pharmacokinetic parameters. Oxybutynin chloride extended-release tablets steady state pharmacokinetics were studied in 19 children aged 5 to15 years with detrusor overactivity associated with a neurological condition (e.g., spina bifida). The children were on oxybutynin chloride extended-release tablets total daily dose ranging from 5 mg to 20 mg (0.10 mg/kg to 0.77 mg/kg).
Sparse sampling technique was used to obtain serum samples. When all available data are normalized to an equivalent of 5 mg per day of oxybutynin chloride extended-release tablets the mean pharmacokinetic parameters derived for R- and S-oxybutynin and R- and S-desethyloxybutynin are summarized in Table 3. The plasma-time concentration profiles for R- and S-oxybutynin are similar in shape; Figure 2 shows the profile for R-oxybutynin when all available data are normalized to an equivalent of 5 mg per day.
Table 3: Mean ± SD R- and S-Oxybutynin and R- and S-Desethyloxybutynin Pharmacokinetic Parameters in Children Aged 5 to 15 Following Administration of 5 to 20 mg Oxybutynin Chloride Extended-Release Tablets Once Daily (n=19), All Available Data Normalized to an Equivalent of Oxybutynin Chloride Extended-Release Tablets 5 mg Once Daily R-Oxybutynin S-Oxybutynin R- Desethyl oxybutynin S-Desethyl oxybutynin C max (ng/mL) 0.7 ± 0.4 1.3 ± 0.8 7.8 ± 3.7 4.2 ±
2.3T max (h) 5.0 5.0 5.0
5.0AUC (ng•h/mL) 12.8 ± 7.0 23.7 ± 14.4 125.1 ± 66.7 73.6 ±
47.7Figure 2: Mean steady state (± SD) R-oxybutynin plasma concentrations following administration of 5 to 20 mg Oxybutynin Chloride Extended-Release Tablets once daily in children aged 5 to 15. Plot represents all available data normalize… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Oxybutynin relaxes bladder smooth muscle. Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia (antinicotinic effects).
Antimuscarinic activity resides predominantly in the R-isomer. A metabolite, desethyloxybutynin, has pharmacological activity similar to that of oxybutynin in in vitro studies.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Oxybutynin chloride extended-release tablets, USP are available in three dosage strengths, 5 mg (light yellow to yellow), 10 mg (light pink to pink), and 15 mg (light grey to grey) and are imprinted on one side with "0B1", "0B2", or "0B3" with black ink. Oxybutynin chloride extended-release tablets, USP are supplied in bottles of 100 tablets and 500 tablets. 5 mg 100 count bottle with child resistant closures NDC 27241-155-04 500 count bottle NDC 27241-155-08 10 mg 100 count bottle with child resistant closures NDC 27241-156-04 500 count bottle NDC 27241-156-08 15 mg 100 count bottle with child resistant closures NDC 27241-157-04 500 count bottle NDC 27241-157-08 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].
Protect from moisture and humidity. Keep out of reach of children.
📋 Description ▾
11 DESCRIPTION Oxybutynin chloride, USP is an antispasmodic, muscarinic antagonist. Each oxybutynin chloride extended-release tablet, USP contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride, USP is administered as a racemate of R- and S-enantiomers.
Chemically, oxybutynin chloride, USP is 4(diethylamino-but-2-ynyl (RS) 2-cyclohexyl-2-hydroxy 2 phenyl acetate hydrochloride. The molecular formula of oxybutynin chloride, USP is C 22 H 31 NO 3 •HCl. Its structural formula is: Oxybutynin chloride, USP is a white crystalline powder with a molecular weight of 393.95.
It is freely soluble in water and in alcohol, very soluble in methanol and in chloroform, soluble in acetone, slightly soluble in ether, very slightly soluble in hexane. Oxybutynin chloride extended-release tablets, USP also contains the following inert ingredients: anhydrous dibasic calcium phosphate, povidone, hypromellose, colloidal silicon dioxide, magnesium stearate, polyethylene glycol, methacrylic acid copolymer type c, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, ferrosoferric oxide, ferric oxide red (in 10 mg only) and iron oxide yellow (in 5 mg and 15 mg only).
The imprinting material contains: shellac glaze, black iron oxide, propylene glycol and ammonium hydroxide. Meets USP Dissolution Test 9. System Components and Performance Oxybutynin chloride extended-release tablets, USP are formulated to deliver oxybutynin chloride at a controlled rate over approximately 24 hours.
The dosage form is comprised of a hydrophilic cellulose polymer matrix tablet surrounded by an enteric coating system. The enteric coat is insoluble in the low pH environment of the stomach. As the tablet passes through the stomach and enters the higher pH environment of the small intestine, the enteric coating dissolves and/or erodes to expose the polymer matrix tablet which swells and releases drug at a controlled rate via diffusion and/or erosion. oxybutynin-structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION 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 swelling of the tongue, edema of the laryngopharynx, or difficulty breathing. Patients should be informed that anticholinergic (antimuscarinic) agents such as oxybutynin chloride extended-release tablets, may produce clinically significant adverse reactions related to anticholinergic activity such as: Urinary retention and constipation Heat prostration due to decreased sweating.
Heat prostration can occur when anticholinergic medicines are administered in the presence of high environmental temperature. Patients should be informed that anticholinergic medicines such as oxybutynin chloride extended-release tablets may produce drowsiness (somnolence), dizziness or blurred vision. Patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until oxybutynin chloride extended-release tablets effects have been determined.
Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin chloride extended-release tablets. Patients should be informed that oxybutynin chloride extended-release tablets should be swallowed whole with the aid of liquids. Patients should not chew, divide, or crush tablets.
Oxybutynin chloride extended-release tablets should be taken at approximately the same time each day. For more information call 1-855-664-7744. Product of India Manufactured by: Ajanta Pharma Limited, India Marketed by: Ajanta Pharma USA Inc.
Bridgewater, NJ 08807. #All trademarks are the properties of their respective owners Revised: 11/2025
🍼 Nursing Mothers ▾
8.2Lactation Risk Summary There are no data on the presence of oxybutynin in human milk, the effects on the breastfed infant, or the effects of oxybutynin chloride extended-release tablets on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for oxybutynin chloride extended-release tablets and any potential adverse effects on the breastfed child from oxybutynin chloride extended-release tablets or from the underlying maternal condition.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Following the first dose of oxybutynin chloride extended-release tablets, oxybutynin plasma concentrations rise for 4 to 6 hours; thereafter steady concentrations are maintained for up to 24 hours, minimizing fluctuations between peak and trough concentrations associated with oxybutynin. The relative bioavailabilities of R- and S-oxybutynin from oxybutynin chloride extended-release tablets are 156% and 187%, respectively, compared with oxybutynin. The mean pharmacokinetic parameters for R and S-oxybutynin are summarized in Table 2.
The plasma concentration-time profiles for R- and S-oxybutynin are similar in shape; Figure 1 shows the profile for R-oxybutynin. Table 2: Mean (SD) R- and S-Oxybutynin Pharmacokinetic Parameters Following a Single Dose of Oxybutynin Chloride Extended-Release Tablets 10 mg (n=43) Parameters (units) R-Oxybutynin S-Oxybutynin C max (ng/mL) 1.0 (0.6) 1.8 (1.0) T max (h) 12.7 (5.4) 11.8 (5.3) t 1/2 (h) 13.2 (6.2) 12.4 (6.1) AUC (0-48) (ng•h/mL) 18.4 (10.3) 34.2 (16.9) AUC inf (ng•h/mL) 21.3 (12.2) 39.5 (21.2) Figure 1:Mean R-oxybutynin plasma concentrations following a single dose of Oxybutynin Chloride Extended-Release Tablets 10 mg and oxybutynin 5 mg administered every 8 hours (n=23 for each treatment).
Steady state oxybutynin plasma concentrations are achieved by Day 3 of repeated oxybutynin chloride extended-release tablets dosing, with no observed drug accumulation or change in oxybutynin and desethyloxybutynin pharmacokinetic parameters. Oxybutynin chloride extended-release tablets steady state pharmacokinetics were studied in 19 children aged 5 to15 years with detrusor overactivity associated with a neurological condition (e.g., spina bifida). The children were on oxybutynin chloride extended-release tablets total daily dose ranging from 5 mg to 20 mg (0.10 mg/kg to 0.77 mg/kg).
Sparse sampling technique was used to obtain serum samples. When all available data are normalized to an equivalent of 5 mg per day of oxybutynin chloride extended-release tablets the mean pharmacokinetic parameters derived for R- and S-oxybutynin and R- and S-desethyloxybutynin are summarized in Table 3. The plasma-time concentration profiles for R- and S-oxybutynin are similar in shape; Figure 2 shows the profile for R-oxybutynin when all available data are normalized to an equivalent of 5 mg per day.
Table 3: Mean ± SD R- and S-Oxybutynin and R- and S-Desethyloxybutynin Pharmacokinetic Parameters in Children Aged 5 to 15 Following Administration of 5 to 20 mg Oxybutynin Chloride Extended-Release Tablets Once Daily (n=19), All Available Data Normalized to an Equivalent of Oxybutynin Chloride Extended-Release Tablets 5 mg Once Daily R-Oxybutynin S-Oxybutynin R- Desethyl oxybutynin S-Desethyl oxybutynin C max (ng/mL) 0.7 ± 0.4 1.3 ± 0.8 7.8 ± 3.7 4.2 ±
2.3T max (h) 5.0 5.0 5.0
5.0AUC (ng•h/mL) 12.8 ± 7.0 23.7 ± 14.4 125.1 ± 66.7 73.6 ±
47.7Figure 2: Mean steady state (± SD) R-oxybutynin plasma concentrations following administration of 5 to 20 mg Oxybutynin Chloride Extended-Release Tablets once daily in children aged 5 to 15. Plot represents all available data normalized to an equivalent of Oxybutynin Chloride Extended-Release Tablets 5 mg once daily. Food Effects The rate and extent of absorption and metabolism of oxybutynin are similar under fed and fasted conditions.
Distribution Oxybutynin is widely distributed in body tissues following systemic absorption. The volume of distribution is 193 L after intravenous administration of 5 mg oxybutynin chloride. Both enantiomers of oxybutynin are highly bound (greater than 99%) to plasma proteins.
Both enantiomers of N-desethyloxybutynin are also highly bound (greater than 97%) to plasma proteins. The major binding protein is alpha-1 acid glycoprotein. Metabolism Oxybutynin is metabolized primarily by the cytochrome P450 enzyme systems, particularly CYP3A4 found mostly in the liver and gut wall.
Its metabolic products include phenylcycloh… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics In patients with conditions characterized by involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Oxybutynin chloride extended-release tablets were evaluated for the treatment of patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in three controlled efficacy studies. The majority of patients were Caucasian (89.0%) and female (91.9%) with a mean age of 59 years (range, 18 to 98 years). Entry criteria required that patients have urge or mixed incontinence (with a predominance of urge) as evidenced by greater than or equal to 6 urge incontinence episodes per week and greater than or equal to 10 micturitions per day.
Study 1 was a fixed-dose escalation design, whereas the other two studies used a dose-adjustment design in which each patient’s final dose was adjusted to a balance between improvement of incontinence symptoms and tolerability of side effects. All three studies included patients known to be responsive to oxybutynin or other anticholinergic medications, and these patients were maintained on a final dose for up to 2 weeks. The efficacy results for the three controlled trials are presented in the following Tables 4, 5, and 6 and Figures 3, 4, and 5.
Table 4: Number of Urge Urinary Incontinence Episodes Per Week (Study 1) Study 1 n Oxybutynin Chloride Extended-Release Tablets n Placebo Mean Baseline 34 15.9 16
20.9Mean (SD) Change from Baseline † 34 -15.8 (8.9) 16 -7.6 (8.6) 95% Confidence Interval for Difference (-13.6, -2.8) * (Oxybutynin Chloride Extended-Release Tablets - Placebo) * The difference between oxybutynin chloride extended-release tablets and placebo was statistically significant. † Covariate adjusted mean with missing observations set to baseline values Figure 3: Mean Change (±SD) in Urge Urinary Incontinence Episodes Per Week from Baseline (Study 1) * The difference between oxybutynin chloride extended-release tablets and placebo was statistically significant.
Table 5: Number of Urge Urinary Incontinence Episodes Per Week (Study 2) Study 2 n Oxybutynin Chloride Extended-Release Tablets n oxybutynin Mean Baseline 53 27.6 52
23.0Mean (SD) Change from Baseline † 53 -17.6 (11.9) 52 -19.4 (11.9) 95% Confidence Interval for Difference (-2.8, 6.5) (Oxybutynin Chloride Extended-Release Tablets - Oxybutynin) † Covariate adjusted mean with missing observations set to baseline values Figure 4: Mean Change (±SD) in Urge Urinary Incontinence Episodes Per Week from Baseline (Study 2) Table 6: Number of Urge Urinary Incontinence Episodes Per Week (Study 3) Study 3 n Oxybutynin Chloride Extended-Release Tablets n oxybutynin Mean Baseline 111 18.9 115
19.5Mean (SD) Change from Baseline † 111 -14.5 (8.7) 115 -13.8 (8.6) 95% Confidence Interval for Difference (-3.0, 1.6) ** (Oxybutynin Chloride Extended-Release Tablets - Oxybutynin) ** The difference between oxybutynin chloride extended-release tablets and oxybutynin fulfilled the criteria for comparable efficacy. † Covariate adjusted mean with missing observations set to baseline values Figure 5: Mean Change (±SD) in Urge Urinary Incontinence Episodes Per Week from Baseline (Study 3) ** The difference between oxybutynin chloride extended-release tablets and oxybutynin fulfilled the criteria for comparable efficacy. figure3 figure4 figure5
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis A 24-month study in rats at dosages of oxybutynin chloride of 20 mg/kg/day, 80 mg/kg/day, 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 a human equivalent dose taking into account normalization of body surface area. Mutagenesis Oxybutynin chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae , and Salmonella typhimurium test systems.
Impairment of Fertility No impairment of fertility was seen in rats at dosages up to 75 mg/kg/day (24 times the MRHD on a mg/m2 basis) when administered for 2 weeks prior to mating in females and for 9 weeks prior to mating in males.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis A 24-month study in rats at dosages of oxybutynin chloride of 20 mg/kg/day, 80 mg/kg/day, 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 a human equivalent dose taking into account normalization of body surface area. Mutagenesis Oxybutynin chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae , and Salmonella typhimurium test systems.
Impairment of Fertility No impairment of fertility was seen in rats at dosages up to 75 mg/kg/day (24 times the MRHD on a mg/m2 basis) when administered for 2 weeks prior to mating in females and for 9 weeks prior to mating in males.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 27241-155-04 100 Tablets Oxybutynin Chloride Extended-Release Tablets, USP 5 mg Rx Only ajanta NDC 27241-156-04 100 Tablets Oxybutynin Chloride Extended-Release Tablets, USP 10 mg Rx Only ajanta NDC 27241-157-04 100 Tablets Oxybutynin Chloride Extended-Release Tablets, USP 15 mg Rx Only ajanta 5mg 10mg 15mg