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. 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 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. The recommended starting dose of Oxybutynin chloride extended-release tablets is 5 or 10 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to ac...
Oxybutynin chloride extended-release tablets 5 mg are round, biconvex, white coated tablets imprinted in black ink with "270" on one side and "KU" on the other side. They are supplied as follows: NDC 50268-627-15 (10 Tablets per card, 5 cards per carton) Oxybutynin chloride extended-release tablets 10 mg are round, biconvex, white coated tablets imprinted in black ink with "271" on one side and "KU" on the other s...
www.fda.gov/medwatchOxybutynin 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 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.
The recommended starting dose of Oxybutynin chloride extended-release tablets is 5 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.
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).
Oxybutynin chloride extended-release tablets are available as 5, 10 and 15 mg tablets for oral use:
5 mg: White, round, biconvex tablet with "270" printed on one side and "KU" printed on the other side with black ink.
10 mg: White, round, biconvex tablet with "271" printed on one side and "KU" printed on the other side with black ink.
15 mg: White, round, biconvex tablet with "272" printed on one side and "KU" printed on the other side with black ink.
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 angiodema.
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.
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 affect 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.
Oxybutynin chloride extended-release tablets should be used with caution in patients with myasthenia gravis due to the risk of symptom aggravation.
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.
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)].
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 gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.
As with any other nondeformable material, caution should be used when administering Oxybutynin chloride extended-release tablets to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs in nondeformable controlled-release formulations.
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 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 IR (5 to 20 mg/day in 199 subjects) was an active comparator. Adverse reactions reported by ≥ 1% of subjects are shown in Table 1.
| System/Organ Class
Preferred Term | Oxybutynin chloride extended-release tablets
5 to 30 mg/day n = 774 % | Oxybutynin chloride IR
*
5 to 20 mg/day n = 199 % |
|---|---|---|
| Psychiatric Disorders | ||
| Insomnia | 3.0 | 5.5 |
| Nervous System Disorders | ||
| Headache | 7.5 | 8.0 |
| Somnolence | 5.6 | 14.1 |
| Dizziness | 5.0 | 16.6 |
| Dysgeusia | 1.6 | 1.5 |
| Eye Disorders | ||
| Vision blurred | 4.3 | 9.6 |
| Dry eye | 3.1 | 2.5 |
| Respiratory, Thoracic and Mediastinal Disorders | ||
| Cough | 1.9 | 3.0 |
| Oropharyngeal pain | 1.9 | 1.5 |
| Dry throat | 1.7 | 2.5 |
| Nasal dryness | 1.7 | 4.5 |
| Gastrointestinal Disorders | ||
| Dry mouth | 34.9 | 72.4 |
| Constipation | 8.7 | 15.1 |
| Diarrhea | 7.9 | 6.5 |
| Dyspepsia | 4.5 | 6.0 |
| Nausea | 4.5 | 11.6 |
| Abdominal pain | 1.6 | 2.0 |
| Vomiting | 1.3 | 1.5 |
| Flatulence | 1.2 | 2.5 |
| Gastro-esophageal reflux disease | 1.0 | 0.5 |
| Skin and Subcutaneous Tissue Disorders | ||
| Dry skin | 1.8 | 2.5 |
| Pruritus | 1.3 | 1.5 |
| Renal and Urinary Disorders | ||
| Dysuria | 1.9 | 2.0 |
| Urinary hesitation | 1.9 | 8.5 |
| Urinary retention | 1.2 | 3.0 |
| General Disorders and Administration Site Conditions | ||
| Fatigue | 2.6 | 3.0 |
| Investigations | ||
| Residual urine volume † | 2.3 | 3.5 |
* IR = immediate release
† 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 IR. The most frequent adverse reaction causing discontinuation of study medication was dry mouth (0.7% ).
The following adverse reactions were reported by <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.
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; 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, hypertension; Skin and Subcutaneous Tissue Disorders: rash; Renal and Urinary Disorders: impotence; General Disorders and Administration Site Conditions: hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; anaphylactic reactions requiring hospitalization for emergency treatment; Injury, poisoning and procedural complications: fall.
Additional adverse events reported with some other oxybutynin chloride formulations include: cycloplegia, mydriasis, and suppression of lactation.
To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 chloride plasma concentrations were approximately 2 fold higher when Oxybutynin chloride extended-release tablets were 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 Category B. There are no adequate and well-controlled studies using Oxybutynin chloride extended-release tablets in pregnant women. Oxybutynin chloride extended-release tablets should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during Oxybutynin chloride extended-release tablets treatment are encouraged to contact their physician.
Risk Summary
Based on animal data, oxybutynin is predicted to have a low probability of increasing the risk of adverse developmental effects above background risk.
Animal Data
Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility or harm to the animal fetus.
It is not known whether oxybutynin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Oxybutynin chloride extended-release tablets are administered to a nursing woman.
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 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 2O to 33 cm H 2O, and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H 2O) 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.
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).
There were no studies conducted with Oxybutynin chloride extended-release tablets in patients with renal impairment.
There were no studies conducted with Oxybutynin chloride extended-release tablets in patients with hepatic impairment.
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. 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, 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.
Oxybutynin chloride extended-release tablets are an antispasmodic, muscarinic antagonist. Each Oxybutynin chloride extended-release tablets 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 is administered as a racemate of R- and S-enantiomers.
Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C 22H 31NO 3•HCl.
Its structural formula is:
Oxybutynin chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis.
Oxybutynin chloride extended-release tablets also contain the following inert ingredients: lactose, mannitol, dextrose, tartaric acid, colloidal silicon dioxide, magnesium stearate, cellulose acetate, polyethylene glycol, titanium dioxide, triacetin, black iron oxide, propylene glycol, hypromellose.
System Components and Performance
Oxybutynin chloride extended-release tablets uses osmotic pressure to deliver oxybutynin chloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active core surrounded by a semipermeable membrane. The unitary tablet core is composed of the drug and excipients (including the osmotically active components). There is a precision-laser drilled orifice in the semipermeable membrane on the side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to go into suspension and the osmotic components to expand. This expansion pushes the drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of Oxybutynin chloride extended-release tablets depends on the existence of an osmotic gradient between the contents of the core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell.
USP Drug Release Test 3.
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.
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.
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.
| 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 5–15 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 to 20 mg (0.10 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.
| R-Oxybutynin | S-Oxybutynin | R- Desethyloxybutynin | S- Desethyloxybutynin | |
|---|---|---|---|---|
| C max (ng/mL) | 0.7 ± 0.4 | 1.3 ± 0.8 | 7.8 ± 3.7 | 4.2 ± 2.3 |
| T max (h) | 5.0 | 5.0 | 5.0 | 5.0 |
| AUC (ng∙h/mL) | 12.8 ± 7.0 | 23.7 ± 14.4 | 125.1 ± 66.7 | 73.6 ± 47.7 |
Figure 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 5–15. 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 (>99%) to plasma proteins. Both enantiomers of N-desethyloxybutynin are also highly bound (>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 phenylcyclohexylglycolic acid, which is pharmacologically inactive, and desethyloxybutynin, which is pharmacologically active. Following Oxybutynin chloride extended-release tablets administration, plasma concentrations of R- and S-desethyloxybutynin are 73% and 92%, respectively, of concentrations observed with oxybutynin.
Excretion
Oxybutynin is extensively metabolized by the liver, with less than 0.1% of the administered dose excreted unchanged in the urine. Also, less than 0.1% of the administered dose is excreted as the metabolite desethyloxybutynin.
Dose Proportionality
Pharmacokinetic parameters of oxybutynin and desethyloxybutynin (C max and AUC) following administration of 5–20 mg of Oxybutynin chloride extended-release tablets are dose proportional.
Use in Specific Populations
Pediatric
The pharmacokinetics of Oxybutynin chloride extended-release tablets were evaluated in 19 children aged 5–15 years with detrusor overactivity associated with a neurological condition (e.g., spina bifida). The pharmacokinetics of Oxybutynin chloride extended-release tablets in these pediatric patients were consistent with those reported for adults (see Tables 2 and 3, and Figures 1 and 2 above).
Gender
There are no significant differences in the pharmacokinetics of oxybutynin in healthy male and female volunteers following administration of Oxybutynin chloride extended-release tablets.
Race
Available data suggest that there are no significant differences in the pharmacokinetics of oxybutynin based on race in healthy volunteers following administration of Oxybutynin chloride extended-release tablets.
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 a human equivalent dose taking into account normalization of body surface area.
Oxybutynin chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae, and Salmonella typhimurium test systems.
Reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility.
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 ≥ 6 urge incontinence episodes per week and ≥ 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 and figures.
| Study 1 | n | Oxybutynin chloride extended-release tablets | n | Placebo |
|---|---|---|---|---|
| Mean Baseline | 34 | 15.9 | 16 | 20.9 |
| Mean (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) | ||||
* Covariate adjusted mean with missing observations set to baseline values
† The difference between Oxybutynin chloride extended-release tabletsand placebo was statistically significant.
| Study 2 | n | Oxybutynin chloride extended-release tablets | n | oxybutynin |
|---|---|---|---|---|
| Mean Baseline | 53 | 27.6 | 52 | 23.0 |
| Mean (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
| Study 3 | n | Oxybutynin chloride extended-release tablets | n | oxybutynin |
|---|---|---|---|---|
| Mean Baseline | 111 | 18.9 | 115 | 19.5 |
| Mean (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) | ||||
* Covariate adjusted mean with missing observations set to baseline values
† The difference between Oxybutynin chloride extended-release tabletsand oxybutynin fulfilled the criteria for comparable efficacy.
Oxybutynin chloride extended-release tablets 5 mg are round, biconvex, white coated tablets imprinted in black ink with "270" on one side and "KU" on the other side.
They are supplied as follows:
NDC 50268-627-15 (10 Tablets per card, 5 cards per carton)
Oxybutynin chloride extended-release tablets 10 mg are round, biconvex, white coated tablets imprinted in black ink with "271" on one side and "KU" on the other side.
They are supplied as follows:
NDC 50268-628-15 (10 Tablets per card, 5 cards per carton)
Oxybutynin chloride extended-release tablets 15 mg are round, biconvex, white coated tablets imprinted in black ink with "272" on one side and "KU" on the other side.
They are supplied as follows:
NDC 50268-629-13 (10 Tablets per card, 3 cards per carton)
Dispensed in Unit Dose package. For Institutional Use Only.
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.
Keep out of reach of children.
For more information call 1-855-361-3993.
Manufactured for:
AvKARE Pulaski, TN 38478
Mfg. Rev. 05/23
AV Rev. 03/25(M)
AvPAK
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 863619 | oxyBUTYnin chloride 10 MG 24HR Extended Release Oral Tablet | PSN | 8 |
| 863628 | oxyBUTYnin chloride 15 MG 24HR Extended Release Oral Tablet | PSN | 8 |
| 863636 | oxyBUTYnin chloride 5 MG 24HR Extended Release Oral Tablet | PSN | 8 |
| 863619 | 24 HR oxybutynin chloride 10 MG Extended Release Oral Tablet | SCD | 8 |
| 863628 | 24 HR oxybutynin chloride 15 MG Extended Release Oral Tablet | SCD | 8 |
| 863636 | 24 HR oxybutynin chloride 5 MG Extended Release Oral Tablet | SCD | 8 |
| 863619 | oxybutynin chloride 10 MG 24 HR Extended Release Oral Tablet | SY | 8 |
| 863628 | oxybutynin chloride 15 MG 24 HR Extended Release Oral Tablet | SY | 8 |
| 863636 | oxybutynin chloride 5 MG 24 HR Extended Release Oral Tablet | SY | 8 |
| Class | Version | Type | Effective |
|---|---|---|---|
| OXYBUTYNIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| 3544f362-07fc-93b1-457b-1fba00be087a | Product name | 8 | 20230316 |
| 4daffbf2-44c8-ca46-d284-5db69e1e6ef4 | Product name | 8 | 20210525 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 982338c6-c45c-b6b4-1452-14b01fbdf98d | Product name | 2 | 20180801 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 054197ba-7ed3-0ddb-321e-dbb51c0fe9b6 | Product name | 2 | 20171212 |
| 3544f362-07fc-93b1-457b-1fba00be087a | Product name | 2 | 20171212 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
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| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50268-627-11 | Oxybutynin ChlorideExtended Release | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | 8 | |
| 50268-627-15 | Oxybutynin ChlorideExtended Release | 50 in 1 BOX | TABLET, EXTENDED RELEASE | 50 | 8 | |
| 50268-628-11 | Oxybutynin ChlorideExtended Release | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | 8 | |
| 50268-628-15 | Oxybutynin ChlorideExtended Release | 50 in 1 BOX | TABLET, EXTENDED RELEASE | 50 | 8 | |
| 50268-629-11 | Oxybutynin ChlorideExtended Release | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | 8 | |
| 50268-629-13 | Oxybutynin ChlorideExtended Release | 30 in 1 BOX | TABLET, EXTENDED RELEASE | 30 | 8 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50268-627 | OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250418_242b4766-bc2b-0073-d72d-1bf879bbee24.zip |
| 50268-628 | OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250418_242b4766-bc2b-0073-d72d-1bf879bbee24.zip |
| 50268-629 | OXYBUTYNIN CHLORIDE EXTENDED RELEASE (OXYBUTYNIN CHLORIDE) TABLET, EXTENDED RELEASE [AVPAK] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250418_242b4766-bc2b-0073-d72d-1bf879bbee24.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OXYBUTYNIN CHLORIDE | ACTIVE INGREDIENT | L9F3D9RENQ | 4 | |
| OXYBUTYNIN | ACTIVE MOIETY | K9P6MC7092 | 4 | |
| ANHYDROUS DEXTROSE | INACTIVE INGREDIENT | 5SL0G7R0OK | 4 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | 4 | |
| CELLULOSE ACETATE | INACTIVE INGREDIENT | 3J2P07GVB6 | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 4 | |
| HYPROMELLOSE 2208 (100 MPA.S) | INACTIVE INGREDIENT | B1QE5P712K | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 4 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 4 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 4 | |
| TARTARIC ACID | INACTIVE INGREDIENT | W4888I119H | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 4 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50268-627 | 50268-627-11, 50268-627-15 |
| 62175-270 | |
| 50268-628 | 50268-628-11, 50268-628-15 |
| 62175-271 | |
| 50268-629 | 50268-629-11, 50268-629-13 |
| 62175-272 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, EXTENDED RELEASE / ORAL | 2575 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, EXTENDED RELEASE / ORAL | 1086 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| HYPROMELLOSE 2208 (100 MPA.S) | HYPROMELLOSE 2208 (100 MPA.S) | B1QE5P712K | TABLET, EXTENDED RELEASE / ORAL | 1700 mg | ||
| HYPROMELLOSE 2208 (100 MPA.S) | HYPROMELLOSE 2208 (100 MPA.S) | B1QE5P712K | TABLET, EXTENDED RELEASE / ORAL | 1700 mg | ||
| CELLULOSE ACETATE | CELLULOSE ACETATE | 3J2P07GVB6 | TABLET, EXTENDED RELEASE / ORAL | 187 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| HYPROMELLOSE 2208 (100 MPA.S) | HYPROMELLOSE 2208 (100 MPA.S) | B1QE5P712K | TABLET, EXTENDED RELEASE / ORAL | 1700 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| CELLULOSE ACETATE | CELLULOSE ACETATE | 3J2P07GVB6 | TABLET, EXTENDED RELEASE / ORAL | 187 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| ANHYDROUS DEXTROSE | ANHYDROUS DEXTROSE | 5SL0G7R0OK | TABLET, EXTENDED RELEASE / ORAL | 30 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, EXTENDED RELEASE / ORAL | 1086 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, EXTENDED RELEASE / ORAL | 2575 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, EXTENDED RELEASE / ORAL | 1086 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, EXTENDED RELEASE / ORAL | 60 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, EXTENDED RELEASE / ORAL | 60 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, EXTENDED RELEASE / ORAL | 26 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| CELLULOSE ACETATE | CELLULOSE ACETATE | 3J2P07GVB6 | TABLET, EXTENDED RELEASE / ORAL | 187 mg | ||
| HYPROMELLOSE 2208 (100 MPA.S) | HYPROMELLOSE 2208 (100 MPA.S) | B1QE5P712K | TABLET, EXTENDED RELEASE / ORAL | 1700 mg | ||
| HYPROMELLOSE 2208 (100 MPA.S) | HYPROMELLOSE 2208 (100 MPA.S) | B1QE5P712K | TABLET, EXTENDED RELEASE / ORAL | 1700 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, EXTENDED RELEASE / ORAL | 2575 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, EXTENDED RELEASE / ORAL | 2575 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| ANHYDROUS DEXTROSE | ANHYDROUS DEXTROSE | 5SL0G7R0OK | TABLET, EXTENDED RELEASE / ORAL | 30 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, EXTENDED RELEASE / ORAL | 1086 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, EXTENDED RELEASE / ORAL | 26 mg | ||
| HYPROMELLOSE 2208 (100 MPA.S) | HYPROMELLOSE 2208 (100 MPA.S) | B1QE5P712K | TABLET, EXTENDED RELEASE / ORAL | 1700 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, EXTENDED RELEASE / ORAL | 1086 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, EXTENDED RELEASE / ORAL | 60 mg | ||
| CELLULOSE ACETATE | CELLULOSE ACETATE | 3J2P07GVB6 | TABLET, EXTENDED RELEASE / ORAL | 187 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | TABLET, EXTENDED RELEASE / ORAL | 96 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, EXTENDED RELEASE / ORAL | 2575 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, EXTENDED RELEASE / ORAL | 60 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | TABLET, EXTENDED RELEASE / ORAL | 96 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, EXTENDED RELEASE / ORAL | 60 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | TABLET, EXTENDED RELEASE / ORAL | 96 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078503-001 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | |
| A078503-002 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | |
| A078503-003 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 |
| Application-product | TE code |
|---|---|
| A078503-001 | AB |
| A078503-002 | AB |
| A078503-003 | AB |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078503-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-02-04 | 301d65b070ca… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078503-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078503-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078503-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078503-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078503-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078503-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078503-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078503-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078503-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078503-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078503-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078503-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078503-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078503-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078503-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078503-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078503-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078503-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078503-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078503-001 | AB | 1 | 301d65b070ca… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | AvPAK | 242b4766-bc2b-0073-d72d-1bf879bbee24 | 2025-04-17 | Warnings, Adverse reactions | 50268-628-11 50268-627-11 50268-627-15 50268-629-13 50268-628-15 50268-629-11 50268-628 50268-627 50268-629 50268062811 50268062913 50268062715 50268062815 50268062911 50268062711 32feb2f4-2ee5-6219-e063-6394a90a9ef9 242b4766-bc2b-0073-d72d-1bf879bbee24 |
| Oxybutynin Chloride Extended Release | OXYBUTYNIN CHLORIDE | Lannett Company, Inc. | c5950dba-d92b-46a0-993f-af9f9ddb52bf | 2023-05-30 | Warnings, Adverse reactions | 62175-272 62175-271 62175-270 |
Adverse event summaries are temporarily unavailable. Other product information remains available.