Quick answers
- What is Rasagiline used for?
- The FDA-approved label (Azilect, Teva Neuroscience, Inc., June 30, 2020) says: “AZILECT (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD). AZILECT, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinson’s disease” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Rasagiline have a boxed warning?
- No. None of the 16 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Rasagiline?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Rasagiline been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started December 28, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Rasagiline?
- 16 companies list prescription products of Rasagiline in the FDA NDC Directory, including Alvogen Inc., Florida Pharmaceutical Products, LLC and SKG Pharma Inc..
What Rasagiline is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AZILECT (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD). AZILECT, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinson’s disease
— FDA label: Azilect, Teva Neuroscience, Inc., effective June 30, 2020. Read the full label on DailyMed →
The FDA has 16 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.
The label quoted above has no boxed warning.
0 of 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 31 in the FDA NDC Directory |
| Brand names | Azilect |
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 |
|---|---|---|
| rasagiline mesylate 0.5 mg tablet | Generic | $0.4598 per tablet |
| rasagiline mesylate 0.5 mg tablet | Brand: Azilect | $44.05 per tablet |
| rasagiline mesylate 1 mg tablet | Generic | $0.9960 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 1, 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.
- Alvogen Inc.2 products
- Florida Pharmaceutical Products, LLC2 products
- SKG Pharma Inc.2 products
- Teva Pharmaceuticals USA, Inc.2 products
- Golden State Medical Supply, Inc.2 products
- Rising Pharma Holdings, Inc.2 products
- Torrent Pharmaceuticals Limited2 products
- Ascend Laboratories, LLC2 products
- NorthStar RxLLC2 products
- Chartwell RX, LLC2 products
- Remedyrepack Inc.2 products
- Carnegie Pharmaceuticals LLC2 products
- Macleods Pharmaceuticals Limited2 products
- Micro Labs Limited2 products
- Teva Neuroscience, Inc.2 products
- Bryant Ranch Prepack1 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 |
|---|---|---|---|
| NDA021641 AZILECT | Teva | May 16, 2006 | 13, latest June 16, 2020 2020: Labeling · 2018: Labeling · 2015: Manufacturing (CMC) |
Generic approvals (9)
- ANDA201970Orbion Pharms · March 15, 2016
- ANDA201889Alkem Labs Ltd · October 30, 2017
- ANDA201892Chartwell Rx · July 27, 2018
- ANDA207004Micro Labs · March 29, 2019
- ANDA206153Regcon Holdings · October 4, 2019
- ANDA201942Carnegie · November 18, 2021
- ANDA218163Rising · April 9, 2024
- ANDA208866Macleods Pharms · June 28, 2024
- ANDA210150Torrent · May 5, 2025
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.
-
December 28, 2022 · Class II · Terminated · D-0159-2023
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054 — 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) | 608328, 636664, 637185, 637218 |
|---|---|
| SPL set ID of the quoted label | a40d0e73-3f9f-4b01-979d-402c9cdaeb60 |
| FDA labels (SPL) | 16 |
| FDA applications | NDA021641, 9 ANDA |
| Active ingredients (FDA) | RASAGILINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Azilect, Teva Neuroscience, Inc., effective June 30, 2020; 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 →