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Oxybutynin Chloride Extended Release 5 mg Tablet, Extended Release, 500-count — NDC 64980-0209-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Oxybutynin Chloride Extended Release 5 mg Tablet, Extended Release, 500-count — NDC 64980-209-05 (Billing 64980-0209-05)

by Rising Pharma Holdings, Inc. · 500 TABLET, EXTENDED RELEASE in 1 BOTTLE

This is a package of 500 tablets of Oxybutynin Chloride Extended Release 5 mg Tablet, Extended Release from Rising Pharma Holdings, Inc., marketed since Sep 2016 and currently FDA-listed; retail pharmacies pay about $0.0841 per tablet (NADAC).

NDC 64980-0209-05
🏷️ FDA NDC (as labeled) 64980-209-05 billing pads the product segment with a zero
This package
Contains500-count Cost per ea$0.0841 NADAC Per package$42.05 / 500 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.3484/unit · Part D plans $0.3976/unit — full pricing hub ↓
Product page 64980-0209-01 Also comes in: 30 tablets 64980-209-03 100 tablets 64980-209-01
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64980-209-05
Product NDC 64980-209
11-digit billing NDC 64980020905
NCPDP billing unit EA — each (per item)
RxCUI 863619, 863628, 863636
UNII L9F3D9RENQ
UPC 0364980211017, 0364980210010, 0364980209014
Application # ANDA206121
SPL Set ID ab431781-3183-4638-b656-f40a61f07940
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 2016-09-27
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
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 54100045207520
GPI class Oxybutynin Chloride ER
GCN Seq No 041046
GCN 19388
HICL code 002048
Ingredient (HICL) Oxybutynin Chloride
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1A
Therapeutic class — specific (HIC3) Urinary Tract Antispasmodic/Antiincontinence Agent
AHFS code 86:12.04.00
AHFS class Antimuscarinics
FDB label name OXYBUTYNIN CL ER 5 MG TABLET
FDB brand name Oxybutynin Chloride Er
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 041046
  • GCN: 19388
  • GPI-14 (Medi-Span): 54100045207520
  • HICL (First Databank): 002048
  • AHFS class code: 86:12.04.00
  • RxCUI (RxNorm): 863619
Why two NDCs? The FDA registers this code as 64980-209-05 — a 5-3-2 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 product segment → 64980-0209-05. 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

Label name OXYBUTYNIN CL ER 5 MG TABLET Ingredient Oxybutynin Chloride
📗 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 eaPer package
Retail pharmacies payNADAC · weekly $0.084 $42.05 / 500 tablets
Medicaid paysCMS SDUD · 12 mo $0.3484 $174.20 / 500 tablets
Medicare drug plans payPart D · Q2 2026 $0.3976 $198.80 / 500 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $0.111 $0.082
▼ Down 18% over the last 13 months.
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 Per unit Per pack Marketing startMarketing endStatus
64980-0209-01 64980-209-01 Main listing 100 TABLET, EXTENDED RELEASE in 1 BOTTLE $0.0841 / ea $8.41 2016-09-27 — Active
64980-0209-03 64980-209-03 30 TABLET, EXTENDED RELEASE in 1 BOTTLE — — 2022-03-29 — Active
64980-0209-05 You're viewing this 500 TABLET, EXTENDED RELEASE in 1 BOTTLE $0.0841 / ea $42.07 2022-03-29 — Active

You're viewing the largest of 3 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0841 NADAC).

This pack accounts for about 27% of this product's recent Medicaid fills; most go to the 100 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet, extended release in 1 bottle.
How does this package differ from NDC 64980-0209-03?
Both are Oxybutynin Chloride Extended Release 5 mg Tablet, Extended Release — the drug itself is identical. This page's package is the 500-count one, while NDC 64980-0209-03 is the 30 tablets package.
What NDC number is used to bill for this package of Oxybutynin Chloride Extended Release 5 mg Tablet, Extended Release?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oxybutynin Chloride 5 mg 00904-6570-04 Major 1 tablet $0.084 AB Availability likely —
Oxybutynin Chloride 5 mg 27241-0155-04 Ajanta 100 tablets $0.084 AB Availability likely —
Oxybutynin Chloride Extended Release 5 mg 50268-0627-15 AvPAK 1 tablet $0.084 AB Availability likely —
oxybutynin chloride 5 mg 62135-0507-90 Chartwell 90 tablets $0.084 AB Availability likely —
Oxybutynin Chloride Extended Release 5 mgthis 64980-0209-05 Rising 500 tablets $0.084 AB Availability likely —
Oxybutynin Chloride Extended Release 5 mg 68084-0480-01 American 1 tablet $0.084 AB Availability likely —
oxybutynin 5 mg 68382-0255-01 Zydus 100 tablets $0.084 AB Availability likely —
Oxybutynin Chloride 5 mg 72888-0030-01 Advagen 100 tablets $0.084 AB Availability likely —
oxybutynin chloride 5 mg 16729-0317-01 Accord 100 tablets $0.090 AB Availability likely +7%
oxybutynin 5 mg 00615-8219-39 NCS 30 tablets — AB FDA listed —
Oxybutynin Chloride Extended Release 5 mg 42291-0633-01 AvKARE 100 tablets — AB FDA listed —
Oxybutynin Chloride Extended Release 5 mg 43353-0282-30 Aphena 30 tablets — AB FDA listed —
Oxybutynin Chloride Extended Release 5 mg 43353-0285-30 Aphena 30 tablets — AB FDA listed —
oxybutynin chloride 5 mg 50090-5822-00 A-S 90 tablets — AB FDA listed —
Oxybutynin Chloride Extended Release 5 mg 50090-6840-00 A-S 90 tablets — AB FDA listed —
Oxybutynin Chloride Extended Release 5 mg 62175-0270-32 Lannett 30 tablets — AB FDA listed —
oxybutynin chloride 5 mg 63629-9689-01 Bryant 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 65162-0371-03 Amneal 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 67046-1599-03 Coupler 30 tablets — AB FDA listed —
oxybutynin 5 mg 70771-1086-01 Zydus 100 tablets — AB FDA listed —
Oxybutynin Chloride Extended Release 5 mg 71335-2330-01 Bryant 30 tablets — AB FDA listed —
Oxybutynin Chloride 5 mg 72189-0131-30 direct 30 tablets — AB FDA listed —
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

🏛️
2016
On the market since
Sep 2016
📍
2026
Currently FDA-listed
10 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 Yellow / Pink / Gray
ShapeRound
ImprintP15
Size7 mm
ScoringNot scored
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 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 3J2P07GVB6
    Cellulose acetate is a plant-derived polymer made by chemically modifying cellulose fibers. In medications, it serves as a film-coating material for tablets and capsules to protect the drug, control release, and improve appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 0VUT3PMY82
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 11628IH70O
    Polyethylene oxide is a synthetic polymer derived from ethylene. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust texture, and a disintegrant to help the tablet or capsule break apart for absorption.
  • UNII G3MS6M810Y
    Polyethylene glycol 7000000 is a synthetic polymer used as a binder and filler in medications. It helps hold tablet ingredients together and can improve how the medicine dissolves in your body.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

17 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

LabelerRising Pharma Holdings, Inc.
Application holderUNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD
FDA applicationANDA206121 (ANDA)
Labeler code64980
First marketedSep 2016
Product typeHuman Prescription Drug
Portfolio525 products on file
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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 120 words ▾

1 INDICATIONS AND USAGE 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 are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

( 1 ) Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Oxybutynin chloride extended-release tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. Oxybutynin chloride extended-release tablets may be administered with or without food. Oxybutynin chloride extended-release tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed.

Oxybutynin chloride extended-release tablets may be administered with or without food. ( 2 ) Adults: Start with 5 mg or 10 mg, once daily at approximately the same time every day. Dose should not exceed 30 mg per day.

( 2.1 ) Pediatric patients (6 years of age or older): Start with 5 mg, once daily at approximately the same time every day. Dose should not exceed 20 mg per day. ( 2.2 )

2.1Adults The recommended starting dose of oxybutynin chloride extended-release tablets are 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.

2.2Pediatric Patients Aged 6 Years of Age and Older The recommended starting dose of oxybutynin chloride extended-release tablets is 5 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 20 mg/day).

💊 Dosage Forms and Strengths 84 words ▾

3 DOSAGE FORMS AND STRENGTHS Oxybutynin chloride extended-release tablets USP are available as 5, 10 and 15 mg tablets for oral use: 5 mg: Pale yellow colored, round, biconvex tablets with orifice and "P 5" imprinted with black ink. 10 mg: Pink colored, round, biconvex tablets with orifice and "P 10" imprinted with black ink. 15 mg: Grey colored, round, biconvex tablets with orifice and "P 15" imprinted with black ink.

Extended release tablets 5 mg, 10 mg and 15 mg ( 3 )

⛔ Contraindications 95 words ▾

4 CONTRAINDICATIONS Oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. Oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. There have been reports of hypersensitivity reactions, including anaphylaxis and angioedema.

Urinary retention ( 4 ) Gastric Retention ( 4 ) Uncontrolled narrow angle glaucoma ( 4 ) Known hypersensitivity to oxybutynin chloride extended-release tablets, oxybutynin or any component of oxybutynin chloride extended-release tablets. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Angioedema: Angioedema has been reported with oxybutynin. If symptoms of angioedema occur, discontinue oxybutynin chloride extended-release tablets immediately and initiate appropriate therapy. ( 5.1 ) Central Nervous System (CNS) effects: CNS effects have been reported with oxybutynin.

If patient experiences anticholinergic CNS effects, consider dose adjustment or discontinuation of oxybutynin chloride extended-release tablets. ( 5.2 ) Use with caution due to aggravation of symptoms: Pre-existing dementia in patients treated with cholinesterase inhibitors ( 5.2 ), Parkinson’s disease ( 5.2 ), Myasthenia gravis ( 5.3 ), and Decreased gastrointestinal motility in patients with autonomic neuropathy ( 5.4 ). Urinary Retention: Use with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.

( 5.5 ) Gastrointestinal Adverse Reactions: Use with caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility due to risk of gastric retention. Use with caution in patients with gastroesophageal reflux or in patients concurrently taking drugs that can exacerbate esophagitis. ( 5.6 )

5.1Angioedema Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

5.2Central Nervous System Effects Oxybutynin is associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6) ] . A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose.

Advise patients not to drive or operate heavy machinery until they know how oxybutynin chloride extended-release tablets affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. Oxybutynin chloride extended-release tablets should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.

Oxybutynin chloride extended-release tablets should be used with caution in patients with Parkinson’s disease due to the risk of aggravation of symptoms.

5.3Worsening of Symptoms of Myasthenia Gravis Oxybutynin chloride extended-release tablets should be used with caution in patients with myasthenia gravis due to the risk of aggravation of symptoms.

5.4Worsening of Symptoms of Decreased Gastrointestinal Motility in Patients with Autonomic Neuropathy Oxybutynin chloride extended-release tablets should be used with caution in patients with autonomic neuropathy due to the risk of aggravation of symptoms of decreased gastrointestinal motility.

5.5Urinary Retention Oxybutynin chloride extended-release tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see Contraindications (4) ] .

5.6Gastrointestinal Adverse Reactions Oxybutynin chloride extended-release tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see Contraindications (4) ] . Oxybutynin chloride extended-release tablets, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis and intestinal atony. Oxybutynin chloride extended-release tablets should be used with caution in patients who have gastroeso… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common (incidence ≥ 5%) adverse reactions were dry mouth, constipation, diarrhea, headache, somnolence, and dizziness. (6) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety and efficacy of oxybutynin chloride extended-release tablets (5 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 immediate release tablets (5 to 20 mg/day in 199 subjects) was an active comparator.

Adverse reactions reported by ≥ 1% of subjects are shown in Table 1. Table 1: Adverse Drug Reactions Reported by ≥ 1% of Oxybutynin Chloride Extended-Release Tablets-treated Adult Subjects in Five Double-blind, Controlled Clinical Trials of Oxybutynin Chloride Extended-Release Tablets. System/Organ Class Preferred Term Oxybutynin Chloride Extended-Release Tablets 5 to 30 mg/day n = 774 % Oxybutynin Chloride IR 1 Tablets 5 to 20 mg/day n = 199 % Psychiatric Disorders Insomnia 3.0

5.5Nervous System Disorders Headache 7.5

8.0Somnolence 5.6

14.1Dizziness 5.0

16.6Dysgeusia 1.6

1.5Eye Disorders Vision blurred 4.3

9.6Dry eye 3.1

2.5Respiratory , Thoracic and Mediastinal Disorders Cough 1.9

3.0Oropharyngeal pain 1.9

1.5Dry throat 1.7

2.5Nasal dryness 1.7

4.5Gastrointestinal Disorders Dry mouth 34.9

72.4Constipation 8.7

15.1Diarrhea 7.9

6.5Dyspepsia 4.5

6.0Nausea 4.5

11.6Abdominal pain 1.6

2.0Vomiting 1.3

1.5Flatulence 1.2

2.5Gastro-esophageal reflux disease 1.0

0.5Skin and Subcutaneous Tissue Disorders Dry skin 1.8

2.5Pruritus 1.3

1.5Renal and Urinary Disorders Dysuria 1.9

2.0Urinary hesitation 1.9

8.5Urinary retention 1.2

3.0General Disorders and Administration Site Conditions Fatigue 2.6

3.0Investigations Residual urine volume 2 2.3 3.5 1 IR=immediate release 2 The bundled term residual urine volume consists of the preferred terms residual urine volume and residual urine volume increased. The discontinuation rate due to adverse reactions was 4.4% with oxybutynin chloride extended-release tablets compared to 0% with oxybutynin chloride 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.

6.2Postmarketing Experience The following additional adverse reactions have been reported from worldwide postmarketing experience with oxybutynin chloride extended-release tablets. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Infections and Infestations: Urinary tract infection; Psychiatric Disorders: psychotic disorder, agitation, confusional state, hallucinations, memory impairment, abnormal behavior; Nervous System Disorders: convulsions; Eye Disorders: glaucoma; Respiratory, Thoracic and Mediastinal Disorders: nasal congestion; Cardiac Disorders: arrhythmia, tachycardia, palpitations, QT interval prolongation; Vascular Disorders: flushing, hypertension; Skin and Subcutaneous Tissue Disorders: rash; Renal… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 192 words ▾

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

Anticholinergic agents may also antagonize the effects of prokinetic agents, such as metoclopramide. Mean oxybutynin plasma concentrations were approximately 2 fold higher when oxybutynin chloride extended-release tablets 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. Co-administration with other anticholinergic drugs may increase the frequency and/or severity of anticholinergic-like effects.

( 7 ) Co-administration with strong cytochrome P450 (CYP) 3A4 inhibitors (e.g., ketoconazole) increases the systemic exposure of oxybutynin. ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pediatric Use: Oxybutynin chloride extended-release tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing or crushing, or in children under the age of 6 years. ( 8.4 ) Renal or Hepatic Impairment: There have been no studies conducted in patients with renal or hepatic impairment. ( 8.6 , 8.7 )

8.1Pregnancy Risk Summary There are no adequate data on oxybutynin chloride extended-release tablets use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

8.2Lactation Risk Summary There are no data on the presence of oxybutynin in human milk, the effects on the breastfed infant, or the effects of oxybutynin chloride extended-release tablets on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for oxybutynin chloride extended-release tablets and any potential adverse effects on the breastfed child from oxybutynin chloride extended-release tablets or from the underlying maternal condition.

8.4Pediatric Use The safety and efficacy of oxybutynin chloride extended-release tablets were studied in 60 children in a 24-week, open-label, non-randomized trial. Patients were aged 6-15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride. Study results demonstrated that administration of oxybutynin chloride extended-release tablets 5 to 20 mg/day was associated with an increase from baseline in mean urine volume per catheterization from 108 mL to 136 mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 189 mL, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 34% to 51%.

Urodynamic results were consistent with clinical results. Administration of oxybutynin chloride extended-release tablets resulted in an increase from baseline in mean maximum cystometric capacity from 185 mL to 254 mL, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 44 cm H 2 O to 33 cm H 2 O, and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H 2 O) from 60% to 28%. The pharmacokinetics of oxybutynin chloride extended-release tablets in these patients were consistent with those reported for adults [see Clinical Pharmacology (12.3) ] .

Oxybutynin chloride extended-release tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing, or crushing, or in children under the age of 6.

8.5Geriatric Use The rate and severity of anticholinergic effects reported by patients less than 65 years old and those 65 years and older were similar. The pharmacokinetics of oxybutynin chloride extended-release tablets were similar in all patients studied (up to 78 years of age).

8.6Renal Impairment There were no studies conducted with oxybutynin chloride extended-release tablets in patients with renal impairment.

8.7Hepatic Impairment There were no studies conducted with oxybutynin chloride extended-release tablets in patients with hepatic impairment.

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… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 74 words ▾

8.1Pregnancy Risk Summary There are no adequate data on oxybutynin chloride extended-release tablets use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and efficacy of oxybutynin chloride extended-release tablets were studied in 60 children in a 24-week, open-label, non-randomized trial. Patients were aged 6-15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride. Study results demonstrated that administration of oxybutynin chloride extended-release tablets 5 to 20 mg/day was associated with an increase from baseline in mean urine volume per catheterization from 108 mL to 136 mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 189 mL, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 34% to 51%.

Urodynamic results were consistent with clinical results. Administration of oxybutynin chloride extended-release tablets resulted in an increase from baseline in mean maximum cystometric capacity from 185 mL to 254 mL, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 44 cm H 2 O to 33 cm H 2 O, and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H 2 O) from 60% to 28%. The pharmacokinetics of oxybutynin chloride extended-release tablets in these patients were consistent with those reported for adults [see Clinical Pharmacology (12.3) ] .

Oxybutynin chloride extended-release tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing, or crushing, or in children under the age of 6.

🧓 Geriatric Use 45 words ▾

8.5Geriatric Use The rate and severity of anticholinergic effects reported by patients less than 65 years old and those 65 years and older were similar. The pharmacokinetics of oxybutynin chloride extended-release tablets were similar in all patients studied (up to 78 years of age).

🆘 Overdosage 116 words ▾

10 OVERDOSAGE The continuous release of oxybutynin from oxybutynin chloride extended-release tablets should be considered in the treatment of overdosage. Patients should be monitored for at least 24 hours. Treatment should be symptomatic and supportive.

A cathartic may be administered. Overdosage with oxybutynin chloride has been associated with anticholinergic effects including central nervous system excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention. Ingestion of 100 mg oxybutynin chloride in association with alcohol has been reported in a 13-year-old boy who experienced memory loss, and a 34-year-old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine.

Both patients fully recovered with symptomatic treatment.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Oxybutynin relaxes bladder smooth muscle. Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia (antinicotinic effects).

Antimuscarinic activity resides predominantly in the R-isomer. A metabolite, desethyloxybutynin, has pharmacological activity similar to that of oxybutynin in in vitro studies.

12.2Pharmacodynamics In patients with conditions characterized by involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void.

12.3Pharmacokinetics Absorption Following the first dose of oxybutynin chloride extended-release tablets, oxybutynin plasma concentrations rise for 4 to 6 hours; thereafter steady concentrations are maintained for up to 24 hours, minimizing fluctuations between peak and trough concentrations associated with oxybutynin. The relative bioavailabilities of R- and S-oxybutynin from oxybutynin chloride extended-release tablets are 156% and 187%, respectively, compared with oxybutynin. The mean pharmacokinetic parameters for R- and S-oxybutynin are summarized in Table 2.

The plasma concentration-time profiles for R- and S-oxybutynin are similar in shape; Figure 1 shows the profile for R-oxybutynin. Table 2: Mean (SD) R- and S-Oxybutynin Pharmacokinetic Parameters Following a Single Dose of Oxybutynin Chloride Extended-Release Tablets 10 mg (n=43) Parameters (units) R-Oxybutynin S-Oxybutynin C max (ng/mL) 1.0 (0.6) 1.8 (1.0) T max (h) 12.7 (5.4) 11.8 (5.3) t 1/2 (h) 13.2 (6.2) 12.4 (6.1) AUC (0-48) (ng•h/mL) 18.4 (10.3) 34.2 (16.9) AUC inf (ng•h/mL) 21.3 (12.2) 39.5 (21.2) Figure 1: Mean R-oxybutynin plasma concentrations following a single dose of Oxybutynin Chloride Extended-Release Tablets 10 mg and oxybutynin 5 mg administered every 8 hours (n=23 for each treatment) Steady state oxybutynin plasma concentrations are achieved by Day 3 of repeated oxybutynin chloride extended-release tablets dosing, with no observed drug accumulation or change in oxybutynin and desethyloxybutynin pharmacokinetic parameters.

Oxybutynin chloride extended-release tablets steady state pharmacokinetics were studied in 19 children aged 5-15 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. Table 3: Mean ±SD R- and S-Oxybutynin and R- and S-Desethyloxybutynin Pharmacokinetic Parameters in Children Aged 5-15 Following Administration of 5 to 20 mg Oxybutynin Chloride Extended-Release Tablets Once Daily (n=19), All Available Data Normalized to an Equivalent of Oxybutynin Chloride Extended-Release Tablets 5 mg Once Daily R-Oxybutynin S-Oxybutynin R-Desethyloxybutynin S-Desethyloxybutynin C max (ng/mL) T max (h) AUC (ng•h/mL) 0.7 ± 0.4 5.0 12.8 ± 7.0 1.3 ± 0.8 5.0 23.7 ± 14.4 7.8 ± 3.7 5.0 125.1 ± 66.7 4.2 ± 2.3 5.0 73.6 ±

47.7Figure 2: Mean steady state (±SD) R-oxybutynin plasma concentrations following administration of 5 to 20 mg Oxybutynin Chloride Extended-Release Tablets once daily in children aged 5-15. Plot represents all available data normalized to an equivalent of… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 64 words ▾

12.1Mechanism of Action Oxybutynin relaxes bladder smooth muscle. Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia (antinicotinic effects).

Antimuscarinic activity resides predominantly in the R-isomer. A metabolite, desethyloxybutynin, has pharmacological activity similar to that of oxybutynin in in vitro studies.

📦 How Supplied / Storage and Handling 146 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Oxybutynin chloride extended-release tablets USP are available in three dosage strengths, 5 mg (pale yellow round biconvex with orifice), 10 mg (pink round biconvex with orifice), and 15 mg (grey round biconvex with orifice) and are imprinted on one side with "P 5", "P 10", or "P 15" with black ink. Oxybutynin chloride extended-release tablets USP are supplied in bottles of 30, 100 and 500 tablets. 5 mg 30 count bottle NDC 64980-209-03 5 mg 100 count bottle NDC 64980-209-01 5 mg 500 count bottle NDC 64980-209-05 10 mg 100 count bottle NDC 64980-210-01 10 mg 500 count bottle NDC 64980-210-05 15 mg 100 count bottle NDC 64980-211-01 15 mg 500 count bottle NDC 64980-211-05 Storage 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.

📋 Description ~2 min read ▾

11 DESCRIPTION Oxybutynin chloride USP is an antispasmodic, muscarinic antagonist. Each oxybutynin chloride extended-release tablet USP contains 5 mg, 10 mg or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers.

Chemically, oxybutynin chloride is d,l (racemic) 4-diethylamino-2-butynylphenylcyclohexylglycolate hydrochloride. The empirical formula of oxybutynin chloride is C 22 H 31 NO 3 •HCl. Its structural formula is: Oxybutynin chloride USP 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 tablet, USP also contains the following inert ingredients: polyethylene oxide, hypromellose, sodium chloride, butylated hydroxytoluene, ferric oxide (yellow), ferric oxide (red), ferric oxide (black), colloidal silicon dioxide, magnesium stearate, cellulose acetate, polyethylene glycol, titanium dioxide, lactose monohydrate, triacetin, shellac, and propylene glycol. System Components and Performance Oxybutynin chloride extended-release tablets USP 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 bilayer core surrounded by a semipermeable membrane. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice in the semipermeable membrane on the drug-layer 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 push layer to expand. This expansion pushes the suspended 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 bilayer 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. Product meets USP Dissolution Test 6 structural-formula

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Patients should be informed that oxybutynin may produce angioedema that could result in life threatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience swelling of the tongue, edema of the laryngopharynx, or difficulty breathing. Patients should be informed that anticholinergic (antimuscarinic) agents such as oxybutynin chloride extended-release tablets, may produce clinically significant adverse reactions related to anticholinergic activity such as: Urinary retention and constipation Heat prostration due to decreased sweating.

Heat prostration can occur when anticholinergic medicines are administered in the presence of high environmental temperature. Patients should be informed that anticholinergic medicines such as oxybutynin chloride extended-release tablets may produce drowsiness (somnolence), dizziness or blurred vision. Patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until oxybutynin chloride extended-release tablets effects have been determined.

Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin chloride extended-release tablets. Patients should be informed that oxybutynin chloride extended-release tablets should be swallowed whole with the aid of liquids. Patients should not chew, divide, or crush tablets.

The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet. Oxybutynin chloride extended-release tablets should be taken at approximately the same time each day.

For more information call Rising Pharma Holdings, Inc. at 1-844-874-7464. Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J. B.

Chemicals & Pharmaceuticals Ltd.) Mumbai, 400 030, India. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Revised: 05/2025 141691 rising-logo

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Following the first dose of oxybutynin chloride extended-release tablets, oxybutynin plasma concentrations rise for 4 to 6 hours; thereafter steady concentrations are maintained for up to 24 hours, minimizing fluctuations between peak and trough concentrations associated with oxybutynin. The relative bioavailabilities of R- and S-oxybutynin from oxybutynin chloride extended-release tablets are 156% and 187%, respectively, compared with oxybutynin. The mean pharmacokinetic parameters for R- and S-oxybutynin are summarized in Table 2.

The plasma concentration-time profiles for R- and S-oxybutynin are similar in shape; Figure 1 shows the profile for R-oxybutynin. Table 2: Mean (SD) R- and S-Oxybutynin Pharmacokinetic Parameters Following a Single Dose of Oxybutynin Chloride Extended-Release Tablets 10 mg (n=43) Parameters (units) R-Oxybutynin S-Oxybutynin C max (ng/mL) 1.0 (0.6) 1.8 (1.0) T max (h) 12.7 (5.4) 11.8 (5.3) t 1/2 (h) 13.2 (6.2) 12.4 (6.1) AUC (0-48) (ng•h/mL) 18.4 (10.3) 34.2 (16.9) AUC inf (ng•h/mL) 21.3 (12.2) 39.5 (21.2) Figure 1: Mean R-oxybutynin plasma concentrations following a single dose of Oxybutynin Chloride Extended-Release Tablets 10 mg and oxybutynin 5 mg administered every 8 hours (n=23 for each treatment) Steady state oxybutynin plasma concentrations are achieved by Day 3 of repeated oxybutynin chloride extended-release tablets dosing, with no observed drug accumulation or change in oxybutynin and desethyloxybutynin pharmacokinetic parameters.

Oxybutynin chloride extended-release tablets steady state pharmacokinetics were studied in 19 children aged 5-15 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. Table 3: Mean ±SD R- and S-Oxybutynin and R- and S-Desethyloxybutynin Pharmacokinetic Parameters in Children Aged 5-15 Following Administration of 5 to 20 mg Oxybutynin Chloride Extended-Release Tablets Once Daily (n=19), All Available Data Normalized to an Equivalent of Oxybutynin Chloride Extended-Release Tablets 5 mg Once Daily R-Oxybutynin S-Oxybutynin R-Desethyloxybutynin S-Desethyloxybutynin C max (ng/mL) T max (h) AUC (ng•h/mL) 0.7 ± 0.4 5.0 12.8 ± 7.0 1.3 ± 0.8 5.0 23.7 ± 14.4 7.8 ± 3.7 5.0 125.1 ± 66.7 4.2 ± 2.3 5.0 73.6 ±

47.7Figure 2: Mean steady state (±SD) R-oxybutynin plasma concentrations following administration of 5 to 20 mg Oxybutynin Chloride Extended-Release Tablets once daily in children aged 5-15. Plot represents all available data normalized to an equivalent of Oxybutynin Chloride Extended-Release Tablet 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 pharmacologicall… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 38 words ▾

12.2Pharmacodynamics In patients with conditions characterized by involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Oxybutynin chloride extended-release tablets were evaluated for the treatment of patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in three controlled efficacy studies. The majority of patients were Caucasian (89.0%) and female (91.9%) with a mean age of 59 years (range, 18 to 98 years). Entry criteria required that patients have urge or mixed incontinence (with a predominance of urge) as evidenced by ≥ 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 4, 5, and 6 and Figures 3, 4, and 5.

Table 4: Number of Urge Urinary Incontinence Episodes Per Week (Study 1) Study 1 n Oxybutynin chloride extended-release tablets n Placebo Mean Baseline 34 15.9 16

20.9Mean (SD) Change from Baseline† 34 -15.8 (8.9) 16 -7.6 (8.6) 95% Confidence Interval for Difference (-13.6, -2.8) * (Oxybutynin chloride extended- release tablets – Placebo) *The difference between Oxybutynin chloride extended-release tablets and placebo was statistically significant. †Covariate adjusted mean with missing observations set to baseline values Figure 3: Mean Change (± SD) in Urge Urinary Incontinence Episodes Per Week from Baseline (Study 1) The difference between Oxybutynin chloride extended-release tablets and placebo was statistically significant.

Table 5: Number of Urge Urinary Incontinence Episodes Per Week (Study 2) Study 2 n Oxybutynin chloride extended-release tablets n oxybutynin Mean Baseline 53 27.6 52

23.0Mean (SD) Change from Baseline† 53 -17.6 (11.9) 52 -19.4 (11.9) 95% Confidence Interval for Difference (-2.8, 6.5) (Oxybutynin chloride extended-release tablets – oxybutynin) †Covariate adjusted mean with missing observations set to baseline values Figure 4: Mean Change (±SD) in Urge Urinary Incontinence Episodes Per Week from Baseline (Study 2) Table 6: Number of Urge Urinary Incontinence Episodes Per Week (Study 3) Study 3 n Oxybutynin chloride extended-release tablets n oxybutynin Mean Baseline 111 18.9 115

19.5Mean (SD) Change from Baseline† 111 -14.5 (8.7) 115 -13.8 (8.6) 95% Confidence Interval for Difference (Oxybutynin chloride extended-release tablets – oxybutynin) (-3.0, 1.6) ** **The difference between Oxybutynin chloride extended-release tablets and oxybutynin fulfilled the criteria for comparable efficacy. †Covariate adjusted mean with missing observations set to baseline values Figure 5: Mean Change (±SD) in Urge Urinary Incontinence Episodes Per Week from Baseline (Study 3) *The difference between Oxybutynin chloride extended-release tablets and oxybutynin fulfilled the criteria for comparable efficacy. figure-3 figure-4 figure-5

🧪 Nonclinical Toxicology 124 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis 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. Mutagenesis Oxybutynin chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae, and Salmonella typhimurium test systems.

Impairment of Fertility No impairment of fertility was seen in rats at dosages up to 75 mg/kg/day (24 times the MRHD on a mg/m 2 basis) when administered for 2 weeks prior to mating in females and for 9 weeks prior to mating in males.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 121 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis 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. Mutagenesis Oxybutynin chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae, and Salmonella typhimurium test systems.

Impairment of Fertility No impairment of fertility was seen in rats at dosages up to 75 mg/kg/day (24 times the MRHD on a mg/m 2 basis) when administered for 2 weeks prior to mating in females and for 9 weeks prior to mating in males.

📄 Package Label / Principal Display Panel 66 words ▾

———PRINCIPAL DISPLAY PANEL - 5 mg——— Rising ® NDC 64980-209-01 Oxybutynin Chloride Extended-Release Tablets USP 5 mg 100 Tablets Rx only 5mg-100ct-label

PRINCIPAL DISPLAY PANEL - 10 mg——— Rising ® NDC 64980-210-01 Oxybutynin Chloride Extended-Release Tablets USP 10 mg 100 Tablets Rx only 10mg-100ct-label

———PRINCIPAL DISPLAY PANEL - 15 mg——— Rising ® NDC 64980-211-01 Oxybutynin Chloride Extended-Release Tablets USP 15 mg 100 Tablets Rx only 15mg-100ct-label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
13.4K
Units reimbursed last 4 qtrs
455.3K
Gross reimbursed last 4 qtrs
$158.6K
Avg / prescription
$11.88
Avg / unit
$0.3484
Latest quarter Q1 2026
3KRx
Medicaid pays / ea
$0.3484
gross reimbursed
vs
NADAC / ea
$0.0841
acquisition cost
=
Spread
+$0.2643
+314% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
45% FFS 55% MCO
Fee-for-service · 5,963 Rx Managed care · 7,388 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 7,824 units · 100 per 100k residents WA Idaho: 2,650 units · 135 per 100k residents ID Montana: 1,394 units · 123 per 100k residents MT North Dakota: no data reported ND Minnesota: 18,709 units · 326 per 100k residents MN Wisconsin: 5,330 units · 90.2 per 100k residents WI Michigan: 31,980 units · 319 per 100k residents MI New York: 56,594 units · 289 per 100k residents NY Vermont: 504 units · 77.9 per 100k residents VT New Hampshire: no data reported NH Oregon: 1,140 units · 26.9 per 100k residents OR Nevada: 2,100 units · 65.7 per 100k residents NV Wyoming: no data reported WY South Dakota: 3,465 units · 377 per 100k residents SD Iowa: 4,555 units · 142 per 100k residents IA Illinois: 17,810 units · 142 per 100k residents IL Indiana: 9,687 units · 141 per 100k residents IN Ohio: 47,459 units · 403 per 100k residents OH Pennsylvania: 20,522 units · 158 per 100k residents PA New Jersey: 9,102 units · 98.0 per 100k residents NJ Massachusetts: no data reported MA California: 52,588 units · 135 per 100k residents CA Utah: 846 units · 24.8 per 100k residents UT Colorado: 3,263 units · 55.5 per 100k residents CO Nebraska: 2,685 units · 136 per 100k residents NE Missouri: 13,523 units · 218 per 100k residents MO Kentucky: 21,945 units · 485 per 100k residents KY West Virginia: 11,011 units · 622 per 100k residents WV Virginia: 10,800 units · 124 per 100k residents VA Maryland: 7,418 units · 120 per 100k residents MD Connecticut: 4,010 units · 111 per 100k residents CT Rhode Island: 1,088 units · 99.4 per 100k residents RI Arizona: 2,818 units · 37.9 per 100k residents AZ New Mexico: 1,290 units · 61.0 per 100k residents NM Kansas: 2,597 units · 88.3 per 100k residents KS Arkansas: 3,637 units · 119 per 100k residents AR Tennessee: 2,597 units · 36.4 per 100k residents TN North Carolina: 14,048 units · 130 per 100k residents NC South Carolina: 2,790 units · 51.9 per 100k residents SC Delaware: no data reported DE Oklahoma: 9,133 units · 225 per 100k residents OK Louisiana: 9,849 units · 215 per 100k residents LA Mississippi: 3,180 units · 108 per 100k residents MS Alabama: 4,704 units · 92.1 per 100k residents AL Georgia: 5,408 units · 49.0 per 100k residents GA D.C.: 856 units · 126 per 100k residents DC Hawaii: no data reported HI Texas: 8,336 units · 27.3 per 100k residents TX Florida: 14,048 units · 62.1 per 100k residents FL
Units reimbursed · per 100k residents
24.8622
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 622 /100k
2 Kentucky 485 /100k
3 Ohio 403 /100k
4 South Dakota 377 /100k
5 Minnesota 326 /100k
6 Michigan 319 /100k
7 New York 289 /100k
8 Oklahoma 225 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets64980-0209-01 36,943 Rx · $448,181
500 tablets this page64980-0209-05 13,351 Rx · $158,612
30 tablets64980-0209-03 No Medicaid data
Drug total (last 4 qtrs): 50,294 Rx · 1,904,469 units · $606,793 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Oxybutynin Chloride ER (matched by generic name) — the program that covers self-administered drugs. 11 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 ER. CMS lists 2 products for this generic; we show the highest-spend one. 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
$20.49M
Claims incl. refills
803K
Beneficiaries
547.4K
Spend / beneficiary
$37.43
Spend / claim
$25.51
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.
← 64980-0206-12 · Rising 64980-0210-01 · Rising →
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.