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Opicapone

Opicapone is a COMT inhibitor taken along with levodopa/carbidopa to treat “off” episodes in people with Parkinson’s disease.

Brand name Ongentys
Drug class Catechol-o-methyltransferase Inhibitor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Opicapone at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Opicapone (Ongentys) is a once-daily add-on to levodopa/carbidopa for Parkinson’s disease “off” episodes, when symptoms return between doses. It blocks COMT, an enzyme that breaks down levodopa, which raises the amount of levodopa available, and it has been on the U.S. market since about 2019. Most people tolerate it well, and the usual changes are more dyskinesia (uncontrolled movements), dizziness on standing and constipation. Watch for sudden sleepiness, even dozing off while driving or talking, and report worsening movements, since your levodopa dose may need lowering. Families are often first to notice hallucinations or new urges to gamble, spend or eat, so ask them to speak up.

Clinical pearls

  • Take it at bedtime with no food for one hour before and at least one hour after the dose.
  • Tell hospital staff you take it, because drugs like epinephrine, dopamine and dobutamine can then trigger a fast heartbeat or blood pressure swings.
  • Older antidepressants called non-selective MAO inhibitors, like phenelzine, are off-limits, but selective MAO-B inhibitors for Parkinson’s can be combined.
  • Never stop it abruptly, because sudden withdrawal can cause fever, muscle stiffness and confusion, so plan any change with your prescriber.
How you get itPrescription only
Comes asCapsule
Earliest FDA record2019
Companies listing it with the FDA1
FDA label last updatedOct 15, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Opicapone, written from its FDA label.

What Opicapone is used for

▾

Opicapone is an add-on medicine for Parkinson’s disease.

  • Ongentys (oral capsule) is used with levodopa/carbidopa in people with Parkinson’s disease who have “off” episodes.

How Opicapone works

▾

Opicapone is a selective, reversible blocker of COMT, an enzyme that breaks down levodopa. When carbidopa stops the other main breakdown route, COMT becomes the main one. Blocking it lets more levodopa stay in the body.

Opicapone dosage

▾

Ongentys is taken by mouth once a day at bedtime.

  • Do not eat for 1 hour before or at least 1 hour after taking it.
  • If you miss a dose, skip it and take the next dose at the usual time the next day.
  • People with moderate liver impairment take a lower dose. Your prescriber will decide.
  • When stopping, your doctor may need to adjust your other Parkinson’s medicines.

Dosing details from the FDA-approved label

From the Opicapone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • General recommended dosage (Parkinson's disease patients, per label)
    • 50 mg administered orally once daily at bedtime
    • Patients should not eat food for 1 hour before and for at least 1 hour after intake of ONGENTYS
  • Moderate hepatic impairment (Child-Pugh B)
    • 25 mg orally once daily at bedtime
    • Avoid use in patients with severe (Child-Pugh C) hepatic impairment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION The recommended dosage is 50 mg administered orally once daily at bedtime. ( 2.1 ) Patients should not eat food for 1 hour before and for at least 1 hour after intake of ONGENTYS. ( 2.1 ) The recommended dosage in patients with moderate hepatic impairment is 25 mg orally once daily at bedtime; avoid use in patients with severe hepatic impairment. ( 2.2 ) 2.1 Dosing and Administration Information The recommended dosage of ONGENTYS is 50 mg administered orally once daily at bedtime. Patients should not eat food for 1 hour before and for at least 1 hour after intake of ONGENTYS [see Clinical Pharmacology ( 12.3 )]. 2.2 Dosage Recommendations for Patients with Hepatic Impairment In patients with moderate hepatic impairment (Child-Pugh B), the recommended dose of ONGENTYS is 25 mg orally once daily at bedtime [see Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )]. Avoid use of ONGENTYS in patients with severe (Child-Pugh C) hepatic impairment [ see Use in Specific Populations ( 8.7 ) , Clinical Pharmacology ( 12.3 ) ]. 2.3 D iscontinuation and Missed Dose When discontinuing ONGENTYS, monitor patients and consider adjustment of other dopaminergic therapies as needed. If a dose of ONGENTYS is missed, the next dose should be taken at the scheduled time the next day.

Read the full Dosage and Administration section on DailyMed →

Opicapone side effects

▾

The most common side effects seen in studies were:

Common side effects

  • Dyskinesia (uncontrolled movements)
  • Constipation
  • Increased blood creatine kinase (a muscle enzyme seen on blood tests)
  • Low blood pressure or fainting
  • Weight loss
  • Dizziness
  • Dry mouth
  • Trouble sleeping

When to get medical help

  • Call your doctor if you fall asleep during daily activities, such as driving, eating or talking, or feel suddenly drowsy.
  • Get help if you feel faint, pass out or get dizzy when standing.
  • Tell your doctor if your movements get worse or you have new uncontrolled movements.
  • Call your doctor if you see or hear things that aren’t there, or have delusions, agitation or aggressive behavior.
  • Tell your doctor about new intense urges to gamble, spend money, eat or have sex that you can’t control.
  • Get help for fever, muscle stiffness, confusion or unstable vital signs after stopping or lowering the dose.
  • Report a fast or irregular heartbeat or big blood pressure swings.

Call your doctor about sudden sleep episodes, hallucinations, new compulsive urges, fainting or worsening movements. Dyskinesia was the most common reason people stopped the medicine.

Opicapone warnings and precautions

▾
  • Sudden sleepiness: some people fall asleep during daily activities, including driving. If this happens and you continue the medicine, do not drive.
  • Low blood pressure and fainting: seen in 5% of Ongentys users versus 1% on placebo.
  • Dyskinesia: seen in 20% versus 6% on placebo. Lowering levodopa may help.
  • Hallucinations and psychosis: people with a major psychotic disorder should ordinarily not take it.
  • Impulse control problems: intense urges to gamble, spend, eat or have sex.
  • Withdrawal effects: fever, stiffness and confusion can occur after stopping or reducing dopamine-boosting medicines.
  • Heart effects: fast or irregular heartbeat and blood pressure swings with drugs broken down by COMT.

Opicapone interactions

▾

Some medicines can clash with opicapone.

  • Non-selective MAO inhibitors (phenelzine, isocarboxazid, tranylcypromine): must not be combined, due to risk of arrhythmias and blood pressure swings.
  • Drugs broken down by COMT (isoproterenol, epinephrine, norepinephrine, dopamine, dobutamine): may cause fast heartbeat, arrhythmias or blood pressure changes, including by inhalation.
  • Selective MAO-B inhibitors: can be used together.
  • Sedating medicines: may add to sleepiness.
  • Blood pressure–lowering medicines: may need adjusting if you feel faint.
  • Food: eating close to the dose lowers how much opicapone is absorbed.

Interactions listed in the FDA-approved label

From the Opicapone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Non-selective monoamine oxidase (MAO) inhibitors (e.g., phenelzine, isocarboxazid, and tranylcypromine): Both inhibit catecholamine metabolism, leading to increased levels of catecholamines; concomitant use may increase the risk of possible arrhythmias, increased heart rate, and excessive changes in blood pressure. Concomitant use is contraindicated.
  • Selective MAO-B inhibitors: Can be used concomitantly with ONGENTYS.
  • Drugs metabolized by catechol-O-methyltransferase (COMT): May affect the pharmacokinetics of those drugs, which may increase the risk of possible arrhythmias, increased heart rate, and excessive changes in blood pressure. Administer with caution; monitor for changes in heart rate, rhythm, and blood pressure.
Read the label’s full interactions text

7 DRUG INTERACTIONS 7.1 Non-Selective Monoamine Oxidase (MAO) Inhibitors Both ONGENTYS and non-selective MAO inhibitors (e.g., phenelzine, isocarboxazid, and tranylcypromine) inhibit catecholamine metabolism, leading to increased levels of catecholamines. Concomitant use may increase the risk of possible arrhythmias, increased heart rate, and excessive changes in blood pressure. Concomitant use of ONGENTYS with non-selective MAO inhibitors is contraindicated [see Contraindications ( 4 )] . Selective MAO-B inhibitors can be used concomitantly with ONGENTYS. 7.2 Effect of ONGENTYS on Other Drugs Drugs Metabolized by Catechol-O-Methyltransferase (COMT) Concomitant use of ONGENTYS with drugs metabolized by COMT may affect the pharmacokinetics of those drugs, which may increase the risk of possible arrhythmias, increased heart rate, and excessive changes in blood pressure [see Warnings and Precautions ( 5.1 )] . Drugs known to be metabolized by COMT should be administered with caution. Monitor for changes in heart rate, rhythm, and blood pressure in patients concomitantly treated with ONGENTYS and drugs metabolized by COMT [see Warnings and Precautions ( 5.1 )] .

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Opicapone

▾
  • Do not use with non-selective MAO inhibitors.
  • Do not use with a history of pheochromocytoma, paraganglioma or other catecholamine-secreting tumors.
  • Moderate liver impairment needs a lower dose. Avoid in severe liver impairment.
  • Avoid in end-stage kidney disease.
  • Pregnancy: animal data show possible fetal harm, and human data are lacking.
  • Breastfeeding: no human data. Discuss benefits and risks with your doctor.
  • Children: safety and effectiveness have not been established.
  • Older adults: no dose change is needed, though some may be more sensitive to side effects.
  • Tell your doctor about sleep disorders, psychosis or past compulsive urges.

Opicapone overdose

▾

No specific antidote is known. Treatment is mainly supportive care with close medical monitoring, and other medicines may be involved. If you take too much, call poison control at 1-800-222-1222 or visit www.poison.org.

What Opicapone does in the body

▾

Once-daily Ongentys reduced COMT activity in red blood cells by up to 84%, staying above 65% over 24 hours. Inhibition fades slowly after stopping, with over 35% still present 5 days after the last dose. It raised levodopa peak levels by 43–44% and overall exposure by 62–94%. At 16 times the recommended dose, it did not meaningfully affect the heart’s QT interval.

How your body processes Opicapone

▾

Opicapone reaches peak blood levels in about 2 hours. A meal lowers peak levels by 62% and overall exposure by 31%, and delays the peak by 4 hours. It is more than 99% bound to proteins in the blood, and its half-life is 1 to 2 hours. Sulphation is the main way the body processes it. Most of it leaves in the stool, with only a small amount in urine.

How to store Opicapone

▾

Store at a temperature below 30°C (86°F).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

58

Supplements & herbs that interact with Opicapone

58 supplements and herbal products have documented interactions with Opicapone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 2
  • Moderate · 39
  • Minor · 17
Every supplement checked against Opicapone — ranked by severity The full interaction hub: 2 major · 39 moderate · 17 minor · every one linked to its full report. Check Opicapone against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Opicapone: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Opicapone — the kind of thing our pharmacy team would talk through with you at the counter.

What is opicapone for?

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It’s an add-on to levodopa/carbidopa for Parkinson’s disease. It helps when your symptoms return between doses, called “off” episodes. It isn’t meant to be used alone.

How and when should I take it?

▾
Take your capsule by mouth once a day at bedtime. Don’t eat for 1 hour before or at least 1 hour after. If you miss a dose, just take the next one at the usual time the next day.

What side effects should I expect?

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Common ones include uncontrolled movements, constipation, dizziness, dry mouth, trouble sleeping and weight loss. Low blood pressure can also happen. Let your doctor know if movements get worse, since your levodopa dose may need adjusting.

Is there anything serious I should watch for?

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Yes. Tell your doctor right away if you fall asleep suddenly during the day, faint, see things that aren’t there, or have strong new urges like gambling or overspending. Fever, stiffness and confusion after stopping also need prompt attention.

Can I take it with my other medicines?

▾
Not with non-selective MAO inhibitors such as phenelzine or tranylcypromine. Be careful with drugs like epinephrine or dopamine, which can affect heart rate and blood pressure. Always check with me or your doctor before starting anything new.

Is it safe in pregnancy?

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There isn’t enough human data. Animal studies showed possible harm to the fetus. Talk with your doctor if you’re pregnant or planning to be.

Is Opicapone available over the counter?

▾
No. Opicapone is a prescription medicine: every Opicapone product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Opicapone first available?

▾
The earliest FDA record we hold for Opicapone is from 2019: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Opicapone was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Opicapone on HelloPharmacist

Detailed data & references for Opicapone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Opicapone forms and strengths (how it comes)

Opicapone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Opicapone inactive ingredients by manufacturer.

Capsule

By mouth
Brands Ongentys
How this form is used
What it may be used for
  • Ongentys is used with levodopa/carbidopa for “off” episodes in Parkinson’s disease.
Important instructions
  • Ongentys is taken by mouth once daily at bedtime.
  • Do not eat for 1 hour before or at least 1 hour after taking Ongentys.
  • If you miss a dose of Ongentys, take the next dose at the usual time the next day.
Available strengths 2 strengths
4 FDA-listed product records ⓘ

Opicapone on the U.S. market: products, makers and brands

How Opicapone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 2 Opicapone product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2019. Brand names on the directory include Ongentys; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
2
FDA-listed product records ⓘ
2019
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Opicapone is used (Medicaid data)

A general measure of how commonly Opicapone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Opicapone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

337
Medicaid prescriptions filled (Q1–Q4 2025)
$294,546 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Opicapone prescribed? Of the 1,601 medications we measure, Opicapone ranks #1,407 by Medicaid prescriptions — more than 12% of them.

Where Opicapone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Opicapone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 50 mg oral capsule is the most-dispensed Opicapone product — about 93% of these Medicaid prescriptions.

opicapone 50 MG Oral Capsule Most dispensed

312 Medicaid prescriptions (Q1–Q4 2025) 93% of Opicapone prescriptions shown $273,807 gross reimbursement (before rebates) ≈ $878 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2362180

opicapone 25 MG Oral Capsule

25 Medicaid prescriptions (Q1–Q4 2025) 7% of Opicapone prescriptions shown $20,739 gross reimbursement (before rebates) ≈ $830 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2362172

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Opicapone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 9 listed Opicapone NDCs with Medicaid activity.

Compare Opicapone products

A representative set of FDA-listed product records for Opicapone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Capsule
25 mg Oral Amneal Pharmaceuticals LLC NDA View NDC →
50 mg Oral Amneal Pharmaceuticals LLC NDA View NDC →

Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Opicapone NDCs →

Opicapone side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Opicapone — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Opicapone are hallucination, dyskinesia, fall; about 75% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

2,261
Reports mentioning it
75%
Reported as serious
12
Distinct effects shown
Most reported effects
Hallucination
314
Dyskinesia
306
Fall
258
On And Off Phenomenon
158
Tremor
143
Death
142
Gait Disturbance
131
Parkinson^s Disease
121
Confusional State
120
Constipation
105
Age groups
Elderly · 170Adult · 54

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Opicapone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Opicapone FDA approval history

How Opicapone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Opicapone was first approved by the FDA in 2019. It remains available in U.S. pharmacies today.

2019
First FDA approval
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Opicapone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Opicapone recalls since July 2021.

✅No Opicapone recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Opicapone RxCUI 2362167 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 2362171 In current FDA listings
    Clinical drug / strength (SCD) 25 MG RxCUI 2362172 50 MG RxCUI 2362180

Look up RxCUI 2362167 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Opicapone costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule · Oral 25 mg $24.67 per capsule NDC details & price history
Capsule · Oral 50 mg $24.76 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Opicapone brand names

Opicapone is sold under one brand name in the FDA directory — Ongentys. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Ongentys

Who makes Opicapone: manufacturers and labelers

One company lists Opicapone products with the FDA. By number of product records, the largest are Amneal Pharmaceuticals LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Amneal Pharmaceuticals LLC 2

Opicapone drug class (RxNorm)

Opicapone belongs to the Catechol-O-Methyltransferase Inhibitor class.

Pharmacologic class Catechol-O-Methyltransferase Inhibitor
Drug family (ATC) Other dopaminergic agents
How it works Catechol O-Methyltransferase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Opicapone page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 15, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Opicapone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Opicapone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
2
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Amneal Pharmaceuticals LLC
Linked label effective
Oct 15, 2025
Composite sections available
22
Linked SPL Set ID
a511a531-112e-43f8-a43f-5334b0efe979
Linked SPL Document ID
550f6797-b388-4ceb-885c-ef56f48ae06c
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Amneal Pharmaceuticals LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →