Medicine
Tolterodine 4 mg extended-release capsule
Tolterodine 4 mg extended-release capsule is a generic prescription medicine for oral use, made by 11 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 tolterodine tartrate extended-release capsules, USP at 20° to 25°C (68°…
Key facts
- Active ingredient (INN)
- Tolterodine
- Brand
- Sold under the generic name
- Strength
- 4 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 500 capsules, 30 capsules, 90 capsules and 26 more
- Manufacturers
- Torrent PharmaceuticalsIndiaAjanta PharmaIndiaCamber PharmaceuticalsIndiaUnichem LaboratoriesIndiaANI PharmaceuticalsGolden State Medical SupplySlate Run PharmaceuticalsTeva PharmaceuticalsA-S Medication SolutionsAmerican Health Packaging
- Origin register
- US FDA, United States
- Storage
- Store tolterodine tartrate extended-release capsules, USP at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°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 855189, 855182DailyMed set ID fd6c8b3d-a52a-4418-aa9c-0297db6c0807, db6e0b6d-0ce5-41d7-881f-881c11f530a4, 973f98b5-4e8a-42d9-ac69-d4333d21c362 +8NDC 50090-3475, 13668-190, 0093-7164 +8Application ANDA079141, ANDA203016, ANDA216917 +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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 500 capsule, extended release in 1 bottle | 27241-192-05 | Ajanta PharmaIndia | 25 June 2020 |
| 30 capsule, extended release in 1 bottle | 27241-192-30 | Ajanta PharmaIndia | 25 June 2020 |
| 90 capsule, extended release in 1 bottle | 27241-192-90 | Ajanta PharmaIndia | 25 June 2020 |
| 500 capsule, extended release in 1 bottle | 31722-608-05 | Camber PharmaceuticalsIndia | 2 June 2017 |
| 30 capsule, extended release in 1 bottle | 31722-608-30 | Camber PharmaceuticalsIndia | 2 June 2017 |
| 90 capsule, extended release in 1 bottle | 31722-608-90 | Camber PharmaceuticalsIndia | 2 June 2017 |
| 500 capsule, extended release in 1 bottle | 13668-190-05 | Torrent PharmaceuticalsIndia | 11 August 2015 |
| 30 capsule, extended release in 1 bottle | 13668-190-30 | Torrent PharmaceuticalsIndia | 11 August 2015 |
| 100 capsule, extended release in 1 carton | 13668-190-74 | Torrent PharmaceuticalsIndia | 11 August 2015 |
| 90 capsule, extended release in 1 bottle | 13668-190-90 | Torrent PharmaceuticalsIndia | 11 August 2015 |
| 500 capsule, extended release in 1 bottle | 29300-307-05 | Unichem LaboratoriesIndia | 1 October 2024 |
| 30 capsule, extended release in 1 bottle | 29300-307-13 | Unichem LaboratoriesIndia | 1 October 2024 |
| 90 capsule, extended release in 1 bottle | 29300-307-19 | Unichem LaboratoriesIndia | 1 October 2024 |
| 30 capsule, extended release in 1 bottle | 43975-323-03 | ANI Pharmaceuticals | 29 August 2019 |
| 90 capsule, extended release in 1 bottle | 43975-323-09 | ANI Pharmaceuticals | 29 August 2019 |
| 500 capsule, extended release in 1 bottle | 43975-323-50 | ANI Pharmaceuticals | 29 August 2019 |
| 500 capsule, extended release in 1 bottle | 70436-161-02 | Slate Run Pharmaceuticals | 12 April 2021 |
| 30 capsule, extended release in 1 bottle | 70436-161-04 | Slate Run Pharmaceuticals | 12 April 2021 |
| 90 capsule, extended release in 1 bottle | 70436-161-06 | Slate Run Pharmaceuticals | 12 April 2021 |
| 500 capsule, extended release in 1 bottle | 0093-7164-05 | Teva Pharmaceuticals | 20 March 2017 |
| 30 capsule, extended release in 1 bottle | 0093-7164-56 | Teva Pharmaceuticals | 20 March 2017 |
| 90 capsule, extended release in 1 bottle | 0093-7164-98 | Teva Pharmaceuticals | 20 March 2017 |
| 30 capsule, extended release in 1 bottle | 50090-3475-0 | A-S Medication Solutions | 9 October 2019 |
| 90 capsule, extended release in 1 bottle | 50090-3475-1 | A-S Medication Solutions | 14 June 2018 |
| 30 blister pack in 1 box, unit-dose / 1 capsule, extended release in 1 blister pack | 60687-330-21 | American Health Packaging | 14 August 2017 |
| 500 capsule, extended release in 1 bottle | 51407-740-05 | Golden State Medical Supply | 11 August 2023 |
| 30 capsule, extended release in 1 bottle | 51407-740-30 | Golden State Medical Supply | 11 August 2023 |
| 90 capsule, extended release in 1 bottle | 51407-740-90 | Golden State Medical Supply | 11 August 2023 |
| 30 blister pack in 1 carton / 1 capsule, extended release in 1 blister pack | 0904-7575-04 | Major Pharmaceuticals | 24 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 25 March 1998 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 TolterodineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Detrol prescribing information (Viatris Specialty) · U.S. National Library of Medicine, DailyMed
Need Tolterodine 4 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.