Prescription medicine
Carbidopa and entacapone and levodopa First approved as Stalevo
Carbidopa and entacapone and levodopa (Stalevo) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $0.695 per carbidopa-levodopa-entacapone 25-100-200 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the carbidopa and entacapone and levodopa FDA label on DailyMed (effective March 19, 2026, Sandoz Inc); the NDA 21485 record on Drugs@FDA; every carbidopa and entacapone and levodopa label on DailyMed.
Highlights of the record
FDA label of March 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCarbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease.
Forms and strengths
- 12.5 mg / 50 mg / 200 mg
- 18.75 mg / 75 mg / 200 mg
- 25 mg / 100 mg / 200 mg
- 31.25 mg / 125 mg / 200 mg
- 37.5 mg / 150 mg / 200 mg
- 50 mg / 200 mg / 200 mg
Film-coated tablet.
On the market
- Earliest approval on file
- June 11, 2003 Stalevo 75, Orion Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first May 10, 2012; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 4 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.695 per tablet Carbidopa-levodopa-entacapone 25-100-200 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2025 0 Class I among all firms' recalls; latest October 7, 2025
- FAERS reports
- 484 through July 30, 2026
What is carbidopa and entacapone and levodopa used for?
From the label: indications and usageCarbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used:
To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products.
To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. […]
Conditions named in the indications of carbidopa and entacapone and levodopa's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Aromatic Amino Acid, Aromatic Amino Acid Decarboxylation Inhibitor and Catechol-O-Methyltransferase Inhibitor.
Source: FDA drug label (Carbidopa, Levodopa, and Entacapone), NDA021485 (Orion Pharma), as published by Sandoz Inc, effective March 19, 2026 (SPL set 9c16c0e0-3b97-486b-b7d5-579f5853e2c5), via openFDA; the full label on DailyMed
Is there a generic for carbidopa and entacapone and levodopa (Stalevo)?
The FDA approved the first generic carbidopa and entacapone and levodopa on May 10, 2012. 7 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists carbidopa and entacapone and levodopa from 4 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2003 earliest approval on file
- 2012 first generic approved
- 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 entacapone and levodopa (Stalevo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.695 per Carbidopa-levodopa-entacapone 25-100-200 mg tablet, about the same as a year earlier. 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-entacapone 12.5-50-200 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Carbidopa-levodopa-entacapone 12.5-50-200 mg tablet | Generic | $0.579 per tablet | $17.37 | -47% |
| Carbidopa-levodopa-entacapone 18.75-75-200 mg tablet | Generic | $0.628 per tablet | $18.84 | -9% |
| Carbidopa-levodopa-entacapone 25-100-200 mg tablet | Generic | $0.695 per tablet | $20.86 | +0.6% |
| Carbidopa-levodopa-entacapone 31.25-125-200 mg tablet | Generic | $0.641 per tablet | $19.23 | -12% |
| Carbidopa-levodopa-entacapone 37.5-150-200 mg tablet | Generic | $0.802 per tablet | $24.07 | +4% |
| Carbidopa-levodopa-entacapone 50-200-200 mg tablet | Generic | $0.757 per tablet | $22.71 | +5% |
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 entacapone and levodopa been recalled?
The FDA's Enforcement Report lists 1 recall naming carbidopa and entacapone and levodopa since 2025: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 7, 2025 | Class II | Rising Pharma Holding, Inc. | Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the carbidopa and entacapone and levodopa label say about other medicines?
The carbidopa and entacapone and levodopa label names 17 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ampicillin | drug interactions | These include probenecid, cholestyramine, and some antibiotics (e.g., erythromycin, rifampicin, ampicillin and chloramphenicol). |
| Apomorphine | drug interactions | Metabolized by Catechol-O-Methyltransferase (COMT) Drugs known to be metabolized by COMT, such as isoproterenol, epinephrine, norepinephrine, dopamine, dobutamine, alpha-methyldopa, apomorphine, isoetherine, and bitolterol should be administered with caution in patients receiving entacapone regardless of the route of … |
| Bromocriptine | warnings and precautions | 3 of these patients were also treated with pergolide and 1 with bromocriptine. |
| Chloramphenicol | drug interactions | These include probenecid, cholestyramine, and some antibiotics (e.g., erythromycin, rifampicin, ampicillin and chloramphenicol). |
| Cholestyramine | drug interactions | These include probenecid, cholestyramine, and some antibiotics (e.g., erythromycin, rifampicin, ampicillin and chloramphenicol). |
| Dobutamine | drug interactions | Metabolized by Catechol-O-Methyltransferase (COMT) Drugs known to be metabolized by COMT, such as isoproterenol, epinephrine, norepinephrine, dopamine, dobutamine, alpha-methyldopa, apomorphine, isoetherine, and bitolterol should be administered with caution in patients receiving entacapone regardless of the route of … |
| Epinephrine | drug interactions | Metabolized by Catechol-O-Methyltransferase (COMT) Drugs known to be metabolized by COMT, such as isoproterenol, epinephrine, norepinephrine, dopamine, dobutamine, alpha-methyldopa, apomorphine, isoetherine, and bitolterol should be administered with caution in patients receiving entacapone regardless of the route of … |
| Erythromycin | drug interactions | These include probenecid, cholestyramine, and some antibiotics (e.g., erythromycin, rifampicin, ampicillin and chloramphenicol). |
| Isoniazid | drug interactions | Dopamine D2 receptor antagonists, isoniazid, phenytoin, papaverine and iron salts: may reduce efficacy of carbidopa, levodopa and entacapone tablets |
| Isoproterenol | drug interactions | Metabolized by Catechol-O-Methyltransferase (COMT) Drugs known to be metabolized by COMT, such as isoproterenol, epinephrine, norepinephrine, dopamine, dobutamine, alpha-methyldopa, apomorphine, isoetherine, and bitolterol should be administered with caution in patients receiving entacapone regardless of the route of … |
| Metoclopramide | drug interactions | Dopamine D2 Receptor Antagonists Dopamine D2 receptor antagonists (e.g., metoclopramide, phenothiazines, butyrophenones, risperidone) may reduce the therapeutic effects of levodopa. |
| Phenelzine | contraindications | Taking nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine). |
| Phenytoin | drug interactions | Dopamine D2 receptor antagonists, isoniazid, phenytoin, papaverine and iron salts: may reduce efficacy of carbidopa, levodopa and entacapone tablets |
| Probenecid | drug interactions | These include probenecid, cholestyramine, and some antibiotics (e.g., erythromycin, rifampicin, ampicillin and chloramphenicol). |
Every other medicine the carbidopa and entacapone and levodopa label names
| Medicine named | Section | What the label says |
|---|---|---|
| Risperidone | drug interactions | Dopamine D2 Receptor Antagonists Dopamine D2 receptor antagonists (e.g., metoclopramide, phenothiazines, butyrophenones, risperidone) may reduce the therapeutic effects of levodopa. |
| Tranylcypromine | contraindications | Taking nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine and tranylcypromine). |
| Warfarin | drug interactions | Cases of increased INR in patients concomitantly using warfarin have been reported during the post-approval use of entacapone. |
Check carbidopa and entacapone and levodopa against other medicines
Source: FDA drug label (Carbidopa, Levodopa, and Entacapone), NDA021485 (Orion Pharma), as published by Sandoz Inc, effective March 19, 2026 (SPL set 9c16c0e0-3b97-486b-b7d5-579f5853e2c5), via openFDA; the full label on DailyMed
What do FAERS reports show for carbidopa and entacapone and levodopa?
The FDA Adverse Event Reporting System holds 484 reports that list carbidopa and entacapone and levodopa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 88 are coded as a death and 195 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.
The most reported reactions
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 entacapone and levodopa?
10 other medicines are given the same way (oral) and in the same FDA class as carbidopa and entacapone 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.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tolcapone | Parkinson's disease | 1 labeler | n/a | No current entry |
| Opicapone | Parkinson's disease | none listed | $24.67 per capsule 25 mg capsule | No current entry |
| Ropinirole | Parkinson's disease | 27 labelers | $0.046 per tablet 0.25 mg tablet | No current entry |
| Pramipexole | Parkinson's disease | 22 labelers | $0.0452 per tablet 0.25 mg tablet | No current entry |
| Benztropine | Parkinson's disease | 19 labelers | $0.0753 per tablet 1 mg tablet | A presentation being discontinued |
| Rasagiline | Parkinson's disease | 14 labelers | $0.521 per tablet 0.5 mg tablet | No current entry |
| Trihexyphenidyl | Parkinson's disease | 8 labelers | $0.0884 per tablet 2 mg tablet | No current entry |
| Selegiline | Parkinson's disease | 11 labelers | $0.756 per capsule 5 mg capsule | No current entry |
Every medicine labeled for the same conditions as carbidopa and entacapone 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 entacapone and levodopa
- 10 medicines for the same use
- Other aromatic amino acids
- the pharmacologic class, with prices and generics
- Carbidopa and entacapone and levodopa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other