What this pack is
DITROPAN XL is the brand name in this record; oxybutynin chloride extended-release tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
DITROPAN XLGeneric nameoxybutynin chloride extended-release tablets
How this medicine works
Oxybutynin and its active metabolite act through antimuscarinic effects related to bladder smooth muscle, while the OROS shell uses osmotic pressure to control release. Mechanism explains product design; it does not prove suitability for an older person or generate an individual plan from symptoms, age or milligrams.
Read source: United States ↗reviewed 2026-08-29More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- DITROPAN XL
- Source-scoped market brand names
- DITROPAN XL · United StatesHistorical regulator record ↗Historical RLD under NDA 020897; 5, 10 and 15 mg are currently listed as Discontinued.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- oxybutynin chloride extended-release tablets
- Dosage-form class
- Oxybutynin chloride osmotic extended-release oral tablets: 5 mg, 10 mg or 15 mg per tablet; swallow whole and do not chew, divide or crush; not an immediate-release tablet, syrup or transdermal patch
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
3 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Dated 2021 U.S. FDA label
Oxybutynin chloride 5 mg per tablet; U.S. originator RLD discontinued
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020897 / Product 001
- Form and route
- DITROPAN XL oxybutynin chloride extended-release oral tablet · oral (intact osmotic extended-release tablet identity field)
- Container
- historical product record; exact retail pack count not inferred here
- Listing review
- Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
- oxybutynin chloride
- 5 mglabelled amount per tablet; not an individual's tablet count, timing, adjustment or switching instruction
- Package
- 1 FDA historical product identity (not a one-tablet pack)
- Labelled appearance
- pale yellow · round, biconvex, unscored extended-release tablet; do not chew, divide or crush · imprint 5 XLUnscored; do not infer permission to split it
United States label · Dated 2021 U.S. FDA label
Oxybutynin chloride 10 mg per tablet; U.S. originator RLD discontinued
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020897 / Product 002
- Form and route
- DITROPAN XL oxybutynin chloride extended-release oral tablet · oral (intact osmotic extended-release tablet identity field)
- Container
- historical product record; exact retail pack count not inferred here
- Listing review
- Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
- oxybutynin chloride
- 10 mglabelled amount per tablet; not an individual's tablet count, timing, adjustment or switching instruction
- Package
- 1 FDA historical product identity (not a one-tablet pack)
- Labelled appearance
- pink · round, biconvex, unscored extended-release tablet; do not chew, divide or crush · imprint 10 XLUnscored; do not infer permission to split it
United States label · Dated 2015 U.S. FDA label
Oxybutynin chloride 15 mg per tablet; U.S. originator RLD discontinued
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020897 / Product 003
- Form and route
- DITROPAN XL oxybutynin chloride extended-release oral tablet · oral (intact osmotic extended-release tablet identity field)
- Container
- historical product record; exact retail pack count not inferred here
- Listing review
- Cited product evidence reviewed 2026-08-29; actual marketing, stock and availability are not established.
- oxybutynin chloride
- 15 mglabelled amount per tablet; not an individual's tablet count, timing, adjustment or switching instruction
- Package
- 1 FDA historical product identity (not a one-tablet pack)
- Labelled appearance
- grey · round, biconvex, unscored extended-release tablet; do not chew, divide or crush · imprint 15 XLUnscored; do not infer permission to split it
PACKAGE-VISUAL STATUS
Colour, shape, imprint and historical RLD identity are verified for three strengths; no generic or repackaged image is presented as the originator pack
The 2021 FDA label lists pale-yellow 5 mg ‘5 XL’ and pink 10 mg ‘10 XL’ tablets; the 2015 label also lists grey 15 mg ‘15 XL’. No official display panels matched one-to-one to all three historical originator retail packs were obtained, so the page provides text identity cards and enlarged labels without substituting retail, pill-database or generic-product images.
LABEL READING · NOT A PRESCRIPTION
DITROPAN XL label reading: do not split or crush; the shell may pass in stool
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
The FDA label says to swallow the tablet whole with liquids and not chew, divide or crush it. Medicine is held in a nonabsorbable osmotic shell that may pass in stool after release; seeing something tablet-like does not justify taking an extra tablet.
- 5, 10 and 15 mg are labelled amounts per tablet, not an individual's tablet count. Although two 5 mg numbers add to 10 mg, that does not permit self-assembling tablets, changing an amount, replacing a 10 mg product or copying another person's prescription.
- Keep the tablet intact; do not split, cut, chew, dissolve or crush it. For swallowing difficulty, take the exact pack and prescription to a pharmacist or prescriber instead of disrupting extended release or self-switching to syrup, immediate-release tablets or a patch.
- Dry mouth, constipation, inability to urinate, drowsiness, dizziness, blurred vision, confusion or hallucinations may relate to anticholinergic effects. Older adults, people with cognitive impairment and those using sleeping, allergy, nausea, bladder or other anticholinergic medicines need priority review of the complete medicine list.
- Swelling of the face, lips, tongue or throat or difficulty breathing needs emergency help. Reduced sweating, high temperature or mental-status change in heat can also be serious. Severe constipation, distension, inability to pass stool or gas, or urinary retention needs prompt medical assessment.
- Urinary retention, gastric retention or severe reduced gastrointestinal motility and uncontrolled narrow-angle glaucoma are labelled contraindications. Myasthenia gravis, autonomic neuropathy, reflux disease, liver or kidney problems and dementia medicines also need to be disclosed to the professional.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkFDA · United States · Regulatory product record or label archive · 2026-08-29
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 3
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeFDA: DITROPAN XL oxybutynin chloride extended-release tablet U.S. prescribing information (NDA 020897; dated 2021 label) ↗reviewed 2026-08-29
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA: historical DITROPAN XL oxybutynin chloride extended-release tablet prescribing information (2015; includes the 15 mg appearance record) ↗Historical public record · reviewed 2026-08-29
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA Drugs@FDA: DITROPAN XL NDA 020897 application, RLD identity and discontinued status ↗reviewed 2026-08-29
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about DITROPAN XL (oxybutynin chloride extended-release tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
DITROPAN XL is the brand in this record and oxybutynin chloride extended-release tablets is the active-ingredient name. Check both with the dosage form (Oxybutynin chloride osmotic extended-release oral tablets: 5 mg, 10 mg or 15 mg per tablet; swallow whole and do not chew, divide or crush; not an immediate-release tablet, syrup or transdermal patch) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- FDA: DITROPAN XL oxybutynin chloride extended-release tablet U.S. prescribing information (NDA 020897; dated 2021 label) ↗reviewed 2026-08-29
- FDA: historical DITROPAN XL oxybutynin chloride extended-release tablet prescribing information (2015; includes the 15 mg appearance record) ↗Historical public record · reviewed 2026-08-29
- FDA Drugs@FDA: DITROPAN XL NDA 020897 application, RLD identity and discontinued status ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How DITROPAN XL works: muscarinic blockade and osmotic extended release are two different layers
- The same mechanism used for bladder urgency can also affect the mouth, bowel, eyes, urination, sweating and central nervous system, so a ‘bladder medicine’ label must not hide whole-body symptoms or the complete medicine list.
- Extended-release tablets, immediate-release oxybutynin, syrup and patches have different release and absorption paths. Do not self-combine, alternate or exchange them by matching milligrams, or add another bladder medicine such as VESIcare or MYRBETRIQ without review.
- Whole-genome screening is not a universal prerequisite set by this site for this choice. Review more directly requires the exact diagnosis and goals, cognition and fall risk, urinary and bowel status, glaucoma history, liver and kidney function, and all medicines.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- FDA: DITROPAN XL oxybutynin chloride extended-release tablet U.S. prescribing information (NDA 020897; dated 2021 label) ↗reviewed 2026-08-29
- FDA: historical DITROPAN XL oxybutynin chloride extended-release tablet prescribing information (2015; includes the 15 mg appearance record) ↗Historical public record · reviewed 2026-08-29
- FDA Drugs@FDA: DITROPAN XL NDA 020897 application, RLD identity and discontinued status ↗reviewed 2026-08-29
- FDA: DITROPAN XL NDA 020897 original approval and medical review material (1998) ↗reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
DITROPAN XLoxybutynin chloride extended-release tablets
This page links to public primary-source material for DITROPAN XL. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
FDA approved DITROPAN XL 5 mg and 10 mg
The FDA original approval material links the two osmotic extended-release strengths to NDA 020897, ALZA and overactive-bladder symptoms.
FDA: DITROPAN XL NDA 020897 original approval and medical review material (1998) ↗FDA approved the 15 mg product
The current Orange Book archive retains Product 003, 15 mg, RLD identity and this approval date; status is now Discontinued.
FDA Drugs@FDA: DITROPAN XL NDA 020897 application, RLD identity and discontinued status ↗Most recent dated FDA label node reviewed
The 2021 S-038 label lists 5 mg and 10 mg and supports whole-tablet, anticholinergic CNS, angioedema and heat-prostration reading boundaries; it does not prove continued marketing.
FDA: DITROPAN XL oxybutynin chloride extended-release tablet U.S. prescribing information (NDA 020897; dated 2021 label) ↗Current U.S. product status reviewed
All three 5, 10 and 15 mg RLD products under NDA 020897 are listed as Discontinued. This is the site's review date, not the discontinuation decision date.
FDA Drugs@FDA: DITROPAN XL NDA 020897 application, RLD identity and discontinued status ↗
MARKET SCOPE
Market-record boundary
United States
Historical RLD archive; 5, 10 and 15 mg are discontinuedThe page provides three text identity cards, dated labels and historical review routes; it does not establish stock, purchase, authenticity, interchangeability or individual suitability.
Mainland China, EU, Japan and other markets
Current market records not establishedNo local brand, approval, pack, supply or interchangeability is inferred from the historical U.S. brand, NDA, RLD identity, generic name, milligrams or appearance.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Does something tablet-like in stool mean the medicine was not absorbed?
Not necessarily. The FDA label says the nonabsorbable release shell may pass in stool. Do not take an extra tablet because of this; contact a professional for unusual symptom control, persistent concern or serious gastrointestinal symptoms.
Can a 10 mg tablet be split to make 5 mg?
Do not do this yourself. DITROPAN XL is an unscored osmotic extended-release tablet, and the FDA label requires swallowing whole without chewing, dividing or crushing. Any adjustment requires review of the exact prescription and available product.
Can it be taken with VESIcare, MYRBETRIQ or immediate-release oxybutynin?
The site cannot decide from names alone. Ingredients, actions and adverse-effect boundaries differ; duplicate anticholinergic effects, urinary retention, constipation, drowsiness, cognition and fall risk require professional review of the complete medicine list, diagnosis and individual context.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.