Medicine
Solifenacin 5 mg tablet
Solifenacin 5 mg tablet is a generic prescription medicine for oral use, made by 18 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) with excursions permitted from 15°C to 30°C (59°F to 86°F).
Key facts
- Active ingredient (INN)
- Solifenacin
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 80 tablets, 30 tablets, 90 tablets and 62 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaAscend LaboratoriesIndiaCamber PharmaceuticalsIndiaGlenmark PharmaceuticalsIndiaNovadoz PharmaceuticalsIndiaUnichem LaboratoriesIndiaAjanta PharmaIndiaMacleods PharmaceuticalsIndiaBostal18 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 May 2019
- Identifiers
- RxCUI 477367, 477372DailyMed set ID c84682ca-afca-a066-e053-2995a90a3257, d6525817-bea1-4a4c-bed4-4873ee202cc8, c67107f4-348b-4a23-a67c-26fd8241ebd6 +23NDC 51407-471, 71205-559, 71205-561 +23Application ANDA211657, ANDA209333, ANDA210224 +11
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 18 labelers. The register lists 65 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 80 tablet, coated in 1 carton | 46708-192-08 | Alembic PharmaceuticalsIndia | 20 May 2019 |
| 30 tablet, coated in 1 bottle | 46708-192-30 | Alembic PharmaceuticalsIndia | 20 May 2019 |
| 90 tablet, coated in 1 bottle | 46708-192-90 | Alembic PharmaceuticalsIndia | 20 May 2019 |
| 1000 tablet, coated in 1 bottle | 46708-192-91 | Alembic PharmaceuticalsIndia | 20 May 2019 |
| 80 tablet, coated in 1 carton | 62332-192-08 | Alembic PharmaceuticalsIndia | 20 May 2019 |
| 30 tablet, coated in 1 bottle | 62332-192-30 | Alembic PharmaceuticalsIndia | 20 May 2019 |
| 90 tablet, coated in 1 bottle | 62332-192-90 | Alembic PharmaceuticalsIndia | 20 May 2019 |
| 1000 tablet, coated in 1 bottle | 62332-192-91 | Alembic PharmaceuticalsIndia | 20 May 2019 |
| 30 tablet, film coated in 1 bottle | 27241-037-03 | Ajanta PharmaIndia | 20 May 2019 |
| 90 tablet, film coated in 1 bottle | 27241-037-09 | Ajanta PharmaIndia | 20 May 2019 |
| 30 tablet, film coated in 1 bottle | 67877-527-30 | Ascend LaboratoriesIndia | 21 May 2019 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 67877-527-38 | Ascend LaboratoriesIndia | 21 May 2019 |
| 90 tablet, film coated in 1 bottle | 67877-527-90 | Ascend LaboratoriesIndia | 21 May 2019 |
| 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-878-03 | Aurobindo PharmaIndia | 27 December 2022 |
| 30 tablet, film coated in 1 bottle | 65862-878-30 | Aurobindo PharmaIndia | 27 December 2022 |
| 90 tablet, film coated in 1 bottle | 65862-878-90 | Aurobindo PharmaIndia | 27 December 2022 |
| 1000 tablet, film coated in 1 bottle | 65862-878-99 | Aurobindo PharmaIndia | 27 December 2022 |
| 30 tablet, film coated in 1 bottle | 31722-027-30 | Camber PharmaceuticalsIndia | 15 June 2022 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 31722-027-31 | Camber PharmaceuticalsIndia | 15 June 2022 |
| 90 tablet, film coated in 1 bottle | 31722-027-90 | Camber PharmaceuticalsIndia | 15 June 2022 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 68462-386-14 | Glenmark PharmaceuticalsIndia | 20 May 2019 |
| 30 tablet, film coated in 1 bottle | 68462-386-30 | Glenmark PharmaceuticalsIndia | 20 May 2019 |
| 90 tablet, film coated in 1 bottle | 68462-386-90 | Glenmark PharmaceuticalsIndia | 20 May 2019 |
| 30 tablet, coated in 1 container | 33342-148-07 | Macleods PharmaceuticalsIndia | 20 February 2024 |
| 90 tablet, coated in 1 container | 33342-148-10 | Macleods PharmaceuticalsIndia | 20 February 2024 |
| 30 tablet in 1 bottle | 72205-020-30 | Novadoz PharmaceuticalsIndia | 20 May 2019 |
| 90 tablet in 1 bottle | 72205-020-90 | Novadoz PharmaceuticalsIndia | 20 May 2019 |
| 1000 tablet in 1 bottle | 72205-020-99 | Novadoz PharmaceuticalsIndia | 20 May 2019 |
| 500 tablet, film coated in 1 bottle | 29300-328-05 | Unichem LaboratoriesIndia | 23 March 2020 |
| 30 tablet, film coated in 1 bottle | 29300-328-13 | Unichem LaboratoriesIndia | 23 March 2020 |
| 90 tablet, film coated in 1 bottle | 29300-328-19 | Unichem LaboratoriesIndia | 23 March 2020 |
| 90 tablet, film coated in 1 bottle | 0591-3795-19 | Actavis Pharma | 30 June 2020 |
| 30 tablet, film coated in 1 bottle | 0591-3795-30 | Actavis Pharma | 23 January 2023 |
| 30 tablet, film coated in 1 bottle | 60505-4702-3 | Apotex | 20 May 2019 |
| 256410 tablet, film coated in 1 box | 35561-285-00 | Bostal | 20 May 2019 |
| 30 tablet, film coated in 1 bottle | 35561-285-10 | Bostal | 20 May 2019 |
| 90 tablet, film coated in 1 bottle | 35561-285-11 | Bostal | 20 May 2019 |
| 500 tablet, film coated in 1 bottle | 35561-285-13 | Bostal | 20 May 2019 |
| 30 tablet, film coated in 1 bottle | 72303-0831-1 | HEC Pharm | 1 July 2026 |
| 90 tablet, film coated in 1 bottle | 72303-0831-2 | HEC Pharm | 1 July 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 19 November 2004 | 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 Solifenacin
Clinical summary
Solifenacin is a cholinergic muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. It is available as tablets and extended-release tablets for oral use. MedsAcross supplies Solifenacin 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 SolifenacinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- solifenacin succinate prescribing information (Macleods Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Solifenacin 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.