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Primidone

Primidone is an anticonvulsant (seizure medicine) tablet used alone or with other seizure medicines to control grand mal, psychomotor, and focal epileptic seizures.

Brand name Mysoline
Drug class Anti-epileptic Agent
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 27 clinical label sets 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 6, 2026 🚨Recall on record · 4
Primidone 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

Primidone (Mysoline) is an older standby for grand mal, psychomotor and focal seizures, used alone or alongside other seizure medicines, that works both directly and through two active breakdown products, phenobarbital and PEMA; on the market since the 1950s, it is available as a generic. Drowsiness, dizziness and unsteadiness are what most people notice, mainly in the first weeks, and they often fade, which is why the dose starts low at bedtime and climbs slowly. Never stop it suddenly, since that can trigger status epilepticus (a long, dangerous seizure), and report any new low mood or thoughts of self-harm right away.

Clinical pearls

  • Do not take it if you have porphyria or a phenobarbital allergy, since primidone is partly converted into phenobarbital.
  • Your prescriber may check blood levels of primidone, and often phenobarbital too, to fine-tune the dose.
  • Rarely it lowers blood cells, so report fever, sore throat, easy bruising or paleness; one rare anemia responds to folic acid.
  • If you become pregnant, do not stop it on your own; vitamin K before delivery helps protect the newborn from bleeding.
How you get itPrescription only
Comes asTablet
Earliest FDA record1954
Companies listing it with the FDA22
FDA label last updatedSep 10, 2026
FDA’s strongest warning (boxed)None on the label

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

What Primidone is used for

▾

Primidone is a seizure medicine used for these epilepsy types:

  • Grand mal (generalized convulsive) seizures
  • Psychomotor seizures
  • Focal seizures
  • Grand mal seizures that haven't responded to other anticonvulsants (it may control them)

Mysoline tablets and Primidone tablets are both labeled for use alone or with other anticonvulsants.

How Primidone works

▾

The exact way primidone works against seizures isn't known. In animal studies it raised the seizure threshold or changed seizure patterns.

Primidone itself fights seizures. So do its two metabolites (breakdown products), phenobarbital and PEMA. PEMA also strengthens phenobarbital's effect in animals.

Primidone dosage

▾

Primidone tablets (Mysoline or generic Primidone) are taken by mouth. Treatment starts low and builds up over about 10 days to a maintenance amount taken in divided doses through the day.

  • Children under 8 follow a separate, lower schedule.
  • If you are switching from another seizure medicine, the old one is tapered slowly while primidone is increased.
  • Your doctor may check blood levels to adjust your dose.

Follow your prescriber's directions and your pharmacy label.

Dosing details from the FDA-approved label

From the Primidone 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.

  • Patients 8 years of age and older who have received no previous treatment
    • Days 1 to 3: 100 to 125 mg at bedtime
    • Days 4 to 6: 100 to 125 mg twice a day
    • Days 7 to 9: 100 to 125 mg three times a day
    • Day 10 to maintenance: 250 mg three times a day
    • Maximum: daily doses should not exceed 500 mg four times a day
    • Dosage should be individualized; serum primidone level of 5 to 12 mcg/mL is clinically effective
  • Most adults and children 8 years of age and over (usual maintenance)
    • Three to four 250 mg tablets in divided doses (250 mg three times a day or four times a day)
    • If required, an increase to five or six 250 mg tablets daily may be made
    • Maximum: 500 mg four times a day
    • Serum level determinations may be necessary for optimal dosage adjustment
  • Patients already receiving other anticonvulsants
    • Start at 100 to 125 mg at bedtime and gradually increase to maintenance level as the other drug is gradually decreased
    • Continue until satisfactory dosage level is achieved for the combination or the other medication is completely withdrawn
    • When primidone alone is the objective, transition should not be completed in less than 2 weeks
  • Children under 8 years of age
    • Days 1 to 3: 50 mg at bedtime
    • Days 4 to 6: 50 mg twice a day
    • Days 7 to 9: 100 mg twice a day
    • Day 10 to maintenance: 125 mg three times a day to 250 mg three times a day
    • Usual maintenance 125 to 250 mg three times daily or 10 to 25 mg/kg/day in divided doses
    • Pediatric regimen for children under 8 years of age
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Usual Dosage Patients 8 years of age and older who have received no previous treatment may be started on primidone tablets according to the following regimen using either 50 mg or scored 250 mg primidone tablets: Days 1 to 3: 100 to 125 mg at bedtime. Days 4 to 6: 100 to 125 mg twice a day. Days 7 to 9: 100 to 125 mg three times a day. Day 10 to maintenance: 250 mg three times a day. For most adults and children 8 years of age and over, the usual maintenance dosage is three to four 250 mg primidone tablets in divided doses (250 mg three times a day or four times a day). If required, an increase to five or six 250 mg tablets daily may be made, but daily doses should not exceed 500 mg four times a day. Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations of primidone may be necessary for optimal dosage adjustment. The clinically effective serum level for primidone is between 5 to 12 mcg/mL. INITIAL: ADULTS AND CHILDREN OVER 8 KEY: •=50 mg tablet; ●=250 mg tablet DAY 1 2 3 4 5 6 AM NOON PM •• •• •• •• •• •• •• •• •• DAY 7 8 9 10 11 12 AM NOON PM •• •• •• •• •• •• •• •• •• ● ● ● Adjust to Maintenance Patients Already Receiving Other Anticonvulsants Primidone tablets should be started at 100 to 125 mg at bedtime and gradually increased to maintenance level as the other drug is gradually decreased. This regimen should be continued until satisfactory dosage level is achieved for the combination, or the other medication is completely withdrawn. When therapy with primidone tablets alone is the objective, the transition from concomitant therapy should not be completed in less than 2 weeks. Pediatric Dosage For children under 8 years of age, the following regimen may be used: Days 1 to 3: 50 mg at bedtime. Days 4 to 6: 50 mg twice a day. Days 7 to 9: 100 mg twice a day. Day 10 to maintenance: 125 mg three times a day to 250 mg three times a day. For children under 8 years of age, the usual maintenance dosage is 125 to 250 mg three times daily or, 10 to 25 mg/kg/day in divided doses.

Read the full Dosage and Administration section on DailyMed →

Primidone side effects

▾

The most common early side effects are unsteadiness and dizziness. These often ease with continued use or a lower starting dose.

Common side effects

  • Unsteadiness or poor coordination (ataxia)
  • Dizziness or a spinning feeling (vertigo)
  • Nausea, vomiting, or loss of appetite
  • Tiredness or drowsiness
  • Double vision or involuntary eye movements
  • Irritability or emotional changes
  • Sexual impotency
  • Skin rash resembling measles
  • Double vision and nystagmus (involuntary eye movements)

When to get medical help

  • Call your doctor right away if you notice new or worsening depression, unusual mood or behavior changes, or thoughts of suicide or self-harm.
  • Never stop primidone suddenly. Abrupt withdrawal may trigger status epilepticus (a prolonged, dangerous seizure).
  • Tell your doctor about severe or persistent side effects. They may need to stop the medicine.
  • Rarely, primidone can lower certain blood cells (granulocytopenia, agranulocytosis, red-cell hypoplasia and aplasia). Report signs of blood problems promptly.
  • A rare type of anemia (megaloblastic anemia) can occur. It usually responds to folic acid without stopping primidone.

Rarely, blood cell problems occur. Persistent or severe side effects may mean the medicine needs to be stopped by your doctor.

Primidone warnings and precautions

▾
  • Don't stop suddenly. Abrupt withdrawal may cause status epilepticus (a prolonged, dangerous seizure).
  • Suicidal thoughts: Seizure medicines raise the risk of suicidal thoughts or behavior. Watch for new or worsening depression or unusual mood changes, and report them right away.
  • Pregnancy: Seizure medicines are linked to a higher rate of birth defects, though cause and effect isn't proven. Newborn bleeding problems have occurred, so vitamin K1 is advised.
  • It takes several weeks to judge how well a dose works.

Primidone interactions

▾

Be careful with these:

  • Other anticonvulsants: doses are adjusted carefully when combined or switched.
  • Phenobarbital: primidone is partly converted to it, so a phenobarbital allergy rules out primidone.

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 Primidone

▾
  • Do not use if you have porphyria.
  • Do not use if you are hypersensitive to phenobarbital.
  • Tell your doctor if you are pregnant, planning pregnancy, or nursing.
  • Consider the NAAED Pregnancy Registry if you are pregnant (1-888-233-2334).
  • Tell your doctor about any history of depression or mood changes.
  • Children under 8 use a different dosing schedule.

What Primidone does in the body

▾

In animal studies, primidone raised the threshold for seizures or altered seizure patterns. Primidone and its metabolites phenobarbital and PEMA each have anticonvulsant activity. The clinically effective blood level of primidone is between 5 and 12 mcg/mL.

How to store Primidone

▾

Store at 20° to 25°C (68° to 77°F) . Dispense in a tight, light-resistant container with a child-resistant closure.

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

124

Supplements & herbs that interact with Primidone

124 supplements and herbal products have documented interactions with Primidone 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 · 7
  • Moderate · 101
  • Minor · 16
Every supplement checked against Primidone — ranked by severity The full interaction hub: 7 major · 101 moderate · 16 minor · every one linked to its full report. Check Primidone 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.

3

Nutrient depletion considerations

Primidone has been associated with lower levels of 3 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Higher significance · 1
  • Moderate · 2
See the full Primidone nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Primidone: pharmacist answers to common questions

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

What is primidone for?

▾
Primidone helps control certain epileptic seizures: grand mal, psychomotor, and focal seizures. You can take it alone or with other seizure medicines. It may also help grand mal seizures that other medicines haven't controlled.

How do I take it?

▾
You swallow the tablets by mouth. Your doctor will usually start you on a small bedtime dose and increase it over about 10 days. After that you take it in divided doses through the day. Follow your label and prescriber exactly.

What side effects should I expect?

▾
Early on, many people feel dizzy or unsteady. This often fades with time or a lower starting dose. Nausea, tiredness, drowsiness, double vision, and irritability can also happen. Tell your doctor if side effects are severe or don't go away.

Can I stop it if I feel better?

▾
No. Stopping suddenly can trigger status epilepticus, a prolonged and dangerous seizure. If you want to stop or change your dose, talk to your doctor first so it can be done safely.

What should I watch for with my mood?

▾
Seizure medicines, including primidone, can raise the risk of suicidal thoughts or behavior. Watch for new or worsening depression, mood changes, or thoughts of self-harm. Call your doctor right away if you notice any of these.

Is it safe in pregnancy?

▾
Seizure medicines have been linked to a higher rate of birth defects, though most mothers on them have normal babies. Don't stop primidone on your own, because seizures can be dangerous too. Talk with your doctor about your plan, vitamin K1 near delivery, and the pregnancy registry.

Is Primidone available over the counter?

▾
No. Primidone is a prescription medicine: every Primidone 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 Primidone first available?

▾
The earliest FDA record we hold for Primidone is from 1954: 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 Primidone was first used.

Who makes Primidone?

▾
22 companies currently list Primidone products in the FDA's NDC Directory, including Advagen Pharma Limited, Aphena Pharma Solutions - Tennessee, LLC, American Health Packaging. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

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

More about Primidone on HelloPharmacist

Detailed data & references for Primidone 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.

Primidone forms and strengths (how it comes)

Primidone 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 Primidone inactive ingredients by manufacturer.

Tablet

By mouth
Brands Mysoline
How this form is used
What it may be used for
  • Mysoline tablets are used alone or with other anticonvulsants to control grand mal, psychomotor, and focal epileptic seizures.
  • Primidone tablets are used alone or with other anticonvulsants for the same seizure types.
Important instructions
  • Mysoline is started at a low bedtime dose and gradually increased over about 10 days.
  • Primidone tablets follow a similar gradual build-up, then divided doses through the day.
  • When switching from another seizure medicine to Mysoline or Primidone alone, the transition should take at least 2 weeks.
Available strengths 3 strengths
90 FDA-listed product records ⓘ

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

How Primidone 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.

22 companies list 42 Primidone product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1954. Brand names on the directory include Mysoline; the rest are generics.

1
Dose forms ⓘ
22
Labelers (makers, repackagers, distributors)
2
Brand names
42
FDA-listed product records ⓘ
1954
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Advagen Pharma Limited7%
Aphena Pharma Solutions - Tennessee, LLC7%
American Health Packaging5%
Amneal Pharmaceuticals LLC5%
Amneal Pharmaceuticals of New York LLC5%
AvKARE5%
Other makers67%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Primidone is used (Medicaid data)

A general measure of how commonly Primidone 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 Primidone 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.

102,071
Medicaid prescriptions filled (Q1–Q4 2025)
$1.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Primidone prescribed? Of the 1,601 medications we measure, Primidone ranks #509 by Medicaid prescriptions — more than 68% of them.

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

Utilization by Primidone 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 tablet is the most-dispensed Primidone product — about 84% of these Medicaid prescriptions.

primidone 50 MG Oral Tablet Most dispensed

86,158 Medicaid prescriptions (Q1–Q4 2025) 84% of Primidone prescriptions shown $1.5M gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 14 of 87 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198150

primidone 250 MG Oral Tablet

14,614 Medicaid prescriptions (Q1–Q4 2025) 14% of Primidone prescriptions shown $362,967 gross reimbursement (before rebates) ≈ $25 per prescription (gross)

Summed across the 9 of 53 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 96304

primidone 125 MG Oral Tablet

1,299 Medicaid prescriptions (Q1–Q4 2025) 1% of Primidone prescriptions shown $119,370 gross reimbursement (before rebates) ≈ $92 per prescription (gross)

Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 328176

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 Primidone, 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 24 of 147 listed Primidone NDCs with Medicaid activity.

Compare Primidone products

A representative set of FDA-listed product records for Primidone — 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.)

Showing 42 of 42 products — FDA National Drug Code Directory. See every product, package size and price: browse all 42 Primidone NDCs →

Primidone 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 4 Primidone recalls since July 2021, covering 6 product listings. All of them are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III Jun 3, 2026 · Amneal Pharmaceuticals, LLC
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
  • Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceutic… Lots: Lot AM251676, EXP 11/31/2028 FDA record D-0585-2026 →
Ongoing Class III May 1, 2026 · Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
  • Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose… Lots: Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027 FDA record D-0537-2026 →
  • Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose… Lots: Lot#: 1027583, Exp 09/30/2027 FDA record D-0536-2026 →
Ongoing Class III Apr 27, 2026 · Golden State Medical Supply Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
  • Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01 Lots: Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026 FDA record D-0535-2026 →
  • Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05 Lots: Lot#: GS066750, GS067084, GS067710, GS067873, Exp 3/31/2028; GS068339, GS068897, Exp 8/31/2028 FDA record D-0534-2026 →
Ongoing Class III Apr 24, 2026 · Lannett Company Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
  • Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01. Lots: Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028. FDA record D-0533-2026 →

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) Primidone RxCUI 8691 2 dose forms · 4 strengths
  1. Dose form (SCDF) Oral Suspension RxCUI 373593 No current FDA listing
    Clinical drug / strength (SCD) 50 MG/ML RxCUI 312627
  2. Dose form (SCDF) Oral Tablet RxCUI 369489 In current FDA listings
    Clinical drug / strength (SCD) 50 MG RxCUI 198150 125 MG RxCUI 328176 250 MG RxCUI 96304

Look up RxCUI 8691 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 Primidone 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
Tablet · Oral 50 mg $0.091 per tablet NDC details & price history
Tablet · Oral 250 mg $0.228–$0.300 per tablet NDC details & price history
Tablet · Oral 125 mg $1.38 per tablet NDC details & price history
Tablet 250 mg $0.228 per tablet 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.

Primidone brand names

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

Mysoline

Who makes Primidone: manufacturers and labelers

22 companies list Primidone products with the FDA. By number of product records, the largest are Advagen Pharma Limited, Aphena Pharma Solutions - Tennessee, LLC, American Health Packaging. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Advagen Pharma Limited 3 Aphena Pharma Solutions - Tennessee, LLC 3 American Health Packaging 2 Amneal Pharmaceuticals LLC 2 Amneal Pharmaceuticals of New York LLC 2 AvKARE 2 AvPAK 2 Bausch Health US, LLC 2 Bryant Ranch Prepack 2 Carnegie Pharmaceuticals LLC 2 Dr. Reddy's Laboratories Limited 2 Golden State Medical Supply, Inc 2 Lannett Company, Inc. 2 NCS HealthCare of KY, LLC dba Vangard Labs 2 NorthStar Rx LLC 2 Oxford Pharmaceuticals, LLC 2 PD-Rx Pharmaceuticals, Inc. 2 Proficient Rx LP 2 Actavis Pharma, Inc. 1 Chartwell RX, LLC 1 Direct Rx 1 TruPharma LLC. 1

Primidone drug class (RxNorm)

Primidone belongs to the Anti-epileptic Agent class.

Pharmacologic class Anti-epileptic Agent
Drug family (ATC) Barbiturates and derivatives

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 Primidone 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 Sep 10, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Primidone.
📈
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 Primidone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
27
Finished products in the current FDA directory
42
Companies listing them (makers, repackagers, distributors)
22
FDA labeler codes behind them ⓘ
23
Linked representative label ⓘ
Bausch Health US, LLC
Linked label effective
Sep 10, 2026
Composite sections available
12
Linked SPL Set ID
af593171-dabb-4ea3-b44c-89ed457b2c46
Linked SPL Document ID
8604870a-4144-4f14-8720-616b25257be6
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. Bausch Health US, 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 →