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Prescription medicine

Carbidopa and levodopa Brand names: Rytary, Crexont, Sinemet, Duopa, Dhivy

Carbidopa and levodopa (Crexont) is a prescription medicine with an FDA approval on record since 1975. FDA's NDC Directory lists it from 33 generic labelers, and pharmacies paid $0.0759 per carbidopa-levodopa 25-100 tablet in the October 7, 2026 NADAC survey.

  • Generic listed

Check it at the source: the carbidopa and levodopa FDA label on DailyMed (effective August 1, 2026, Organon LLC); the NDA 17555 record on Drugs@FDA; every carbidopa and levodopa label on DailyMed.

Highlights of the record

FDA label of August 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage

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.

Forms and strengths

  • 10 mg / 100 mg
  • 20 mg/ml / 4.63 mg/ml
  • 23.75 mg / 95 mg
  • 25 mg / 100 mg
  • 25 mg / 250 mg
  • 35 mg / 140 mg
  • 36.25 mg / 145 mg
  • 48.75 mg / 195 mg
  • 50 mg / 200 mg
  • 52.5 mg / 210 mg
  • 61.25 mg / 245 mg
  • 70 mg / 280 mg

Tablet; extended-release tablet; extended-release capsule; orally disintegrating tablet; suspension.

On the market

Earliest approval on file
May 2, 1975 Sinemet, Organon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
29 first August 28, 1992; 18 with a marketed status in Drugs@FDA
Labelers listed (NDC)
38 of which 33 under generic applications, 4 under brand applications, repackagers included
Last listed patent
December 21, 2041 Crexont capsules; not a generic launch date

Supply and safety

Pharmacy cost (NADAC)
$0.0759 per tablet Carbidopa-levodopa 25-100 tablet
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
5 since 2013 0 Class I among all firms' recalls; latest February 23, 2023; 1 more by firms not listed as its makers
FAERS reports
49,777 through July 30, 2026

What is carbidopa and levodopa used for?

From the label: indications and usage

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 is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. […]

Conditions named in the indications of carbidopa and levodopa's FDA labels, with every medicine labeled for each:

From other carbidopa and levodopa labels

Parkinson's disease: INDICATIONS AND USAGE 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.

FDA pharmacologic class: Aromatic Amino Acid and Aromatic Amino Acid Decarboxylation Inhibitor.

Source: FDA drug label (SINEMET), Organon LLC, effective August 1, 2026 (SPL set 9b17b028-964a-473c-823d-81423535bd66), via openFDA; the full label on DailyMed

What does the patient leaflet for carbidopa and levodopa say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about DUOPA?

DUOPA can cause serious side effects, including: Stomach and intestine (gastrointestinal) problems and problems from the procedure you will need to have to receive DUOPA (gastrointestinal procedure-related problems). Some of these problems may require surgery and may lead to death. ○ a blockage of your stomach or intestines (bezoar) ○ stopping movement through intestines (ileus) ○ drainage, redness, swelling, pain, feeling of warmth around the small hole in your stomach wall (stoma) ○ bleeding from stomach ulcers or your intestines ○ inflammation of your pancreas (pancreatitis) ○ infection in your lungs (pneumonia) ○ air or gas in your abdominal cavity ○ skin infection around the intestinal tube, pocket of infection (abscess), infection in your blood (sepsis) or abdominal cavity may occur, after surgery ○ stomach pain, nausea or vomiting Tell your healthcare provider right away if you have any of the following symptoms of stomach and intestine problems and gastrointestinal procedure-related problems: ○ stomach (abdominal) pain ○ constipation that does not go away ○ nausea or vomiting ○ fever ○ blood in your stool or a dark tarry stool (melanotic stool) You will need to have a procedure to make a small hole (called a “stoma”) in your stomach wall to place a gastro-jejunostomy tube (called a PEG-J tube) in an area of your small intestine called the jejunum. DUOPA is delivered directly to your small intestine through this tube. Your healthcare provider will talk to you about the stoma procedure. Before the stoma procedure, tell your healthcare provider if you have ever had a surgery or problems with your stomach. Talk to your healthcare provider about what you need to do to care for your stoma. […]

From the patient leaflet: What should I avoid while using DUOPA?

Do not drive, operate machinery, or do other activities until you know how DUOPA affects you. Sleepiness and falling asleep suddenly caused by DUOPA can happen as late as 1 year after you start your treatment.

From the patient leaflet: How should I store DUOPA?

Store DUOPA in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC). Do not freeze. Use at room temperature. Take one DUOPA cassette out of the carton and out of the refrigerator 20 minutes prior to use. Use the product at room temperature or you may not get the right amount of medication. Protect the cassette from light and keep it in the carton before using. Use DUOPA before the expiration date printed on the cassette. Keep DUOPA and all medicines out of the reach of children.

Source: FDA drug label (Duopa), AbbVie Inc., effective March 19, 2026 (SPL set 7066d371-dc6a-0d6f-7bed-e5dd4ee912da), via openFDA; the full label on DailyMed

Is there a generic for carbidopa and levodopa (Crexont)?

The FDA approved the first generic carbidopa and levodopa on August 28, 1992. 29 generic applications are approved; 18 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

FDA's NDC Directory lists carbidopa and levodopa from 33 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists 30 patents for Crexont capsules, the last expiring on December 21, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 1975 earliest approval on file
  • 1992 first generic approved
  • 2041 last listed patent
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for carbidopa and levodopa (Crexont)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0759 per Carbidopa-levodopa 25-100 tablet, down 7% from $0.0818 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Carbidopa-levodopa 25-100 tablet (generic)
  • Sinemet 25-100 mg tablet (brand)
$1.42
$0.0617
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Carbidopa-levo 25-100 mg ODTGeneric$0.687 per unitn/a-16%
Carbidopa-levo ER 23.75-95 capsuleGeneric$3.15 per capsule many times the lowest per-tablet cost; NADAC records the price, not why$94.60n/a
Carbidopa-levo ER 25-100 tabletGeneric$0.110 per tablet$3.30-13%
Carbidopa-levo ER 36.25-145 capsuleGeneric$3.39 per capsule many times the lowest per-tablet cost; NADAC records the price, not why$101.82n/a
Carbidopa-levo ER 48.75-195 capsuleGeneric$3.19 per capsule many times the lowest per-tablet cost; NADAC records the price, not why$95.64n/a
Carbidopa-levo ER 50-200 tabletGeneric$0.180 per tablet$5.39-13%
Carbidopa-levo ER 61.25-245 capsuleGeneric$3.93 per capsule many times the lowest per-tablet cost; NADAC records the price, not why$117.84n/a
Carbidopa-levodopa 10-100 tabletGeneric$0.0683 per tablet$2.05-25%
Carbidopa-levodopa 25-100 tabletGeneric$0.0759 per tablet$2.28-7%
Carbidopa-levodopa 25-250 tabletGeneric$0.119 per tablet$3.57-7%
Crexont ER 35 mg-140 mg capsuleBrand$4.59 per capsule many times the lowest per-tablet cost; NADAC records the price, not why$137.70+6%
Crexont ER 52.5 mg-210 mg capsuleBrand$4.58 per capsule many times the lowest per-tablet cost; NADAC records the price, not why$137.47+5%
Crexont ER 70 mg-280 mg capsuleBrand$4.58 per capsule many times the lowest per-tablet cost; NADAC records the price, not why$137.40+5%
Crexont ER 87.5 mg-350 mg capsuleBrand$4.58 per capsule many times the lowest per-tablet cost; NADAC records the price, not why$137.48+6%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has carbidopa and levodopa been recalled?

The FDA's Enforcement Report lists 6 recalls naming carbidopa and levodopa since 2013: 0 Class I (the most serious), 6 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of carbidopa and levodopa and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

StartedClassCompanyReason
February 23, 2023Class IIThe Harvard Drug GroupPackaging defect: observed packaging defect, blister packaging inadequately sealed.
March 2, 2020Class IIMayne Pharma IncProduct Mix-Up: A foreign tablet was found in bottle.
January 13, 2017Class IIAbbVie Inc.Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle …
January 12, 2017Class IISun Pharmaceutical Industries, Inc.Failed Dissolution Specifications
June 5, 2014Class IITeva Pharmaceuticals USAFailed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
July 2, 2013Class IIAidapak Services, LLC not a listed makerLabeling: Label Mixup: CARBIDOPA/LEVODOPA, Tablet, 25 mg/250 mg may have potentially been mislabeled as the following drug: DIGOXIN, Tablet, 0.125 mg, NDC …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the carbidopa and levodopa label say about other medicines?

The carbidopa and levodopa label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name carbidopa and levodopa. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
BromocriptinewarningsDopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene, are often used in the treatment of NMS; however, their effectiveness has not been demonstrated in controlled studies.
DantrolenewarningsDopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene, are often used in the treatment of NMS; however, their effectiveness has not been demonstrated in controlled studies.
Isoniaziddrug interactionsDopamine D 2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone) and isoniazid may reduce the therapeutic effects of levodopa.
LinezolidcontraindicationsCONTRAINDICATIONS DHIVY is contraindicated in patients Currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine, linezolid, and tranylcypromine) or have recently (within 2 weeks) taken a nonselective MAO inhibitor.
Metoclopramidedrug interactionsAlthough metoclopramide may increase the bioavailability of levodopa by increasing gastric emptying, metoclopramide may also adversely affect disease control by its dopamine receptor antagonistic properties.
PhenelzinecontraindicationsCONTRAINDICATIONS DHIVY is contraindicated in patients Currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine, linezolid, and tranylcypromine) or have recently (within 2 weeks) taken a nonselective MAO inhibitor.
Phenytoindrug interactionsIn addition, the beneficial effects of levodopa in Parkinson's disease have been reported to be reversed by phenytoin and papaverine.
Rasagilinedrug interactionsDHIVY may be administered concomitantly with the manufacturer's recommended dose of selective MAO-B inhibitors (e.g., rasagiline or selegiline HCl).
Risperidonedrug interactionsDopamine D 2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone) and isoniazid may reduce the therapeutic effects of levodopa.
SelegilinecontraindicationsSINEMET may be administered concomitantly with the manufacturer's recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCl) (see PRECAUTIONS, Drug Interactions ).
Tetrabenazinedrug interactionsUse of SINEMET with dopamine-depleting agents (e.g., reserpine and tetrabenazine) or other drugs known to deplete monoamine stores is not recommended.
TranylcyprominecontraindicationsCONTRAINDICATIONS DHIVY is contraindicated in patients Currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine, linezolid, and tranylcypromine) or have recently (within 2 weeks) taken a nonselective MAO inhibitor.

Check carbidopa and levodopa against other medicines

Source: FDA drug label (SINEMET), Organon LLC, effective August 1, 2026 (SPL set 9b17b028-964a-473c-823d-81423535bd66), via openFDA; the full label on DailyMed

What do FAERS reports show for carbidopa and levodopa?

The FDA Adverse Event Reporting System holds 49,777 reports that list carbidopa and levodopa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,354 are coded as a death and 13,612 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Fall4,736
  • Drug Ineffective (a use or a product term, not a reaction)4,389
  • Hallucination (named in the label)4,306
  • Tremor (named in the label)3,427
  • Death (an outcome recorded in the report)3,193
  • Dyskinesia (named in the label)3,095
  • Dizziness (named in the label)2,673
  • Parkinson^S Disease2,659

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as carbidopa and levodopa?

11 other medicines are given the same way (oral) and in the same FDA class as carbidopa and levodopa or labeled mainly for the same use (parkinson's disease), the same class first. Parkinson's disease lists all 19 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
RopiniroleParkinson's disease27 labelers$0.046 per tablet 0.25 mg tabletNo current entry
PramipexoleParkinson's disease22 labelers$0.0452 per tablet 0.25 mg tabletNo current entry
BenztropineParkinson's disease19 labelers$0.0753 per tablet 1 mg tabletA presentation being discontinued
RasagilineParkinson's disease14 labelers$0.521 per tablet 0.5 mg tabletNo current entry
TrihexyphenidylParkinson's disease8 labelers$0.0884 per tablet 2 mg tabletNo current entry
EntacaponeParkinson's disease11 labelers$0.325 per tablet 200 mg tabletNo current entry
SelegilineParkinson's disease11 labelers$0.756 per capsule 5 mg capsuleNo current entry
BromocriptineParkinson's disease6 labelers$1.61 per tablet 2.5 mg tabletNo current entry

Every medicine labeled for the same conditions as carbidopa and levodopa

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to carbidopa and levodopa
11 medicines for the same use
Other aromatic amino acids
the pharmacologic class, with prices and generics
Carbidopa and levodopa side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other