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Medicine

Tolterodine 2 mg extended-release capsule

Tolterodine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Tolterodine 2 mg extended-release capsule is a generic prescription medicine for oral use, made by 10 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). Protect from light.

Key facts

Active ingredient (INN)
Tolterodine
Brand
Sold under the generic name
Strength
2 mg
Dosage form
Extended-release capsule
Route
Oral
Packs
500 capsules, 30 capsules, 90 capsules and 24 more
Manufacturers
Torrent PharmaceuticalsIndiaAjanta PharmaIndiaCamber PharmaceuticalsIndiaUnichem LaboratoriesIndiaANI PharmaceuticalsGolden State Medical SupplySlate Run PharmaceuticalsTeva PharmaceuticalsAmerican Health PackagingMajor Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F). Protect from light.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
G04BD07 Tolterodine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
11 August 2015
Identifiers
RxCUI 855182, 855189DailyMed set ID 973f98b5-4e8a-42d9-ac69-d4333d21c362, e4b9ef09-c750-4e35-96fc-e759ba4849d8, db6e0b6d-0ce5-41d7-881f-881c11f530a4 +7NDC 0093-7163, 0904-7574, 13668-189 +7Application ANDA079141, ANDA204562, ANDA203016 +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

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
500 capsule, extended release in 1 bottle27241-191-05Ajanta PharmaIndia25 June 2020
30 capsule, extended release in 1 bottle27241-191-30Ajanta PharmaIndia25 June 2020
90 capsule, extended release in 1 bottle27241-191-90Ajanta PharmaIndia25 June 2020
500 capsule, extended release in 1 bottle31722-607-05Camber PharmaceuticalsIndia2 June 2017
30 capsule, extended release in 1 bottle31722-607-30Camber PharmaceuticalsIndia2 June 2017
90 capsule, extended release in 1 bottle31722-607-90Camber PharmaceuticalsIndia2 June 2017
500 capsule, extended release in 1 bottle13668-189-05Torrent PharmaceuticalsIndia11 August 2015
30 capsule, extended release in 1 bottle13668-189-30Torrent PharmaceuticalsIndia11 August 2015
100 capsule, extended release in 1 carton13668-189-74Torrent PharmaceuticalsIndia11 August 2015
90 capsule, extended release in 1 bottle13668-189-90Torrent PharmaceuticalsIndia11 August 2015
500 capsule, extended release in 1 bottle29300-306-05Unichem LaboratoriesIndia1 October 2024
30 capsule, extended release in 1 bottle29300-306-13Unichem LaboratoriesIndia1 October 2024
90 capsule, extended release in 1 bottle29300-306-19Unichem LaboratoriesIndia1 October 2024
30 capsule, extended release in 1 bottle43975-322-03ANI Pharmaceuticals29 August 2019
90 capsule, extended release in 1 bottle43975-322-09ANI Pharmaceuticals29 August 2019
500 capsule, extended release in 1 bottle43975-322-50ANI Pharmaceuticals29 August 2019
500 capsule, extended release in 1 bottle70436-160-02Slate Run Pharmaceuticals12 April 2021
30 capsule, extended release in 1 bottle70436-160-04Slate Run Pharmaceuticals12 April 2021
90 capsule, extended release in 1 bottle70436-160-06Slate Run Pharmaceuticals12 April 2021
500 capsule, extended release in 1 bottle0093-7163-05Teva Pharmaceuticals20 March 2017
30 capsule, extended release in 1 bottle0093-7163-56Teva Pharmaceuticals20 March 2017
90 capsule, extended release in 1 bottle0093-7163-98Teva Pharmaceuticals20 March 2017
30 blister pack in 1 box, unit-dose / 1 capsule, extended release in 1 blister pack60687-319-21American Health Packaging14 August 2017
500 capsule, extended release in 1 bottle51407-739-05Golden State Medical Supply11 August 2023
30 capsule, extended release in 1 bottle51407-739-30Golden State Medical Supply11 August 2023
90 capsule, extended release in 1 bottle51407-739-90Golden State Medical Supply11 August 2023
30 blister pack in 1 carton / 1 capsule, extended release in 1 blister pack0904-7574-04Major Pharmaceuticals24 June 2026

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 25 March 1998Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
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 Tolterodine

Clinical summary

Tolterodine is a cholinergic muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. It is available as extended-release capsules and tablets for oral use. MedsAcross supplies Tolterodine 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 Tolterodine

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

Data sources

Need Tolterodine 2 mg extended-release capsule 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.