Quick answers
- What is Fingolimod used for?
- The FDA-approved label (Gilenya, Novartis Pharmaceuticals Corporation, July 22, 2026) says: “GILENYA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fingolimod have a boxed warning?
- No. None of the 21 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fingolimod?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fingolimod been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started July 11, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Fingolimod?
- 22 companies list prescription products of Fingolimod in the FDA NDC Directory, including Novartis Pharmaceuticals Corporation, XLCare Pharmaceuticals, Inc. and Dr. Reddy's Laboratories Inc..
What Fingolimod is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
GILENYA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. …
— FDA label: Gilenya, Novartis Pharmaceuticals Corporation, effective July 22, 2026. Read the full label on DailyMed →
The FDA has 21 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 21 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 23 in the FDA NDC Directory |
| Brand names | Gilenya |
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 |
|---|---|---|
| fingolimod hydrochloride 0.5 mg capsule | Generic | $1.42 per capsule |
NADAC list of November 4, 2026; these prices took effect on 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 Corporation2 products
- XLCare Pharmaceuticals, Inc.1 product
- Dr. Reddy's Laboratories Inc.1 product
- Apotex Corp.1 product
- Ascend Laboratories, LLC1 product
- Alembic Pharmaceuticals Inc.1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- AvKARE1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Accord Healthcare Inc.1 product
- Novadoz Pharmaceuticals LLC1 product
- Zydus Lifesciences Limited1 product
- Quallent Pharmaceuticals Health LLC1 product
- Alembic Pharmaceuticals Limited1 product
- Teva Pharmaceuticals, Inc.1 product
- CivicaScript LLC1 product
- Aurobindo Pharma Limited1 product
- Biocon Pharma Inc.1 product
- Camber Pharmaceuticals, Inc.1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Rising Pharma Holdings, Inc.1 product
- Solco Healthcare US, LLC1 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 |
|---|---|---|---|
| NDA022527 GILENYA | Novartis | September 21, 2010 | 25, latest August 22, 2025 2025: Labeling · 2024: Labeling · 2023: Manufacturing (CMC) |
Generic approvals (14)
- ANDA207979Biocon Ltd · December 4, 2019
- ANDA208014Sun Pharm · December 4, 2019
- ANDA207933Hetero Labs Ltd V · May 18, 2020
- ANDA207985Glenmark Pharms Ltd · June 18, 2020
- ANDA208008Teva Pharms USA · July 2, 2020
- ANDA207994Zydus Pharms · October 14, 2020
- ANDA207991Accord Hlthcare · October 28, 2020
- ANDA207993Apotex · December 18, 2020
- ANDA208004Alkem Labs Ltd · December 30, 2020
- ANDA208000DR Reddys · March 5, 2021
- ANDA207939Hec Pharm Co Ltd · November 10, 2021
- ANDA208003Prinston Inc · September 7, 2022
- ANDA207983Aurobindo Pharma Ltd · February 28, 2024
- ANDA207974Alembic · April 24, 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.
-
July 11, 2023 · Class II · Ongoing · D-0925-2023
Failed Dissolution Specifications
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30. — Ascend Laboratories, LLC
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) | 1012895, 1012899, 2045491, 2045493 |
|---|---|
| SPL set ID of the quoted label | cc9e1c8c-0e2b-44e2-878b-27057f786be9 |
| FDA labels (SPL) | 21 |
| FDA applications | NDA022527, 14 ANDA |
| Active ingredients (FDA) | FINGOLIMOD |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Gilenya, Novartis Pharmaceuticals Corporation, effective July 22, 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 →