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, 10 mg – Each light pink, film-coated, round convex tablet is debossed with "G 342" on one side and plain on the other side. Bottles of 2400 NDC 0179-0187-88 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity. Dispense in a tightly-closed, light-resistant container (USP).
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: | Light purple, film-coated, round convex tablets, debossed with "G 341" on one side and plain on the other side. |
| 10 mg: | Light pink, film-coated, round convex tablets, debossed with "G 342" on one side and plain on the other side. |
| 15 mg: | Off-white, film-coated, round convex tablets, debossed with "G 343" on one side and plain on the other side. |
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.
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 myasthenia gravis due to the risk of symptom aggravation.
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) were evaluated in 774 adult subjects who participated in five double-blind, controlled clinical trials. In four of the five studies, oxybutynin chloride immediate release tablets (5 to 20 mg/day in 199 subjects) were 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
* Tablets 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 immediate release tablets. 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.
Psychiatric Disorders: psychotic disorder, agitation, hallucinations, memory impairment; Nervous System Disorders: convulsions; Eye Disorders: glaucoma; Cardiac Disorders: arrhythmia, tachycardia, QT interval prolongation; Vascular Disorders: flushing; 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.
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.
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 to 15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride. Study results demonstrated that 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 tablet 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 inactive ingredients: hydrogenated vegetable oil, hypromellose, lactose monohydrate, methyacrylic acid copolymer, microcrystalline cellulose, talc and triethyl citrate. The 5 mg tablets contain FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. The 10 mg tablets contain FD&C Red No. 40 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake.
System Components and Performance
Oxybutynin chloride extended-release tablets employ an enteric-coated hydrophilic hydrogel matrix to deliver oxybutynin chloride at a controlled rate over approximately 24 hours. The system comprises a core, which consists of the drug, rate-controlling hydrogel and other excipients. The core is surrounded by a pH-dependent membrane. In an acidic environment such as the stomach, minimal drug release will occur due to the resistance of the pH-dependent outer membrane. Upon reaching an environment of pH 5.5 and above, the outer membrane dissolves exposing the inner core tablet, which partially hydrates to form a gel layer. Drug release is via slow diffusion out of the gel layer and subsequent gel erosion.
This product meets USP Drug Release Test #4.
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 tabletst 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 to 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-Desethyl-
oxybutynin | S-Desethyl-
oxybutynin | |
|---|---|---|---|---|
| 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 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 (>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 to 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 to 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 tablets and 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 tablets and oxybutynin fulfilled the criteria for comparable efficacy.
Oxybutynin chloride extended-release tablets, 10 mg – Each light pink, film-coated, round convex tablet is debossed with "G 342" on one side and plain on the other side.
| Bottles of 2400 | NDC 0179-0187-88 |
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.
Dispense in a tightly-closed, light-resistant container (USP).
For more information call 1-888-838-2872.
Manufactured By:
IMPAX Laboratories, Inc.
Hayward, CA 94544 USA
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rx only
675-04
Rev. 10/2013
Repackaged By:
KAISER FOUNDATION HOSPITALS
Livermore, CA 94551
PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label
NDC 0179- 0187-88
OXYBUTYNIN CHLORIDE
Extended-Release Tablets
10 mg
Each film-coated, extended-release tablet
contains 10 mg of oxybutynin chloride USP.
Rx only
2400 TABLETS
KAISER FOUNDATION HOSPITALS
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-5207-01 | EA - Each | 0093-5207 | f9a57950-70f3-47c2-8004-dce033c16e14 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OXYBUTYNIN CHLORIDE | ACTIVE INGREDIENT | L9F3D9RENQ | 1 | |
| OXYBUTYNIN | ACTIVE MOIETY | K9P6MC7092 | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 1 | |
| METHACRYLIC ACID | INACTIVE INGREDIENT | 1CS02G8656 | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0179-0187 | 0179-0187-88 |
| 0093-5207 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| METHACRYLIC ACID | 1CS02G8656 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TRIETHYL CITRATE | 8Z96QXD6UM | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| OXYBUTYNIN CHLORIDE | L9F3D9RENQ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION / SUBCUTANEOUS | 98 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, SUGAR COATED / ORAL | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, COATED / ORAL | 300 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, DELAYED RELEASE / ORAL | 2087 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SYRUP / ORAL | 4 mg/5ml | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, FILM COATED / ORAL | 1 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / ORAL | 75.3 mg/15ml | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 150 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 1 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING / ORAL | 80 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYRUP / ORAL | 250 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER / ORAL | 50 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | LOTION / TOPICAL | 0.1 %w/w | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, DELAYED RELEASE / ORAL | 2313 mg | ||
| TALC | TALC | 7SEV7J4R1U | ELIXIR / ORAL | 4.5 mg/5ml | ||
| TALC | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FOR SUSPENSION / ORAL | 2794 mg | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION / ORAL | 234 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, EXTENDED RELEASE / ORAL | 5119 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INHALANT / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED / ORAL | 0.03 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 100 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE / ORAL | 8946 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SYRUP / ORAL | 3 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 47.5 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SPONGE / TOPICAL | 0.01 %w/w | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, COATED / ORAL | 7 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, EXTENDED RELEASE / ORAL | 4.59 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE / ORAL | 3990 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, COATED / ORAL | 3.17 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | SUSPENSION, EXTENDED RELEASE / ORAL | 5 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / SUBLINGUAL | 1 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, ORALLY DISINTEGRATING / ORAL | 17 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER, FOR SUSPENSION / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE / ORAL | 45 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| TALC | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | FILM / SUBLINGUAL | 0.03 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / SUBLINGUAL | 505 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 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 |
|---|---|---|---|---|---|---|---|
| A076745-001 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | ||
| A076745-002 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | ||
| A076745-003 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A076745-001 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A076745-002 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A076745-003 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076745-001 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076745-002 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076745-003 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076745-001 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076745-002 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076745-003 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076745-001 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076745-002 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076745-003 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076745-001 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076745-002 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076745-003 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076745-001 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076745-002 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076745-003 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076745-001 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076745-002 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076745-003 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076745-001 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076745-002 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076745-003 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076745-001 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076745-002 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076745-003 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076745-001 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076745-002 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076745-003 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076745-001 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076745-002 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076745-003 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076745-001 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076745-002 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076745-003 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076745-001 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076745-002 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076745-003 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2007-05-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076745-001 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2006-11-09 | 79d66fd596c7… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A076745-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076745-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076745-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A076745-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076745-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076745-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076745-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076745-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076745-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076745-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076745-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076745-003 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| 7bea8f7b-5283-26f9-e053-2991aa0afaec | c6e40946-b4cf-4b01-a3c5-4f2297843cc2 | 2018-11-30 | Warnings, Adverse reactions | 7bea8f7b-5283-26f9-e053-2991aa0afaec c6e40946-b4cf-4b01-a3c5-4f2297843cc2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.