Prescription medicine
Levodopa Brand names: Inbrija; first approved as Dopar
Levodopa (Inbrija) is a prescription medicine with an FDA approval on record since 1970. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the levodopa FDA label on DailyMed (effective July 20, 2026, Merz Pharmaceuticals, LLC); the NDA 16913 record on Drugs@FDA; every levodopa label on DailyMed.
Highlights of the record
FDA label of July 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINBRIJA is indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa.
Forms and strengths
- 42 mg
Capsule.
On the market
- Earliest approval on file
- June 4, 1970 Dopar, Shire; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 21, 2033 Inbrija powder; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2015 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 12,013 through July 30, 2026
What is levodopa used for?
From the label: indications and usageINBRIJA is indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa. INBRIJA is an aromatic amino acid indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa
Conditions named in the indications of levodopa's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Aromatic Amino Acid.
Source: FDA drug label (Inbrija), Merz Pharmaceuticals, LLC, effective July 20, 2026 (SPL set 077c0f39-a3a2-4b2b-a184-09131889dcfb), via openFDA; the full label on DailyMed
What does the patient leaflet for 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 should I avoid while using INBRIJA?Do not drive, operate machinery, or do other activities until you know how INBRIJA affects you. INBRIJA can cause sleepiness and falling asleep suddenly as late as 1 year after you start treatment.
From the patient leaflet: How should I store INBRIJA?Store the inhaler and capsules in a dry place at room temperature between 68°F to 77°F (20°C to 25°C). Keep capsules in their foil (blister) packages until just before you are ready to use them. Do not store capsules inside the inhaler for a future dose. Keep the inhaler and capsules dry. Throw out the inhaler after all capsules in the carton have been used. Use the new inhaler that comes with your prescription refill. Keep INBRIJA and all medicines out of the reach of children.
Source: FDA drug label (Inbrija), Merz Pharmaceuticals, LLC, effective July 20, 2026 (SPL set 077c0f39-a3a2-4b2b-a184-09131889dcfb), via openFDA; the full label on DailyMed
Is there a generic for levodopa (Inbrija)?
No generic levodopa is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Inbrija powder, the last expiring on October 21, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1970 earliest approval on file
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has levodopa been recalled?
The FDA's Enforcement Report lists 1 recall naming levodopa since 2015: 0 Class I (the most serious), 1 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 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.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 12, 2015 | Class II | Health Innovations Pharmacy, Inc not a listed maker | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the levodopa label say about other medicines?
The levodopa label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 39 other medicines name levodopa. 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 |
|---|---|---|
| Isoniazid | drug interactions | DRUG INTERACTIONS Monitor patients on MAO-B inhibitors for orthostatic hypotension ( 7.1 ) Dopamine D2 antagonists, isoniazid, and iron salts: |
| Metoclopramide | drug interactions | Antagonists and Isoniazid Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce the effectiveness of levodopa. Monitor patients for worsening Parkinson's symptoms. |
| Phenelzine | contraindications | CONTRAINDICATIONS INBRIJA is contraindicated in patients currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine) or who have recently (within 2 weeks) taken a nonselective MAO inhibitor. |
| Risperidone | drug interactions | Antagonists and Isoniazid Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce the effectiveness of levodopa. Monitor patients for worsening Parkinson's symptoms. |
| Tranylcypromine | contraindications | CONTRAINDICATIONS INBRIJA is contraindicated in patients currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine) or who have recently (within 2 weeks) taken a nonselective MAO inhibitor. |
Other labels that name levodopa
Source: FDA drug label (Inbrija), Merz Pharmaceuticals, LLC, effective July 20, 2026 (SPL set 077c0f39-a3a2-4b2b-a184-09131889dcfb), via openFDA; the full label on DailyMed
What do FAERS reports show for levodopa?
The FDA Adverse Event Reporting System holds 12,013 reports that list levodopa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,359 are coded as a death and 2,717 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 rose sharply in 2021 (2,286, against a median of 531 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other aromatic amino acids
- the pharmacologic class, with prices and generics
- Levodopa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other