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Medicine

Oxybutynin 5 mg tablet

Oxybutynin · Oral
Available on requestPrescription onlyUS FDAGeneric name

Oxybutynin 5 mg tablet is a generic prescription medicine for oral use, made by 28 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…

Key facts

Active ingredient (INN)
Oxybutynin
Brand
Sold under the generic name
Strength
5 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 500 tablets, 1000 tablets and 121 more
Manufacturers
Strides PharmaIndiaAvet PharmaceuticalsIndiaRising Pharma HoldingsANI PharmaceuticalsKVK-TechLeading PharmaTeva PharmaceuticalsUpsher-Smith LaboratoriesTruPharmaVerityrx28 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F).
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
30 September 1990
Identifiers
RxCUI 863664, 863758, 863636DailyMed set ID 73d715dc-868d-4194-b668-4c39ababa698, 39a2d144-0c10-4aec-9fa4-0adc24b332eb, 7c497c6c-2448-2c80-e053-2991aa0ab8c7 +37NDC 23155-913, 50090-4622, 52817-260 +37Application ANDA211682, ANDA209335, ANDA210125 +7

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 28 labelers. The register lists 124 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet in 1 bottle23155-810-01Avet PharmaceuticalsIndia31 January 2022
500 tablet in 1 bottle23155-810-05Avet PharmaceuticalsIndia31 January 2022
1000 tablet in 1 bottle23155-810-10Avet PharmaceuticalsIndia31 January 2022
100 tablet in 1 bottle, plastic23155-913-01Avet PharmaceuticalsIndia1 June 2026
500 tablet in 1 bottle, plastic23155-913-05Avet PharmaceuticalsIndia1 June 2026
1000 tablet in 1 bottle, plastic23155-913-10Avet PharmaceuticalsIndia1 June 2026
100 tablet in 1 bottle, plastic64380-162-01Strides PharmaIndia30 September 2022
500 tablet in 1 bottle, plastic64380-162-02Strides PharmaIndia4 April 2022
1000 tablet in 1 bottle, plastic64380-162-03Strides PharmaIndia30 September 2022
60 tablet in 1 bottle64380-781-03Strides PharmaIndia20 December 2024
90 tablet in 1 bottle64380-781-05Strides PharmaIndia20 December 2024
100 tablet in 1 bottle64380-781-06Strides PharmaIndia20 December 2024
500 tablet in 1 bottle64380-781-07Strides PharmaIndia20 December 2024
1000 tablet in 1 bottle64380-781-08Strides PharmaIndia20 December 2024
100 tablet in 1 bottle64980-431-01Rising Pharma Holdings1 February 2018
1000 tablet in 1 bottle64980-431-10Rising Pharma Holdings1 February 2018
500 tablet in 1 bottle64980-431-50Rising Pharma Holdings1 February 2018
100 tablet in 1 bottle64980-679-01Rising Pharma Holdings18 July 2026
1000 tablet in 1 bottle64980-679-10Rising Pharma Holdings27 April 2026
500 tablet in 1 bottle64980-679-50Rising Pharma Holdings27 April 2026
100 tablet in 1 bottle70954-005-10ANI Pharmaceuticals15 November 2017
500 tablet in 1 bottle70954-005-20ANI Pharmaceuticals15 November 2017
1000 tablet in 1 bottle70954-005-30ANI Pharmaceuticals15 November 2017
100 blister pack in 1 carton / 1 tablet in 1 blister pack70954-005-50ANI Pharmaceuticals20 August 2021
100 tablet in 1 bottle, plastic10702-201-01KVK-Tech22 December 2017
1000 tablet in 1 bottle, plastic10702-201-10KVK-Tech22 December 2017
500 tablet in 1 bottle, plastic10702-201-50KVK-Tech22 December 2017
100 tablet in 1 bottle69315-182-01Leading Pharma1 November 2019
500 tablet in 1 bottle69315-182-05Leading Pharma1 November 2019
1000 tablet in 1 bottle69315-182-10Leading Pharma1 November 2019
100 tablet in 1 bottle50111-456-01Teva Pharmaceuticals30 September 1990
500 tablet in 1 bottle50111-456-02Teva Pharmaceuticals30 September 1990
1000 tablet in 1 bottle50111-456-03Teva Pharmaceuticals30 September 1990
100 tablet in 1 bottle, plastic52817-260-10TruPharma1 January 2019
500 tablet in 1 bottle, plastic52817-260-50TruPharma1 January 2019
100 tablet in 1 bottle0832-0038-00Upsher-Smith Laboratories7 November 2011
1000 tablet in 1 bottle0832-0038-10Upsher-Smith Laboratories7 November 2011
500 tablet in 1 bottle0832-0038-50Upsher-Smith Laboratories7 November 2011
1 tablet in 1 pouch83939-0022-1Verityrx3 November 2025
50 pouch in 1 box, unit-dose / 1 tablet in 1 pouch83939-0022-2Verityrx3 November 2025

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 16 July 1975Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

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 Oxybutynin

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Oxybutynin 5 mg tablet for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.