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Oxybutynin Chloride 5 mg Tablet, 42-count — NDC 71335-0519-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Oxybutynin Chloride 5 mg Tablet, 42-count — NDC 71335-0519-6 (Billing 71335-0519-06)

by Bryant Ranch Prepack · 42 TABLET in 1 BOTTLE

This is a package of 42 tablets of Oxybutynin Chloride 5 mg Tablet from Bryant Ranch Prepack, marketed since Sep 1990 and currently FDA-listed.

NDC 71335-0519-06
🏷️ FDA NDC (as labeled) 71335-0519-6 billing pads the package segment with a zero
This package
Contains42-count Pack sizes8 compare ↓
Also priced by: Part D plans $0.1412/unit — full pricing hub ↓
Product page 71335-0519-01 Also comes in: 15 tablets 71335-0519-7 20 tablets 71335-0519-3 30 tablets 71335-0519-1 60 tablets 71335-0519-4 90 tablets 71335-0519-5 100 tablets 71335-0519-2 180 tablets 71335-0519-8
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 71335-0519-6 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71335 labeler · 0519 product · 6 package
Package marketed since
Jul 22, 2008
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
42 EA per package
Barcode (UPC-A, from the NDC)
3 7133505196 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71335-0519-6
Product NDC 71335-0519
11-digit billing NDC 71335051906
NCPDP billing unit EA — each (per item)
RxCUI 863664
UNII L9F3D9RENQ
Application # ANDA071655
SPL Set ID 246d2f79-8ab5-4023-9068-1451b695ac16
Established class (EPC) Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1990-09-30
Route ORAL
Dosage form TABLET
Substance OXYBUTYNIN CHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 54100045200330
GPI class Oxybutynin Chloride
Quick answers
  • GPI-14 (Medi-Span): 54100045200330
  • RxCUI (RxNorm): 863664
Why two NDCs? The FDA registers this code as 71335-0519-6 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71335-0519-06. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Cholinergic Muscarinic Antagonist class.

Pharmacologic class Cholinergic Muscarinic Antagonist
Drug family (ATC) Drugs for urinary frequency and incontinence
How it works Cholinergic Muscarinic Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Oxybutynin is used to treat overactive bladder (a bladder condition that causes sudden urges to urinate that may be hard to control) and to control bladder muscles weakened in certain nerve conditions. Oxybutynin is in a class of medications called anticholinergics/antimuscarinics. It works by relaxing the bladder muscles.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Oxybutynin calms down an overactive bladder by relaxing the bladder muscle and reducing those sudden, hard-to-ignore urges to go. Over time, most people find they have fewer urgent...
  • What exactly is oxybutynin supposed to do for me?
  • Yes, dry mouth is the most common side effect of oxybutynin — and it's more noticeable with the immediate-release tablets than the extended-release form. Sipping water throughout t...
  • My mouth is incredibly dry since starting this — is that normal?
📖 Read our full Oxybutynin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1412 $5.93 / 42 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71335-0519-01 71335-0519-1 Main listing 30 TABLET in 1 BOTTLE 2008-07-22 — Active
71335-0519-02 71335-0519-2 100 TABLET in 1 BOTTLE 2008-07-22 — Active
71335-0519-03 71335-0519-3 20 TABLET in 1 BOTTLE 2008-07-22 — Active
71335-0519-04 71335-0519-4 60 TABLET in 1 BOTTLE 2008-07-22 — Active
71335-0519-05 71335-0519-5 90 TABLET in 1 BOTTLE 2008-07-22 — Active
71335-0519-06 You're viewing this 42 TABLET in 1 BOTTLE 2008-07-22 — Active
71335-0519-07 71335-0519-7 15 TABLET in 1 BOTTLE 2008-07-22 — Active
71335-0519-08 71335-0519-8 180 TABLET in 1 BOTTLE 2008-07-22 — Active

You're viewing one of 8 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 42-count package — 42 tablet in 1 bottle.
How does this package differ from NDC 71335-0519-07?
Both are Oxybutynin Chloride 5 mg Tablet — the drug itself is identical. This page's package is the 42-count one, while NDC 71335-0519-07 is the 15 tablets package.
What NDC number is used to bill for this package of Oxybutynin Chloride 5 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oxybutynin Chloride 5 mg 00832-0038-00 Upsher-Smith 100 tablets $0.048 AB Availability likely —
Oxybutynin Chloride 5 mg 00904-7027-61 Major 100 tablets $0.048 AB Availability likely —
Oxybutynin Chloride 5 mg 10702-0201-01 KVK-Tech, 100 tablets $0.048 AB Availability likely —
Oxybutynin Chloride 5 mg 23155-0810-01 Heritage 100 tablets $0.048 AB Availability likely —
Oxybutynin Chloride 5 mg 50111-0456-01 Teva 100 tablets $0.048 AB Availability likely —
Oxybutynin Chloride 5 mg 52817-0260-10 TruPharma 100 tablets $0.048 AB Availability likely —
Oxybutynin Chloride 5 mg 60687-0899-01 American 100 tablets $0.048 AB Availability likely —
Oxybutynin Chloride 5 mg 64380-0162-01 Strides 100 tablets $0.048 AB Availability likely —
Oxybutynin Chloride 5 mg 64980-0431-01 RISING 100 tablets $0.048 AB Availability likely —
Oxybutynin Chloride 5 mg 69315-0182-01 Leading 100 tablets $0.048 AB Availability likely —
Oxybutynin Chloride 5 mg 70954-0005-10 ANI 100 tablets $0.048 AB Availability likely —
Oxybutynin Chloride 5 mg 00615-8492-05 NCS 15 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 23155-0913-01 Heritage 100 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 42291-0456-50 AvKARE 500 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 43063-0851-01 PD-Rx 100 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 43063-0931-30 PD-Rx 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 43353-0978-92 Aphena 270 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 50090-4622-00 A-S 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 50090-6199-00 A-S 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 50090-6638-00 A-S 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 50090-6966-00 A-S 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 50090-6967-00 A-S 90 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 50090-7766-00 A-S 90 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 51407-0099-01 Golden 100 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 51655-0665-25 Northwind 60 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 55154-2632-00 Cardinal 10 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 63187-0749-30 Proficient 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 64380-0781-03 Strides 60 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 64980-0679-01 RISING 100 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 66267-0642-30 NuCare 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 67296-2045-03 Redpharm 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 68788-8141-09 Preferred 90 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 70518-2640-00 REMEDYREPACK 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mgthis 71335-0519-06 Bryant 42 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 71335-1014-01 Bryant 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 71335-1494-01 Bryant 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 71610-0277-53 Aphena 60 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 71610-0394-53 Aphena 60 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 71610-0860-30 Aphena 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 72189-0130-30 direct 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 72789-0417-30 PD-Rx 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 72789-0490-60 PD-Rx 60 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 82868-0047-30 Northwind 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 83939-0022-01 VERITYRX, 1 tablet — AB FDA listed —
Oxybutynin Chloride 5 mg 67046-1381-03 Coupler 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 50090-8078-00 A-S 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1990
On the market since
Sep 1990
📍
2026
Currently FDA-listed
36 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Blue
ShapeRound
ImprintPLIVA;456
Size8 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII 776XM7047L
    Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA071655 (ANDA)
Labeler code71335
First marketedSep 1990
Product typeHuman Prescription Drug
Portfolio4,436 products on file

More NDCs from Bryant Ranch Prepack labeler code 71335

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 words ▾

INDICATIONS AND USAGE Oxybutynin Chloride Tablets USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).

⏱️ Dosage and Administration 82 words ▾

DOSAGE AND ADMINISTRATION Adults The usual dose is one 5 mg tablet two to three times a day. The maximum recommended dose is one 5 mg tablet four times a day. A lower starting dose of 2.5 mg two or three times a day is recommended for the frail elderly. Pediatric Patients Over 5 Years of Age The usual dose is one 5 mg tablet two times a day. The maximum recommended dose is one 5 mg tablet three times a day.

⛔ Contraindications 53 words ▾

CONTRAINDICATIONS Oxybutynin chloride is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. Oxybutynin chloride is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

⚠️ Warnings 61 words ▾

WARNINGS Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The safety and efficacy of oxybutynin chloride was evaluated in a total of 199 patients in three clinical trials. These participants were treated with oxybutynin chloride 5 to 20 mg/day for up to 6 weeks. Table 3 shows the incidence of adverse events judged by investigators to be at least possibly related to treatment and reported by at least 5% of patients.

Table 3: Incidence (%) of Adverse Events Reported by ≥ 5% of Patients Using Oxybutynin Chloride (5 to 20 mg/day) Body System Adverse Event Oxybutynin Chloride (5 to 20 mg/day) (n = 199) Infections and Infestations Urinary tract infection 6.5% Psychiatric Disorders Insomnia 5.5% Nervousness 6.5% Nervous System Disorders Dizziness 16.6% Somnolence 14% Headache 7.5% Eye Disorders Blurred vision 9.6% Gastrointestinal Disorders Dry mouth 71.4% Constipation 15.1% Nausea 11.6% Dyspepsia 6% Renal and Urinary Disorders Urinary Hesitation 8.5% Urinary Retention 6% The most common adverse events reported by patients receiving oxybutynin chloride 5 to 20 mg/day were the expected side effects of anticholinergic agents.

The incidence of dry mouth was dose-related. In addition, the following adverse events were reported by 1 to < 5% of patients using oxybutynin chloride (5 to 20 mg/day) in all studies . Infections and Infestations : nasopharyngitis, upper respiratory tract infection, bronchitis, cystitis, fungal infection; Metabolism and Nutrition Disorders : fluid retention; Psychiatric Disorders : confusional state; Nervous System Disorders : dysgeusia, sinus headache; Eye Disorders : keratoconjunctivitis sicca, eye irritation; Cardiac Disorders : palpitations, sinus arrhythmia; Vascular Disorders : flushing; Respiratory, Thoracic and Mediastinal Disorders : nasal dryness, cough, pharyngolaryngeal pain, dry throat, sinus congestion, hoarseness, asthma, nasal congestion; Gastrointestinal Disorders : diarrhea, abdominal pain, loose stools, flatulence, vomiting, abdominal pain upper, dysphagia, aptyalism, eructation, tongue coated; Skin and Subcutaneous Tissue Disorders : dry skin, pruritis; Musculoskeletal and Connective Tissue Disorders : back pain, arthralgia, pain in extremity, flank pain; Renal and Urinary Disorders : dysuria, pollakiuria; General Disorders and Administration Site Conditions : fatigue, edema peripheral, asthenia, pain, thirst, edema; Investigations : blood pressure increased, blood glucose increased, blood pressure decreased; Injury, Poisoning, and Procedural Complications : fall.

Postmarketing Surveillance Because postmarketing adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following additional adverse events have been reported from worldwide postmarketing experience with oxybutynin chloride: Psychiatric Disorders : psychotic disorder, agitation, hallucination, memory impairment; Nervous System Disorders : convulsions; Eye Disorders : cycloplegia, mydriasis, glaucoma; Cardiac Disorders : tachycardia, QT interval prolongation; Gastrointestinal Disorders : decreased gastrointestinal motility; Skin and Subcutaneous Tissue Disorders : rash, decreased sweating; Renal and Urinary Disorders : impotence; Reproductive System and Breast Disorders : suppression of lactation; General Disorders and Administration Site Conditions: hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; rare anaphylactic reactions requiring hospitalization for emergency treatment.

🔄 Drug Interactions 143 words ▾

Drug Interactions The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a narrow therapeutic index.

Mean oxybutynin chloride plasma concentrations were approximately 3 to 4 fold higher when oxybutynin chloride was administered with ketoconazole, a potent CYP3A4 inhibitor. Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C max and AUC). The clinical relevance of such potential interactions is not known.

Caution should be used when such drugs are coadministered.

🤰 Pregnancy 75 words ▾

Pregnancy Teratogenic Effects Category B Reproduction studies using oxybutynin chloride in the hamster, rabbit, rat, and mouse have shown no definite evidence of impaired fertility or harm to the animal fetus. The safety of oxybutynin chloride administered to women who are or who may become pregnant has not been established. Therefore, oxybutynin chloride should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards.

🧒 Pediatric Use ~1 min read ▾

Pediatric Use The safety and efficacy of oxybutynin chloride administration have been demonstrated for pediatric patients 5 years of age and older (see DOSAGE AND ADMINISTRATION ). The safety and efficacy of oxybutynin chloride tablets were studied in 30 children in a 24 week, open-label trial. Patients were aged 5 to 15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride.

Study results demonstrated that the administration of oxybutynin chloride was associated with improvement in clinical and urodynamic parameters. At total daily doses ranging from 5 mg to 15 mg, treatment with oxybutynin chloride tablets was associated with an increase from baseline in mean urine volume per catheterization from 122 mL to 145 mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 168 mL, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 43% to 61%.

Urodynamic results in these patients were consistent with the clinical results. Treatment with oxybutynin chloride tablets was associated with an increase from baseline in maximum cystometric capacity from 230 mL to 279 mL, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 36 cm H 2 O to 33 cm H 2 O, and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H 2 O) from 39% to 20%. As there is insufficient clinical data for pediatric populations under age 5, oxybutynin chloride is not recommended for this age group.

🆘 Overdosage 112 words ▾

OVERDOSAGE Treatment should be symptomatic and supportive. Activated charcoal as well as a cathartic may be administered. Overdosage with oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation (e.g., restlessness, tremor, irritability, convulsions, delirium, hallucinations), flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention.

Other symptoms may include hypotension or hypertension, respiratory failure, paralysis, and coma. Ingestion of 100 mg oxybutynin chloride in association with alcohol has been reported in a 13-year-old boy who experienced memory loss, and a 34-year-old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients fully recovered with symptomatic treatment.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. Oxybutynin chloride exhibits only one fifth of the anticholinergic activity of atropine on the rabbit detrusor muscle, but four to ten times the antispasmodic activity. No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia (antinicotinic effects).

Oxybutynin chloride relaxes bladder smooth muscle. In patients with conditions characterized by involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin chloride increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void. Oxybutynin chloride thus decreases urgency and the frequency of both incontinent episodes and voluntary urination.

Antimuscarinic activity resides predominately in the R-isomer. A metabolite, desethyloxybutynin, has pharmacological activity similar to that of oxybutynin in in vitro studies. Pharmacokinetics Absorption Following oral administration of oxybutynin chloride tablets, oxybutynin is rapidly absorbed achieving C max within an hour, following which plasma concentration decreases with an effective half-life of approximately 2 to 3 hours.

The absolute bioavailability of oxybutynin is reported to be about 6% (range 1.6 to 10.9%) for the tablets. Wide interindividual variation in pharmacokinetic parameters is evident following oral administration of oxybutynin. The mean pharmacokinetic parameters for R- and S-oxybutynin are summarized in Table 1 .

The plasma concentration-time profiles for R- and S-oxybutynin are similar in shape; Figure 1 shows the profile for R-oxybutynin. Table 1: Mean (SD) R- and S-Oxybutynin Pharmacokinetic Parameters Following Three Doses of Oxybutynin Chloride 5 mg Administered Every 8 Hours (n = 23) Parameters (Units) R-Oxybutynin S-Oxybutynin C max (ng/mL) 3.6 (2.2) 7.8 (4.1) T max (h) 0.89 (0.34) 0.65 (0.32) AUC t (ng⋅h/mL) 22.6 (11.3) 35 (17.3) AUC inf (ng⋅h/mL) 24.3 (12.3) 37.3 (18.7) Figure 1. Mean R-Oxybutynin Plasma Concentrations Following Three Doses of Oxybutynin Chloride 5 mg Administered Every 8 Hours for 1 Day in 23 Healthy Adult Volunteers Oxybutynin chloride steady-state pharmacokinetics were also studied in 11 pediatric patients with detrusor overactivity associated with a neurological condition (e.g., spina bifida).

These pediatric patients were on oxybutynin chloride tablets with total daily dose ranging from 7.5 mg to 15 mg (0.22 to 0.53 mg/kg). Overall, most patients (86.9%) were taking a total daily oxybutynin chloride dose between 10 mg and 15 mg. Sparse sampling technique was used to obtain serum samples.

When all available data are normalized to an equivalent of 5 mg twice daily oxybutynin chloride, the mean pharmacokinetic parameters derived for R- and S-oxybutynin and R- and S-desethyloxybutynin are summarized in Table 2 . 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 twice daily. Table 2: Mean ± SD R- and S-Oxybutynin and R- and S-Desethyloxybutynin Pharmacokinetic Parameters in Children Aged 5 to 15 Following Administration of 7.5 mg to 15 mg Total Daily Dose of Oxybutynin Chloride Tablets (N = 11) All Available Data Normalized to an Equivalent of Oxybutynin Chloride Tablets 5 mg BID or TID at Steady-State R-Oxybutynin S-Oxybutynin R-Desethyloxybutynin S-Desethyloxybutynin C max Reflects C max for pooled data (ng/mL) 6.1 ± 3.2 10.1 ± 7.5 55.4 ± 17.9 28.2 ± 10 T max (hr) 1 1 2 2 AUC AUC 0-end of dosing interval (ng.hr/mL) 19.8 ± 7.4 28.4 ± 12.7 238.8 ± 77.6 119.5 ±

50.7Figure 2. Mean Steady-State (± SD) R-Oxybutynin Plasma Concentrations Following Administration of Total Daily Oxybutynin Chloride Tablet Dose of 7.5 mg to 15 mg (0.22 mg/kg to 0.53 mg/kg… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 139 words ▾

HOW SUPPLIED Oxybutynin Chloride Tablets USP are available as follows: 5 mg – Very pale blue, round, biconvex, scored tablets. Debossed with PLIVA 456 on one side and scored on the other side. NDC: 71335-0519-1 30 TABLET in a BOTTLE NDC: 71335-0519-2 100 TABLET in a BOTTLE NDC: 71335-0519-3 20 TABLET in a BOTTLE NDC: 71335-0519-4 60 TABLET in a BOTTLE NDC: 71335-0519-5 90 TABLET in a BOTTLE NDC: 71335-0519-6 42 TABLET in a BOTTLE NDC: 71335-0519-7 15 TABLET in a BOTTLE NDC: 71335-0519-8 180 TABLET in a BOTTLE Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc.

Burbank, CA 91504

📋 Description 107 words ▾

DESCRIPTION Oxybutynin Chloride Tablets USP are very pale blue, round, biconvex, scored, debossed tablets containing 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride, USP is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The structural formula appears below: C 22 H 31 NO 3 •HCl M.W.

393.9 Oxybutynin chloride, USP is a white crystalline solid. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin Chloride Tablets USP also contain calcium stearate, microcrystalline cellulose, anhydrous lactose, sodium starch glycolate and FD&C Blue #1 Aluminum Lake.

Oxybutynin Chloride Tablets USP are for oral administration. Meets USP Dissolution Test 2. Therapeutic Category: Antispasmodic, anticholinergic.

Oxybutynin Structural Formula

💬 Information for Patients 116 words ▾

Information for Patients Patients should be informed that oxybutynin may produce angioedema that could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing. Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin chloride are administered in the presence of high environmental temperature.

Because anticholinergic agents such as oxybutynin may produce drowsiness (somnolence), or blurred vision, patients should be advised to exercise caution. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Central Nervous System Effects Oxybutynin is associated with anticholinergic central nervous system (CNS) effects (see ADVERSE REACTIONS ). A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose.

If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. Oxybutynin chloride should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms. General Oxybutynin chloride should be used with caution in the frail elderly, in patients with hepatic or renal impairment, and in patients with myasthenia gravis.

Oxybutynin chloride may aggravate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hiatal hernia, tachycardia, hypertension, myasthenia gravis, and prostatic hypertrophy. Urinary Retention Oxybutynin chloride should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention (see CONTRAINDICATIONS ). Gastrointestinal Disorders Oxybutynin chloride should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention (see CONTRAINDICATIONS ).

Administration of oxybutynin chloride to patients with ulcerative colitis may suppress intestinal motility to the point of producing a paralytic ileus and precipitate or aggravate toxic megacolon, a serious complication of the disease. Oxybutynin chloride, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, and intestinal atony. Oxybutynin chloride should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.

Information for Patients Patients should be informed that oxybutynin may produce angioedema that could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing. Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin chloride are administered in the presence of high environmental temperature.

Because anticholinergic agents such as oxybutynin may produce drowsiness (somnolence), or blurred vision, patients should be advised to exercise caution. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin. Drug Interactions The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects.

Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a narrow therapeutic index. Mean oxybutynin chloride plasma concentrations were approximately 3 to 4 fold higher when oxybutynin chloride was administered with ketoconazole, a potent CYP3A4 inhibitor.

Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C max and AUC). The clinical relevance of such potential int… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 35 words ▾

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when oxybutynin chloride is administered to a nursing woman.

🔬 Clinical Studies 35 words ▾

CLINICAL STUDIES Oxybutynin chloride was well tolerated in patients administered the drug in controlled studies of 30 days’ duration and in uncontrolled studies in which some of the patients received the drug for 2 years.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 84 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility A 24 month study in rats at dosages of oxybutynin chloride of 20, 80, and 160 mg/kg/day showed no evidence of carcinogenicity. These doses are approximately 6, 25, and 50 times the maximum human exposure, based on surface area. Oxybutynin chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae and Salmonella typhimurium test systems.

Reproduction studies using oxybutynin chloride in the hamster, rabbit, rat, and mouse have shown no definite evidence of impaired fertility.

📚 References 124 words ▾

REFERENCES Yong C et al. Effect of Food on the Pharmacokinetics of Oxybutynin in normal subjects. Pharm Res .

1991; 8 (Suppl.): S-320. Hughes KM et al. Measurement of oxybutynin and its N-desethyl metabolite in plasma, and its application to pharmacokinetic studies in young, elderly and frail elderly volunteers.

Xenobiotica . 1992; 22 (7): 859-869. Ouslander J et al.

Pharmacokinetics and Clinical Effects of Oxybutynin in Geriatric Patients. J. Urol .

1988; 140: 47-50. Yarker Y et al. Oxybutynin: A review of its Pharmacodynamic and Pharmacokinetic Properties, and its Therapeutic Use in Detrusor Instability.

Drugs & Aging . 1995; 6(3): 243-262. Manufactured In Bulgaria By: Balkanpharma Dupnitsa AD Dupnitsa 2600, Bulgaria Manufactured For: Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454 Rev. D 9/2015

📄 Package Label / Principal Display Panel 7 words ▾

Oxybutynin Chloride 5 mg Tablets Label Image

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Oxybutynin Chloride — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Oxybutynin Chloride. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$7.83M
Claims incl. refills
449.3K
Beneficiaries
297K
Spend / beneficiary
$26.37
Spend / claim
$17.43
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 7 other package presentations of this same product, including 15 tablets (71335-0519-07), 20 tablets (71335-0519-03), 30 tablets (71335-0519-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71335-0514-01 · Bryant 71335-0534-01 · Bryant →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.