Quick answers
- What is Carbidopa and levodopa used for?
- The FDA-approved label (Sinemet, Organon LLC, August 1, 2026) says: “SINEMET is indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on SINEMET. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Carbidopa and levodopa have a boxed warning?
- No. None of the 64 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Carbidopa and levodopa?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Carbidopa and levodopa been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started January 13, 2017 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Carbidopa and levodopa?
- 37 companies list prescription products of Carbidopa and levodopa in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc., Amneal Pharmaceuticals LLC and A-S Medication Solutions.
What Carbidopa and levodopa is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SINEMET is indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on SINEMET. …
— FDA label: Sinemet, Organon LLC, effective August 1, 2026. Read the full label on DailyMed →
The FDA has 64 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 64 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| carbidopa 10 mg · levodopa 100 mg tablet | Generic | $0.0742 per tablet |
| carbidopa 10 mg · levodopa 100 mg tablet, orally disintegrating | Generic | $0.5981 per tablet |
| carbidopa 23.75 mg · levodopa 95 mg capsule, extended release | Generic | $3.18 per capsule |
| carbidopa 25 mg · levodopa 100 mg tablet | Generic | $0.0736 per tablet |
| carbidopa 25 mg · levodopa 100 mg tablet | Brand: Sinemet | $1.42 per tablet |
| carbidopa 25 mg · levodopa 100 mg tablet, extended release | Generic | $0.1103 per tablet |
| carbidopa 25 mg · levodopa 100 mg tablet, orally disintegrating | Generic | $0.6831 per tablet |
| carbidopa 25 mg · levodopa 250 mg tablet | Generic | $0.1250 per tablet |
| carbidopa 25 mg · levodopa 250 mg tablet, orally disintegrating | Generic | $0.8753 per tablet |
| carbidopa 36.25 mg · levodopa 145 mg capsule, extended release | Generic | $3.45 per capsule |
| carbidopa 48.75 mg · levodopa 195 mg capsule, extended release | Generic | $3.23 per capsule |
| carbidopa 50 mg · levodopa 200 mg tablet, extended release | Generic | $0.1780 per tablet |
| carbidopa 61.25 mg · levodopa 245 mg capsule, extended release | Generic | $3.95 per capsule |
| carbidopa hydrate 10 mg · levodopa 100 mg tablet | Generic | $0.0742 per tablet |
| carbidopa hydrate 23.75 mg · levodopa 95 mg capsule, extended release | Brand: Rytary | $3.98 per capsule |
| carbidopa hydrate 25 mg · levodopa 100 mg tablet | Generic | $0.0736 per tablet |
| carbidopa hydrate 25 mg · levodopa 100 mg tablet | Brand: Dhivy | $3.61 per tablet |
| carbidopa hydrate 25 mg · levodopa 100 mg tablet, extended release | Generic | $0.1103 per tablet |
| carbidopa hydrate 25 mg · levodopa 250 mg tablet | Generic | $0.1250 per tablet |
| carbidopa hydrate 35 mg · levodopa 140 mg capsule, extended release | Brand: Crexont | $4.59 per capsule |
| carbidopa hydrate 36.25 mg · levodopa 145 mg capsule, extended release | Brand: Rytary | $3.97 per capsule |
| carbidopa hydrate 48.75 mg · levodopa 195 mg capsule, extended release | Brand: Rytary | $3.98 per capsule |
| carbidopa hydrate 50 mg · levodopa 200 mg tablet, extended release | Generic | $0.1780 per tablet |
| carbidopa hydrate 52.5 mg · levodopa 210 mg capsule, extended release | Brand: Crexont | $4.58 per capsule |
| carbidopa hydrate 61.25 mg · levodopa 245 mg capsule, extended release | Brand: Rytary | $5.00 per capsule |
| carbidopa hydrate 70 mg · levodopa 280 mg capsule, extended release | Brand: Crexont | $4.58 per capsule |
| carbidopa hydrate 87.5 mg · levodopa 350 mg capsule, extended release | Brand: Crexont | $4.58 per capsule |
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.
- Sun Pharmaceutical Industries, Inc.8 products
- Amneal Pharmaceuticals LLC8 products
- A-S Medication Solutions7 products
- NCS HealthCare of KY, LLC dba Vangard Labs5 products
- Coupler LLC5 products
- Bryant Ranch Prepack5 products
- Remedyrepack Inc.5 products
- Advagen Pharma Ltd5 products
- ScieGen Pharmaceuticals, Inc.5 products
- Zydus Pharmaceuticals USA Inc.4 products
- Dr. Reddy's Laboratories Inc.3 products
- Rising Pharma Holdings, Inc.3 products
- American Health Packaging3 products
- Westminster Pharmaceuticals, LLC3 products
- Proficient Rx LP3 products
- Camber Pharmaceuticals, Inc.3 products
- TruPharma, LLC3 products
- Aurobindo Pharma Limited3 products
- Aphena Pharma Solutions - Tennessee, LLC3 products
- AvKARE3 products
- XLCare Pharmaceuticals, Inc.3 products
- Teva Pharmaceuticals USA, Inc.3 products
- Organon LLC2 products
- Accord Healthcare Inc.2 products
- Mylan Institutional Inc.2 products
- Alembic Pharmaceuticals Inc.2 products
- Mylan Pharmaceuticals Inc.2 products
- Alembic Pharmaceuticals Limited2 products
- Radha Pharmaceuticals, Inc.2 products
- Cardinal Health 107, LLC2 products
- Amneal Pharmaceuticals NY LLC2 products
- Major Pharmaceuticals2 products
- Safecor Health LLC2 products
- AvPAK1 product
- NuCare Pharmaceuticals, Inc.1 product
- AbbVie Inc.1 product
- Avion Pharmaceuticals, 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 |
|---|---|---|---|
| NDA017555 SINEMET | Organon | May 2, 1975 | 59, latest March 19, 2026 2026: Labeling · 2020: Manufacturing (CMC) · 2014: Labeling |
| NDA203312 RYTARY | Impax | January 7, 2015 | 7, latest March 19, 2026 2026: Labeling · 2019: Labeling · 2016: Labeling |
| NDA203952 DUOPA | Abbvie | January 9, 2015 | 7, latest March 19, 2026 2026: Labeling · 2020: Labeling · 2019: Labeling |
| NDA214869 DHIVY | Avion Pharms | November 12, 2021 | 3, latest March 19, 2026 2026: Labeling · 2022: Labeling · 2022: Labeling |
| NDA217186 CREXONT | Impax | August 7, 2024 | 2, latest May 15, 2026 2026: Labeling · 2026: Labeling |
Generic approvals (18)
- ANDA073589DR Reddys Labs SA · August 28, 1992
- ANDA073607DR Reddys Labs SA · August 28, 1992
- ANDA073618DR Reddys Labs SA · August 28, 1992
- ANDA074260Actavis Elizabeth · September 3, 1993
- ANDA075091Mylan · September 30, 1999
- ANDA076521Impax Labs · May 14, 2004
- ANDA077828Sun Pharm Inds · August 23, 2007
- ANDA078893Rising · September 18, 2008
- ANDA078536Sun Pharm Inds · October 28, 2008
- ANDA078690Sun Pharm · July 31, 2009
- ANDA202323Accord Hlthcare · February 8, 2013
- ANDA210341Alembic · June 5, 2019
- ANDA214092Sciegen Pharms · May 7, 2021
- ANDA214091Sciegen Pharms · October 5, 2021
- ANDA216505Rubicon Research · September 21, 2022
- ANDA216537Aurobindo Pharma Ltd · November 28, 2022
- ANDA217482Rubicon Research · June 4, 2024
- ANDA218939Ascent Pharms Inc · January 14, 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.
-
January 13, 2017 · Class II · Terminated · D-0495-2017
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., North Chicago, IL 60064 --- NDC 0074-3012-07 — AbbVie Inc.
-
January 12, 2017 · Class II · Terminated · D-0455-2017
Failed Dissolution Specifications
Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62756-519-88), b) 500-count bottles (NDC 62756-519-13) Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512 — Sun Pharmaceutical Industries, 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) | 197443, 197444, 197445, 308988, 308989, 476399, 476515, 483090, 724598, 724602 … (+10) |
|---|---|
| SPL set ID of the quoted label | 9b17b028-964a-473c-823d-81423535bd66 |
| FDA labels (SPL) | 64 |
| FDA applications | NDA017555, NDA203312, NDA203952, NDA214869, NDA217186, 18 ANDA |
| Active ingredients (FDA) | CARBIDOPA / LEVODOPA |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sinemet, Organon LLC, effective August 1, 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 →