Medicine
Fingolimod 0.5 mg capsule
Fingolimod 0.5 mg capsule 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
Fingolimod capsules should be stored at 20ºC to 25ºC (68ºF to 77ºF)…
Key facts
- Active ingredient (INN)
- Fingolimod
- Brand
- Sold under the generic name
- Strength
- 0.5 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 blister pack, 30 capsules, 100 capsules and 44 more
- Manufacturers
- Zydus LifesciencesIndiaAscend LaboratoriesIndiaAlembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaAurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaGlenmark PharmaceuticalsIndiaBioconIndiaNovadoz PharmaceuticalsIndiaAccord HealthcareIndia19 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Fingolimod capsules should be stored at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AE01 Fingolimod
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 September 2019
- Identifiers
- RxCUI 1012895DailyMed set ID 0f638feb-6986-41e4-8f9c-2e6b84a5bb44, 8fe14efd-8f61-40db-9069-bb17daf3261a, bd981e18-1766-4a2d-9a9b-965ec960aa06 +18NDC 67877-476, 68462-166, 72205-227 +18Application ANDA208004, ANDA207985, ANDA207993 +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 19 labelers. The register lists 47 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 blister pack in 1 carton / 10 capsule in 1 blister pack | 46708-228-10 | Alembic PharmaceuticalsIndia | 28 April 2026 |
| 30 capsule in 1 bottle | 46708-228-30 | Alembic PharmaceuticalsIndia | 28 April 2026 |
| 100 blister pack in 1 carton / 10 capsule in 1 blister pack | 62332-228-10 | Alembic PharmaceuticalsIndia | 28 April 2026 |
| 30 capsule in 1 bottle | 62332-228-30 | Alembic PharmaceuticalsIndia | 28 April 2026 |
| 100 capsule in 1 bottle | 68382-912-01 | Zydus LifesciencesIndia | 11 October 2022 |
| 30 capsule in 1 bottle | 68382-912-06 | Zydus LifesciencesIndia | 11 October 2022 |
| 90 capsule in 1 bottle | 68382-912-16 | Zydus LifesciencesIndia | 11 October 2022 |
| 1 blister pack in 1 carton / 7 capsule in 1 blister pack | 68382-912-69 | Zydus LifesciencesIndia | 11 October 2022 |
| 4 blister pack in 1 carton / 7 capsule in 1 blister pack | 68382-912-70 | Zydus LifesciencesIndia | 11 October 2022 |
| 100 capsule in 1 bottle | 70771-1603-1 | Zydus LifesciencesIndia | 11 October 2022 |
| 30 capsule in 1 bottle | 70771-1603-3 | Zydus LifesciencesIndia | 11 October 2022 |
| 1 blister pack in 1 carton / 7 capsule in 1 blister pack | 70771-1603-7 | Zydus LifesciencesIndia | 11 October 2022 |
| 4 blister pack in 1 carton / 7 capsule in 1 blister pack | 70771-1603-8 | Zydus LifesciencesIndia | 11 October 2022 |
| 90 capsule in 1 bottle | 70771-1603-9 | Zydus LifesciencesIndia | 11 October 2022 |
| 30 capsule in 1 bottle | 16729-342-10 | Accord HealthcareIndia | 18 October 2022 |
| 30 capsule in 1 bottle | 67877-476-30 | Ascend LaboratoriesIndia | 21 September 2022 |
| 7 blister pack in 1 carton / 7 capsule in 1 blister pack | 67877-476-32 | Ascend LaboratoriesIndia | 21 September 2022 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 67877-476-33 | Ascend LaboratoriesIndia | 21 September 2022 |
| 28 capsule in 1 bottle | 67877-476-56 | Ascend LaboratoriesIndia | 21 September 2022 |
| 28 blister pack in 1 carton / 14 capsule in 1 blister pack | 67877-476-58 | Ascend LaboratoriesIndia | 21 September 2022 |
| 1 blister pack in 1 carton / 7 capsule in 1 blister pack | 65862-952-07 | Aurobindo PharmaIndia | 28 February 2024 |
| 4 blister pack in 1 carton / 7 capsule in 1 blister pack | 65862-952-28 | Aurobindo PharmaIndia | 28 February 2024 |
| 30 capsule in 1 bottle | 65862-952-30 | Aurobindo PharmaIndia | 28 February 2024 |
| 30 capsule in 1 bottle | 70377-019-11 | BioconIndia | 28 March 2024 |
| 28 capsule in 1 carton | 70377-019-21 | BioconIndia | 28 March 2024 |
| 30 capsule in 1 bottle | 31722-889-30 | Camber PharmaceuticalsIndia | 27 September 2019 |
| 30 capsule in 1 bottle | 43598-285-30 | Dr. Reddy's LaboratoriesIndia | 11 October 2022 |
| 3 blister pack in 1 carton / 10 capsule in 1 blister pack | 43598-285-31 | Dr. Reddy's LaboratoriesIndia | 11 October 2022 |
| 1 blister pack in 1 carton / 7 capsule in 1 blister pack | 43598-285-70 | Dr. Reddy's LaboratoriesIndia | 11 October 2022 |
| 7 blister pack in 1 carton / 7 capsule in 1 blister pack | 68462-166-07 | Glenmark PharmaceuticalsIndia | 28 September 2022 |
| 28 carton in 1 carton / 14 blister pack in 1 carton / 14 capsule in 1 blister pack | 68462-166-15 | Glenmark PharmaceuticalsIndia | 28 September 2022 |
| 30 capsule in 1 bottle | 68462-166-30 | Glenmark PharmaceuticalsIndia | 28 September 2022 |
| 30 capsule in 1 bottle | 72205-227-30 | Novadoz PharmaceuticalsIndia | 27 August 2026 |
| 2 blister pack in 1 carton / 14 capsule in 1 blister pack | 72205-227-32 | Novadoz PharmaceuticalsIndia | 27 August 2026 |
| 1 blister pack in 1 carton / 7 capsule in 1 blister pack | 62756-064-59 | Sun Pharmaceutical IndustriesIndia | 25 October 2022 |
| 90 capsule in 1 bottle | 62756-064-81 | Sun Pharmaceutical IndustriesIndia | 25 October 2022 |
| 30 capsule in 1 bottle | 62756-064-83 | Sun Pharmaceutical IndustriesIndia | 25 October 2022 |
| 2 blister pack in 1 carton / 14 capsule in 1 blister pack | 62756-064-96 | Sun Pharmaceutical IndustriesIndia | 25 October 2022 |
| 30 capsule in 1 bottle | 60505-4332-3 | Apotex | 18 October 2022 |
| 30 capsule in 1 bottle | 82249-385-30 | CivicaScript | 1 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.
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
Alternatives
Other makers and brands of Fingolimod 0.5 mg capsule.
Other strengths and forms of Fingolimod
Clinical summary
Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, among other approved uses. MedsAcross supplies Fingolimod 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 FingolimodFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Gilenya prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Gilenya: European public assessment report (EPAR) · European Medicines Agency
- Fingolimod Accord: European public assessment report (EPAR) · European Medicines Agency
Need Fingolimod 0.5 mg 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.