Quick answers
- What is Cyclosporine used for?
- The FDA-approved label (Sandimmune, Novartis Pharmaceuticals Corporation, July 10, 2026) says: “Sandimmune capsules and Sandimmune injection, in combination with adrenal corticosteroids, are indicated for the: Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Treatment of chronic rejection in patients previously treated with other immunosuppressive agents. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cyclosporine have a boxed warning?
- Yes. The FDA label for Sandimmune has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Cyclosporine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cyclosporine been recalled?
- FDA enforcement reports list 7 recalls of products of this medicine; the newest started September 7, 2023 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Cyclosporine?
- 23 companies list prescription products of Cyclosporine in the FDA NDC Directory, including Novartis Pharmaceuticals Corporation, Apotex Corp. and Teva Pharmaceuticals USA, Inc..
What Cyclosporine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Sandimmune capsules and Sandimmune injection, in combination with adrenal corticosteroids, are indicated for the: Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Treatment of chronic rejection in patients previously treated with other immunosuppressive agents. …
— FDA label: Sandimmune, Novartis Pharmaceuticals Corporation, effective July 10, 2026. Read the full label on DailyMed →
The FDA has 26 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
11 of 26 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, liquid filled · Emulsion · Capsule, gelatin coated · Solution/ drops · Solution · Capsule · Injection |
|---|---|
| Route | Oral · Ophthalmic · Topical · Intravenous |
| Prescription products | 49 in the FDA NDC Directory |
| Brand names | Sandimmune, Neoral, Cyclosporine Modified, Cyclosporine, Modfied, Verkazia, Restasis, Cequa, Gengraf, Restasis Multidose, Vevye |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| cyclosporine 0.0009 g/mL solution/ drops | Brand: Cequa | $10.39 per unit |
| cyclosporine 0.5 mg/mL emulsion | Generic | $0.9081–$1.11 per unit 16 packages, lowest to highest |
| cyclosporine 0.5 mg/mL emulsion | Brand: Restasis | $10.31–$10.31 per unit 2 packages, lowest to highest |
| cyclosporine 0.5 mg/mL emulsion | Brand: Restasis MultiDose | $112.38 per mL |
| cyclosporine 1 mg/mL solution/ drops | Brand: Vevye | $379.87 per mL |
| cyclosporine 100 mg capsule, gelatin coated | Generic | $7.40 per capsule |
| cyclosporine 100 mg capsule, liquid filled | Generic | $1.25 per capsule |
| cyclosporine 100 mg capsule, liquid filled | Brand: Neoral | $11.77 per capsule |
| cyclosporine 100 mg/mL solution | Generic | $2.02 per mL |
| cyclosporine 25 mg capsule | Brand: Gengraf | $1.87 per capsule |
| cyclosporine 25 mg capsule, gelatin coated | Generic | $2.51 per capsule |
| cyclosporine 25 mg capsule, liquid filled | Generic | $0.3309 per capsule |
| cyclosporine 25 mg capsule, liquid filled | Brand: Neoral | $2.95 per capsule |
| cyclosporine 50 mg capsule, liquid filled | Generic | $0.8152 per capsule |
NADAC list of November 4, 2026; these prices took effect between January 2, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Novartis Pharmaceuticals Corporation6 products
- Apotex Corp.6 products
- Teva Pharmaceuticals USA, Inc.4 products
- Aurobindo Pharma Limited3 products
- Strides Pharma Science Limited3 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.3 products
- Harrow Eye, LLC2 products
- Dr. Reddy's Laboratories Inc.2 products
- Allergan, Inc.2 products
- American Health Packaging2 products
- Qilu Pharmaceutical Co., Ltd.2 products
- Sun Pharmaceutical Industries, Inc.2 products
- AbbVie Inc.2 products
- Cipla USA Inc.1 product
- Saptalis Pharmaceuticals, LLC.1 product
- Teva Pharmaceuticals, Inc.1 product
- Santen Incorporated1 product
- Upsher-Smith Laboratories, LLC1 product
- A-S Medication Solutions1 product
- Lupin Pharmaceuticals, Inc.1 product
- KVK-Tech, Inc.1 product
- Mylan Pharmaceuticals Inc.1 product
- Devatis, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA050573 SANDIMMUNE | Novartis | November 14, 1983 | 35, latest March 6, 2026 2026: Labeling · 2023: Labeling · 2015: Manufacturing (CMC) |
| NDA050625 SANDIMMUNE | Novartis | March 2, 1990 | 41, latest March 6, 2026 2026: Labeling · 2023: Labeling · 2022: Manufacturing (CMC) |
| NDA050715 NEORAL | Novartis | July 14, 1995 | 22, latest September 26, 2023 2023: Labeling · 2015: Labeling · 2013: Labeling |
| NDA050716 NEORAL | Novartis | July 14, 1995 | 27, latest September 26, 2023 2023: Labeling · 2015: Labeling · 2013: Manufacturing (CMC) |
| NDA050790 RESTASIS, RESTASIS MULTIDOSE | Abbvie | December 23, 2002 | 14, latest August 21, 2025 2025: Labeling · 2017: Labeling · 2016: Manufacturing (CMC) |
| NDA210913 CEQUA | Sun Pharm | August 14, 2018 | 1, latest September 20, 2019 2019: Labeling |
| NDA214965 VERKAZIA | Harrow Eye | June 23, 2021 | — |
| NDA217469 VEVYE | Harrow Eye | May 30, 2023 | 2, latest September 18, 2025 2025: Labeling · 2024: Labeling |
Generic approvals (15)
- ANDA065003Abbvie · May 12, 2000
- ANDA065044DR Reddys Labs SA · December 20, 2000
- ANDA065040Apotex · May 9, 2002
- ANDA065078Ivax Sub Teva Pharms · March 25, 2005
- ANDA065110Ivax Sub Teva Pharms · March 29, 2005
- ANDA210721Apotex · July 10, 2019
- ANDA205894Mylan · February 2, 2022
- ANDA216046Onesource · August 2, 2022
- ANDA203880Teva Pharms USA Inc · December 14, 2023
- ANDA209811Deva Holding As · May 21, 2024
- ANDA211943Saptalis Pharms · July 5, 2024
- ANDA219049Qilu · September 15, 2025
- ANDA209064Twi Pharms · January 21, 2026
- ANDA219288Jiangsu Anbison · June 1, 2026
- ANDA219652Aurobindo Pharma Ltd · September 17, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 7, 2023 · Class III · Terminated · D-1172-2023
Subpotent: Out of Specification result observed for low assay
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-5 — SUN PHARMACEUTICAL INDUSTRIES INC
-
September 16, 2022 · Class II · Terminated · D-1543-2022
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15. — Novartis Pharmaceuticals Corporation
-
April 1, 2022 · Class III · Terminated · D-0770-2022
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex — SUN PHARMACEUTICAL INDUSTRIES INC
-
May 7, 2021 · Class III · Terminated · D-0391-2021
Subpotent and Presence of Particulates .
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France Distributed — SUN PHARMACEUTICAL INDUSTRIES INC
-
February 22, 2021 · Class III · Terminated · D-0289-2021
Subpotent
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-5 — SUN PHARMACEUTICAL INDUSTRIES INC
-
February 8, 2017 · Class II · Terminated · D-0490-2017
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25 — Amerisource Health Services
-
February 3, 2017 · Class II · Terminated · D-0475-2017
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0 — Apotex Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 197552, 197553, 205175, 212810, 212844, 241834, 328160, 351291, 402092, 835835 … (+10) |
|---|---|
| SPL set ID of the quoted label | 5e5926a7-1de0-4b54-a5c0-286b6200ff82 |
| FDA labels (SPL) | 26 |
| FDA applications | NDA050573, NDA050625, NDA050715, NDA050716, NDA050790, NDA210913, NDA214965, NDA217469, 15 ANDA |
| Active ingredients (FDA) | CYCLOSPORINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sandimmune, Novartis Pharmaceuticals Corporation, effective July 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →