Quick answers
- What is Ropinirole used for?
- The FDA-approved label (Ropinirole, Remedyrepack Inc., September 4, 2026) says: “Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2) 1.1 Parkinson’s Disease Ropinirole tablets are indicated for the treatment of Parkinson’s disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ropinirole have a boxed warning?
- No. None of the 58 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ropinirole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ropinirole been recalled?
- FDA enforcement reports list 7 recalls of products of this medicine; the newest started February 7, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Ropinirole?
- 25 companies list prescription products of Ropinirole in the FDA NDC Directory, including Bryant Ranch Prepack, Solco Healthcare US, LLC and Alembic Pharmaceuticals Inc..
What Ropinirole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2) 1.1 Parkinson’s Disease Ropinirole tablets are indicated for the treatment of Parkinson’s disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
— FDA label: Ropinirole, Remedyrepack Inc., effective September 4, 2026. Read the full label on DailyMed →
The FDA has 58 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 58 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, film coated, extended release · Tablet, extended release |
|---|---|
| Route | Oral |
| Prescription products | 149 in the FDA NDC Directory |
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 |
|---|---|---|
| ropinirole 12 mg tablet, extended release | Generic | $1.63 per tablet |
| ropinirole 2 mg tablet, extended release | Generic | $0.4143 per tablet |
| ropinirole 4 mg tablet, extended release | Generic | $0.4249 per tablet |
| ropinirole 6 mg tablet, extended release | Generic | $1.35 per tablet |
| ropinirole 8 mg tablet, extended release | Generic | $0.8810 per tablet |
| ropinirole hydrochloride 0.25 mg tablet, film coated | Generic | $0.0444 per tablet |
| ropinirole hydrochloride 0.5 mg tablet, film coated | Generic | $0.0431 per tablet |
| ropinirole hydrochloride 1 mg tablet, film coated | Generic | $0.0461 per tablet |
| ropinirole hydrochloride 12 mg tablet, film coated, extended release | Generic | $1.63 per tablet |
| ropinirole hydrochloride 2 mg tablet, extended release | Generic | $0.4143 per tablet |
| ropinirole hydrochloride 2 mg tablet, film coated | Generic | $0.0631 per tablet |
| ropinirole hydrochloride 2 mg tablet, film coated, extended release | Generic | $0.4143 per tablet |
| ropinirole hydrochloride 3 mg tablet, film coated | Generic | $0.0793 per tablet |
| ropinirole hydrochloride 4 mg tablet, extended release | Generic | $0.4249 per tablet |
| ropinirole hydrochloride 4 mg tablet, film coated | Generic | $0.0815 per tablet |
| ropinirole hydrochloride 4 mg tablet, film coated, extended release | Generic | $0.4249 per tablet |
| ropinirole hydrochloride 5 mg tablet, film coated | Generic | $0.0824 per tablet |
| ropinirole hydrochloride 6 mg tablet, extended release | Generic | $1.35 per tablet |
| ropinirole hydrochloride 6 mg tablet, film coated, extended release | Generic | $1.35 per tablet |
| ropinirole hydrochloride 8 mg tablet, extended release | Generic | $0.8810 per tablet |
| ropinirole hydrochloride 8 mg tablet, film coated, extended release | Generic | $0.8810 per tablet |
NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 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.
- Bryant Ranch Prepack21 products
- Solco Healthcare US, LLC19 products
- Alembic Pharmaceuticals Inc.12 products
- Alembic Pharmaceuticals Limited12 products
- Marlex Pharmaceuticals, Inc.7 products
- Bionpharma Inc.7 products
- Accord Healthcare Inc.7 products
- Glenmark Pharmaceuticals Inc., USA7 products
- A-S Medication Solutions6 products
- AvKARE5 products
- Dr. Reddys Laboratories Limited5 products
- Actavis Pharma, Inc.5 products
- Elite Laboratories, Inc.5 products
- Direct_Rx4 products
- Remedyrepack Inc.4 products
- AvPAK4 products
- NCS HealthCare of KY, LLC dba Vangard Labs4 products
- Asclemed USA, Inc.4 products
- Major Pharmaceuticals2 products
- Coupler LLC2 products
- American Health Packaging2 products
- Cardinal Health 107, LLC2 products
- Northwind Health Company, LLC1 product
- Preferred Pharmaceuticals Inc.1 product
- Proficient Rx LP1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (11)
- ANDA078110Prinston Inc · May 5, 2008
- ANDA090135Glenmark Pharms Ltd · February 25, 2010
- ANDA090429Alembic Ltd · March 24, 2010
- ANDA079165Mlv · February 7, 2012
- ANDA090869Actavis Elizabeth · May 17, 2012
- ANDA201576DR Reddys Labs Ltd · June 6, 2012
- ANDA079229Orbion Pharms · November 28, 2012
- ANDA202786Alembic · April 22, 2013
- ANDA204022Accord Hlthcare · February 28, 2017
- ANDA204413Prinston Inc · May 11, 2022
- ANDA217862Elite Labs Inc · November 10, 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.
-
February 7, 2023 · Class II · Terminated · D-0430-2023
CGMP Deviations: recalling drug products following an FDA inspection.
rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-237-01, UPC — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0425-2023
CGMP Deviations: recalling drug products following an FDA inspection.
rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-232-01, — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0431-2023
CGMP Deviations: recalling drug products following an FDA inspection.
rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-238-01, UPC — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0429-2023
CGMP Deviations: recalling drug products following an FDA inspection.
rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-236-01, UPC — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0428-2023
CGMP Deviations: recalling drug products following an FDA inspection.
rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-235-01, UPC — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0427-2023
CGMP Deviations: recalling drug products following an FDA inspection.
rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-234-01, UPC — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0426-2023
CGMP Deviations: recalling drug products following an FDA inspection.
rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-233-01, U — Accord Healthcare, 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ropinirole, Remedyrepack Inc., effective September 4, 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 →