Home › NDC Lookup › Ingredients › Oxybutynin Chloride › 51407-0099-01
Oxybutynin Chloride 5 mg Tablet, 100-count — NDC 51407-0099-01 package photo

Oxybutynin Chloride 5 mg Tablet, 100-count

by Golden State Medical Supply, Inc. · 100 TABLET in 1 BOTTLE (51407-099-01)
NDC 51407-0099-01
🏷️ FDA NDC (as labeled) 51407-099-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.1412/unit — full pricing hub ↓
Also comes in: 500 tablets 51407-0099-05
Rx only Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 51407-099-01
Product NDC 51407-099
11-digit billing NDC 51407009901
NCPDP billing unit EA — each (per item)
RxCUI 863664
UNII L9F3D9RENQ
Application # ANDA209823
SPL Set ID 6f409d7f-b064-1363-e053-2a91aa0a3a14
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 2017-10-23
Route ORAL
Dosage form TABLET
Substance OXYBUTYNIN CHLORIDE
GPI-14 54100045200330
GPI class Oxybutynin Chloride
GCN Seq No 004929
GCN 19380
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 5 MG TABLET
FDB brand name Oxybutynin Chloride
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 51407-099-01 — 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 → 51407-0099-01. 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.

🏭 Manufacturer & labeler

LabelerGolden State Medical Supply, Inc.
Application holderNOVITIUM PHARMA LLC
FDA applicationANDA209823 (ANDA)
Labeler code51407
First marketedOct 2017
Product typeHuman Prescription Drug
Portfolio661 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.

🩺 Clinical

Label name OXYBUTYNIN 5 MG TABLET Ingredient Oxybutynin Chloride
📖 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.

💊 What it looks like

Color white
ShapeRound
Imprintn005
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 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 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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.

4 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.

💲 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 $14.12 / 100 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Oxybutynin Chloride 5 mg 00832-0038-00 Upsher-Smith 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 00904-7027-61 Major 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 10702-0201-01 KVK-Tech, 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 23155-0810-01 Heritage 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 50111-0456-01 Teva 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 52817-0260-10 TruPharma 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 60687-0899-01 American 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 64380-0162-01 Strides 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 64980-0431-01 RISING 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 69315-0182-01 Leading 100 tablets $0.047 AB Availability likely —
Oxybutynin Chloride 5 mg 70954-0005-10 ANI 100 tablets $0.047 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 mgthis 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 mg 71335-0519-01 Bryant 30 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 —
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

🏛️
2017
On the market since
Oct 2017
📍
2026
Currently FDA-listed
9 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.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Oxybutynin Chloride — the ingredient across all brands.

Top reported reactions

Fatigue729
Nausea602
Fall579
Headache557
Diarrhoea507
Pain481
Urinary Tract Infection446

Reporter sex

8,714 reports
Male · 29%
Female · 71%
Unknown · 0%

Serious outcomes

Hospitalization2,547
Death550
Disabling140
Life-threatening129
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 754 290
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51407-0099-01 You're viewing this 100 TABLET in 1 BOTTLE (51407-099-01) 2018-06-07 Active
51407-0099-05 500 TABLET in 1 BOTTLE (51407-099-05) 2018-06-07 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 51407-0099-01?
NDC 51407-0099-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 51407-0099-01 and NDC 51407-0099-05?
Both are Oxybutynin Chloride 5 mg Tablet — the drug itself is identical. NDC 51407-0099-01 is the 100-count package, while NDC 51407-0099-05 is the 500 tablets package.
What NDC number is used to bill for this package of Oxybutynin Chloride 5 mg Tablet?
Bill NDC 51407-0099-01 — the 11-digit billing format is 51407009901. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 51407-099-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51407-0099-01, written without dashes as 51407009901. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51407-0099-01, the first segment (51407) is the labeler code FDA assigned to Golden State Medical Supply, Inc.; the middle segment (0099) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Golden State Medical Supply, Inc.. 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 1 other package presentation of this same product, including 500 tablets (51407-0099-05). 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?
Golden State Medical Supply, Inc. 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 37 words ▾

INDICATIONS & 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 78 words ▾

DOSAGE & 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 55 words ▾

CONTRAINDICATIONS Oxybutynin chloride tablets are 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 tablets are 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 14.0% Headache 7.5% Eye Disorders Blurred vision 9.6% Gastrointestinal Disorders Dry mouth 71.4% Constipation 15.1% Nausea 11.6% Dyspepsia 6.0% Renal and Urinary Disorders Urinary Hesitation 8.5% Urinary Retention 6.0% 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 : kerato conjunctivitis 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 oral oxybutynin chloride: Psychiatric Disorders : psychotic disorder, agitation, hallucinations, memory impairment; Nervous System Disorders : convulsions; Eye Disorders : cycloplegia, mydriasis, glaucoma; Cardiac Disorders : tachycardia, QT interval prolongation, chest discomfort; Gastrointestinal Disorders : decreased gastrointestinal motility, frequent bowel movements; 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; Metabolism and Nutrition Disorders : anorexia; Respiratory, Thoracic and Mediastinal Disorders : dysphonia.

🔄 Drug Interactions 155 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.

Anticholinergic agents may also antagonize the effects of prokinetic agents, such as metoclopramide. Mean oxybutynin chloride plasma concentrations were approximately 3 to 4 fold higher when oxybutynin was administered with ketoconazole, a potent CYP3A4 inhibitor. Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., C max and AUC).

The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are co-administered.

🤰 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.

🧓 Geriatric Use 124 words ▾

Geriatric Use Clinical studies of oxybutynin chloride did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between healthy elderly and younger patients; however, a lower initial starting dose of 2.5 mg given 2 or 3 times a day has been recommended for the frail elderly due to a prolongation of the elimination half-life from 2 to 3 hours to 5 hours . 2,3,4 In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 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) 35.0 (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 * (ng/mL) 6.1 ± 3.2 10.1 ± 7.5 55.4 ± 17.9 28.2 ±

10.0T max (hr) 1.0 1.0 2.0

2.0AUC † (ng•hr/mL) 19.8 ± 7.4 28.4 ± 12.7 238.8 ± 77.6 119.5 ± 50.7 *Reflects C max for pooled data † AUC 0-end of dosing interval Figure 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…

📦 How Supplied / Storage and Handling 70 words ▾

HOW SUPPLIED Oxybutynin Chloride Tablets, USP 5 mg are white, round, biconvex tablets debossed with “n005” on one side and bisect on the other side. They are supplied as follows: NDC 51407- 099 -01 Bottles of 100 Tablets NDC 51407- 099 -05 Bottles of 500 Tablets Pharmacist: Dispense in tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 101 words ▾

DESCRIPTION Each scored oxybutynin chloride tablet, USP contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d, l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The molecular formula of oxybutynin chloride is C 22 H 31 NO 3 •HCl.

The structural formula appears below: Oxybutynin chloride, USP is a white crystalline solid with a molecular weight of 393.95. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride Tablets, USP also contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose.

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

STRUCTURE

💬 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51407-0093-90 · Golden 51407-0100-30 · Golden →
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.