Medicine
Oxybutynin 5 mg extended-release tablet
Oxybutynin 5 mg extended-release tablet is a generic prescription medicine for oral use, made by 19 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F). Protect from…
Key facts
- Active ingredient (INN)
- Oxybutynin
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 52 more
- Manufacturers
- Zydus LifesciencesIndiaAccord HealthcareIndiaAjanta PharmaIndiaAphena Pharma Solutions - TennesseeA-S Medication SolutionsAmneal PharmaceuticalsRising Pharma HoldingsAdvagen PharmaLannettBryant Ranch Prepack19 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F). Protect from moisture and humidity.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G04BD04 Oxybutynin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 March 2009
- Identifiers
- RxCUI 863636, 863619, 863628 +1DailyMed set ID e985e201-2fb3-4781-9790-a1a3db1ae2a1, 5b432aae-8a9d-8846-e063-6394a90a3b0d, 3f7da2a3-ca46-d3e8-e063-6294a90abef3 +20NDC 43353-285, 67296-2335, 67046-1599 +20Application ANDA078503, ANDA202332, ANDA211655 +4
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
A sample of 40 packs from 19 labelers. The register lists 55 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated, extended release in 1 bottle | 68382-255-01 | Zydus LifesciencesIndia | 10 August 2017 |
| 500 tablet, film coated, extended release in 1 bottle | 68382-255-05 | Zydus LifesciencesIndia | 10 August 2017 |
| 30 tablet, film coated, extended release in 1 bottle | 68382-255-06 | Zydus LifesciencesIndia | 10 August 2017 |
| 60 tablet, film coated, extended release in 1 bottle | 68382-255-14 | Zydus LifesciencesIndia | 10 August 2017 |
| 90 tablet, film coated, extended release in 1 bottle | 68382-255-16 | Zydus LifesciencesIndia | 10 August 2017 |
| 10 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack | 68382-255-77 | Zydus LifesciencesIndia | 10 August 2017 |
| 100 tablet, film coated, extended release in 1 bottle | 70771-1086-1 | Zydus LifesciencesIndia | 10 August 2017 |
| 30 tablet, film coated, extended release in 1 bottle | 70771-1086-3 | Zydus LifesciencesIndia | 10 August 2017 |
| 10 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack | 70771-1086-4 | Zydus LifesciencesIndia | 10 August 2017 |
| 500 tablet, film coated, extended release in 1 bottle | 70771-1086-5 | Zydus LifesciencesIndia | 10 August 2017 |
| 60 tablet, film coated, extended release in 1 bottle | 70771-1086-6 | Zydus LifesciencesIndia | 10 August 2017 |
| 90 tablet, film coated, extended release in 1 bottle | 70771-1086-9 | Zydus LifesciencesIndia | 10 August 2017 |
| 100 tablet, extended release in 1 bottle | 16729-317-01 | Accord HealthcareIndia | 14 December 2016 |
| 500 tablet, extended release in 1 bottle | 16729-317-16 | Accord HealthcareIndia | 30 March 2017 |
| 100 tablet, extended release in 1 bottle | 27241-155-04 | Ajanta PharmaIndia | 28 February 2019 |
| 500 tablet, extended release in 1 bottle | 27241-155-08 | Ajanta PharmaIndia | 28 February 2019 |
| 100 tablet, extended release in 1 bottle | 72888-030-01 | Advagen Pharma | 27 October 2020 |
| 500 tablet, extended release in 1 bottle | 72888-030-05 | Advagen Pharma | 10 July 2024 |
| 30 tablet, extended release in 1 bottle | 65162-371-03 | Amneal Pharmaceuticals | 2 November 2015 |
| 90 tablet, extended release in 1 bottle | 65162-371-09 | Amneal Pharmaceuticals | 2 November 2015 |
| 100 tablet, extended release in 1 bottle | 65162-371-10 | Amneal Pharmaceuticals | 2 November 2015 |
| 500 tablet, extended release in 1 bottle | 65162-371-50 | Amneal Pharmaceuticals | 2 November 2015 |
| 90 tablet, extended release in 1 bottle | 62135-507-90 | Chartwell RX | 3 March 2023 |
| 100 tablet, extended release in 1 bottle | 62175-270-37 | Lannett | 1 March 2009 |
| 500 tablet, extended release in 1 bottle | 62175-270-41 | Lannett | 1 March 2009 |
| 100 tablet, extended release in 1 bottle | 64980-209-01 | Rising Pharma Holdings | 27 September 2016 |
| 30 tablet, extended release in 1 bottle | 64980-209-03 | Rising Pharma Holdings | 29 March 2022 |
| 500 tablet, extended release in 1 bottle | 64980-209-05 | Rising Pharma Holdings | 29 March 2022 |
| 90 tablet, extended release in 1 bottle | 50090-5822-0 | A-S Medication Solutions | 20 October 2021 |
| 30 tablet, extended release in 1 bottle | 50090-5822-1 | A-S Medication Solutions | 19 July 2023 |
| 90 tablet, extended release in 1 bottle | 50090-6840-0 | A-S Medication Solutions | 27 November 2023 |
| 30 tablet, extended release in 1 bottle | 50090-6840-1 | A-S Medication Solutions | 27 November 2023 |
| 30 tablet, extended release in 1 bottle | 43353-282-30 | Aphena Pharma Solutions - Tennessee | 2 March 2017 |
| 60 tablet, extended release in 1 bottle | 43353-282-53 | Aphena Pharma Solutions - Tennessee | 2 March 2017 |
| 90 tablet, extended release in 1 bottle | 43353-282-60 | Aphena Pharma Solutions - Tennessee | 2 March 2017 |
| 180 tablet, extended release in 1 bottle | 43353-282-80 | Aphena Pharma Solutions - Tennessee | 31 May 2023 |
| 30 tablet, extended release in 1 bottle | 43353-285-30 | Aphena Pharma Solutions - Tennessee | 2 March 2017 |
| 60 tablet, extended release in 1 bottle | 43353-285-53 | Aphena Pharma Solutions - Tennessee | 2 March 2017 |
| 90 tablet, extended release in 1 bottle | 43353-285-60 | Aphena Pharma Solutions - Tennessee | 2 March 2017 |
| 30 tablet, extended release in 1 bottle | 63629-9689-1 | Bryant Ranch Prepack | 21 June 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Oxybutynin
Clinical summary
Oxybutynin is a cholinergic muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency. It is available as extended-release tablets, tablets and oral solution for transdermal use. MedsAcross supplies Oxybutynin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about OxybutyninFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- OXYTROL prescribing information (Allergan) · U.S. National Library of Medicine, DailyMed
- Kentera (previously Oxybutynin Nicobrand): European public assessment report (EPAR) · European Medicines Agency
Need Oxybutynin 5 mg extended-release tablet for your hospital or patient?
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