Medicine
Cyclosporine 0.5 mg/mL ophthalmic emulsion
Cyclosporine 0.5 mg/mL ophthalmic emulsion is a generic prescription medicine for ophthalmic use, made by 9 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 15°-25 °C (59°-77 °F).
Key facts
- Active ingredient (INN)
- Cyclosporine
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/mL
- Dosage form
- Ophthalmic emulsion
- Route
- Ophthalmic
- Packs
- 2 pouches, 1 pouch, 30 vials and 15 more
- Manufacturers
- CiplaIndiaLupinIndiaApotexDevatisKVK-TechMylan PharmaceuticalsSaptalis PharmaceuticalsTeva PharmaceuticalsUpsher-Smith Laboratories
- Origin register
- US FDA, United States
- Storage
- Store at 15°-25 °C (59°-77 °F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AD01 Cyclosporine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 February 2022
- Identifiers
- RxCUI 2572292DailyMed set ID 70c8a4a6-ebe2-457f-a626-400c338cec2d, da3fa070-b512-4568-871a-dc8d5a949d13, a7040dc6-063b-40ee-8f2a-153e87b08430 +6NDC 60505-6202, 0378-8760, 10702-808 +6Application NDA050790, ANDA205894, ANDA211943 +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 |
|---|---|---|---|
| 2 pouch in 1 carton / 30 vial, single-use in 1 pouch / .4 mL in 1 vial, single-use | 69097-292-03 | CiplaIndia | 21 September 2026 |
| 1 pouch in 1 carton / 30 vial, single-use in 1 pouch / .4 mL in 1 vial, single-use | 69097-292-97 | CiplaIndia | 21 September 2026 |
| 30 vial, single-use in 1 tray / .4 mL in 1 vial, single-use | 68180-214-30 | LupinIndia | 11 May 2022 |
| 60 vial, single-use in 1 tray / .4 mL in 1 vial, single-use | 68180-214-60 | LupinIndia | 11 May 2022 |
| 30 vial in 1 tray / .4 mL in 1 vial | 60505-6202-1 | Apotex | 7 February 2022 |
| 60 vial in 1 tray / .4 mL in 1 vial | 60505-6202-2 | Apotex | 7 February 2022 |
| 3 pouch in 1 carton / 10 vial, single-use in 1 pouch / .4 mL in 1 vial, single-use | 73043-005-01 | Devatis | 4 July 2024 |
| 6 pouch in 1 carton / 10 vial, single-use in 1 pouch / .4 mL in 1 vial, single-use | 73043-005-02 | Devatis | 4 July 2024 |
| 30 vial, single-use in 1 tray / .4 mL in 1 vial, single-use | 10702-808-03 | Kvk-Tech | 10 February 2022 |
| 60 vial, single-use in 1 tray / .4 mL in 1 vial, single-use | 10702-808-06 | Kvk-Tech | 10 February 2022 |
| 6 pouch in 1 carton / 5 vial, single-use in 1 pouch / .4 mL in 1 vial, single-use | 0378-8760-58 | Mylan Pharmaceuticals | 3 February 2022 |
| 12 pouch in 1 carton / 5 vial, single-use in 1 pouch / .4 mL in 1 vial, single-use | 0378-8760-91 | Mylan Pharmaceuticals | 3 February 2022 |
| 6 pouch in 1 carton / 5 vial, single-dose in 1 pouch / .4 mL in 1 vial, single-dose | 71656-012-30 | Saptalis Pharmaceuticals | 12 December 2025 |
| 12 pouch in 1 carton / 5 vial, single-dose in 1 pouch / .4 mL in 1 vial, single-dose | 71656-012-60 | Saptalis Pharmaceuticals | 12 December 2025 |
| 6 pouch in 1 carton / 5 vial, single-dose in 1 pouch / .4 mL in 1 vial, single-dose | 0480-4076-30 | Teva Pharmaceuticals | 28 October 2025 |
| 12 pouch in 1 carton / 5 vial, single-dose in 1 pouch / .4 mL in 1 vial, single-dose | 0480-4076-60 | Teva Pharmaceuticals | 28 October 2025 |
| 60 vial, single-use in 1 carton / .4 mL in 1 vial, single-use | 24979-126-18 | Upsher-Smith Laboratories | 27 March 2026 |
| 30 vial, single-use in 1 carton / .4 mL in 1 vial, single-use | 24979-126-19 | Upsher-Smith Laboratories | 27 March 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 Cyclosporine 0.5 mg/mL ophthalmic emulsion.
Other strengths and forms of Cyclosporine
Clinical summary
Cyclosporine is a calcineurin inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is available as capsules, ophthalmic emulsion and eye drops for oral and topical use. MedsAcross supplies Cyclosporine 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 CyclosporineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sandimmune prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Ikervis: European public assessment report (EPAR) · European Medicines Agency
- Verkazia: European public assessment report (EPAR) · European Medicines Agency
Need Cyclosporine 0.5 mg/mL ophthalmic emulsion 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.