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brivaracetam 75 mg Tablet, Film Coated, 1,000-count — NDC 50228-0559-10 package photo
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brivaracetam 75 mg Tablet, Film Coated, 1,000-count — NDC 50228-559-10 (Billing 50228-0559-10)

by ScieGen Pharmaceuticals, Inc. · 1000 TABLET, FILM COATED in 1 BOTTLE

This is a package of 1,000 tablets of brivaracetam 75 mg Tablet, Film Coated from ScieGen Pharmaceuticals, Inc., marketed since Mar 2026 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 50228-0559-10
🏷️ FDA NDC (as labeled) 50228-559-10 billing pads the product segment with a zero
This package
Contains1,000-count Pack sizes3 compare ↓
Main listing for product 50228-559 · Also comes in: 30 tablets 50228-559-30 60 tablets 50228-559-60
Rx only Generic On market CV ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50228-559-10
Product NDC 50228-559
11-digit billing NDC 50228055910
RxCUI 1739761, 1739768, 1739772, 1739776, 1739780
UNII U863JGG2IA
UPC 0350228558105, 0350228560603, 0350228560306, 0350228558600 +10 more
Application # ANDA219952
SPL Set ID bdbb6756-654c-46f1-a85c-7d5d1a89685a
Mechanism of action Epoxide Hydrolase Inhibitors
DEA schedule CV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-27
Route ORAL
Dosage form TABLET, FILM COATED
Substance BRIVARACETAM
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1739761
Why two NDCs? The FDA registers this code as 50228-559-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 50228-0559-10. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other antiepileptics class.

Drug family (ATC) Other antiepileptics
How it works Epoxide Hydrolase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Brivaracetam is used to treat partial onset seizures (seizures that involve only one part of the brain). Brivaracetam is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Brivaracetam is used to control partial-onset seizures — the type that start in one specific area of the brain. It's approved for adults and children as young as 1 month old, and i...
  • It's best to avoid alcohol entirely while you're on brivaracetam. Studies show that combining the two significantly worsens coordination, alertness, balance, reaction time, and mem...
  • Is it okay to have a glass of wine or beer while taking this medication?
  • The most common ones are drowsiness, dizziness, fatigue, and nausea — these tend to be most noticeable early on. For day-to-day side effects like tiredness, give it a little time a...
📖 Read our full Brivaracetam guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 tablets 60 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50228-0559-10 You're viewing this Main listing 1000 TABLET, FILM COATED in 1 BOTTLE 2026-03-27 — Active
50228-0559-30 50228-559-30 30 TABLET, FILM COATED in 1 BOTTLE 2026-03-27 — Active
50228-0559-60 50228-559-60 60 TABLET, FILM COATED in 1 BOTTLE 2026-03-27 — Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 1000 tablet, film coated in 1 bottle.
How does this package differ from NDC 50228-0559-30?
Both are brivaracetam 75 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 1,000-count one, while NDC 50228-0559-30 is the 30 tablets package.
What NDC number is used to bill for this package of brivaracetam 75 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
brivaracetam 75 mg 72205-0270-60 Novadoz 60 tablets $0.266 AB Availability likely —
Brivaracetam 75 mg 60505-4726-06 Apotex 60 tablets $0.266 AB Availability likely —
brivaracetam 75 mg 73473-0907-60 SolarisPharmaCorporation 60 tablets $0.266 AB Availability likely —
Briviact 75 mg 50474-0670-66 UCB, 60 tablets $24.058 AB Availability likely —
brivaracetam 75 mg 70710-1587-04 Zydus 1 tablet — AB FDA listed —
brivaracetam 75 mg 70771-1757-04 Zydus 1 tablet — AB FDA listed —
brivaracetam 75 mg 73190-0076-60 AvKARE 60 tablets — AB FDA listed —
Brivaracetam 75 mg 84386-0071-60 Aurobindo 60 tablets — AB FDA listed —
brivaracetam 75 mgthis 50228-0559-10 ScieGen 1000 tablets — AB FDA listed —
Brivaracetam 75 mg 76282-0825-60 Exelan 60 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White / Gray
ShapeOval
Imprint560;SG
Size15 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerScieGen Pharmaceuticals, Inc.
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA219952 (ANDA)
Labeler code50228
First marketedMar 2026
DEA scheduleCV
Product typeHuman Prescription Drug
Portfolio102 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 41 words ▾

1 INDICATIONS AND USAGE Brivaracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Brivaracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Adults (16 Years and Older): The recommended starting dosage for monotherapy or adjunctive therapy is 50 mg twice daily (100 mg per day). Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day). ( 2.1 ) Pediatric Patients (1 Month to less than 16 Years): The recommended dosage is based on body weight and is administered orally twice daily ( 2.1 ) Hepatic Impairment: Dose adjustment is recommended for all stages of hepatic impairment.

( 2.5 )

2.1Dosage Information Monotherapy or Adjunctive Therapy The recommended dosage for patients 1 month of age and older is included in Table 1. In pediatric patients weighing less than 50 kg, the recommended dosing regimen is dependent upon body weight. When initiating treatment, gradual dose escalation is not required.

Dosage should be adjusted based on clinical response and tolerability. Table 1: Recommended Dosage for Patients 1 Month of Age and Older Age and Body Weight Initial Dosage Minimum and Maximum Maintenance Dosage Adults (16 years and older) 50 mg twice daily (100 mg per day) 25 mg to 100 mg twice daily (50 mg to 200 mg per day) Pediatric patients weighing 50 kg or more 25 mg to 50 mg twice daily (50 mg to 100 mg per day) 25 mg to 100 mg twice daily (50 mg to 200 mg per day) Pediatric patients weighing 20 kg to less than 50 kg 0.5 mg/kg to 1 mg/kg twice daily (1 mg/kg to 2 mg/kg per day) 0.5 mg/kg to 2 mg/kg twice daily (1 mg/kg to 4 mg/kg per day) Pediatric patients weighing 11 kg to less than 20 kg 0.5 mg/kg to 1.25 mg/kg twice daily (1 mg/kg to 2.5 mg/kg per day) 0.5 mg/kg to 2.5 mg/kg twice daily (1 mg/kg to 5 mg/kg per day) Pediatric patients weighing less than 11 kg 0.75 mg/kg to 1.5 mg/kg twice daily (1.5 mg/kg to 3 mg/kg per day) 0.75 mg/kg to 3 mg/kg twice daily (1.5 mg/kg to 6 mg/kg per day)

2.2Administration Instructions for Brivaracetam Tablets Brivaracetam can be initiated with oral administration. Brivaracetam tablets may be taken with or without food. Brivaracetam Tablets Brivaracetam tablets should be swallowed whole with liquid. Brivaracetam tablets should not be chewed or crushed.

2.4Discontinuation of Brivaracetam Avoid abrupt withdrawal from brivaracetam in order to minimize the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.6) and Clinical Studies (14) ].

2.5Patients with Hepatic Impairment The recommended dosage for patients with hepatic impairment is included in Table 2 [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ] . Table 2: Recommended Dosage for Patients with Hepatic Impairment Age and Body Weight Initial Dosage Maximum Maintenance Dosage Adults (16 years and older) 25 mg twice daily (50 mg per day) 75 mg twice daily (150 mg per day) Pediatric patients weighing 50 kg or more Pediatric patients weighing 20 kg to less than 50 kg 0.5 mg/kg twice daily (1 mg/kg per day) 1.5 mg/kg twice daily (3 mg/kg per day) Pediatric patients weighing 11 kg to less than 20 kg 0.5 mg/kg twice daily (1 mg/kg per day) 2 mg/kg twice daily (4 mg/kg per day) Pediatric patients weighing less than 11 kg 0.75 mg/kg twice daily (1.5 mg/kg per day) 2.25 mg/kg twice daily (4.5 mg/kg per day)

2.6Co-administration with Rifampin Increase the brivaracetam dosage in patients on concomitant rifampin by up to 100% (i.e., double the dosage) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ] .

💊 Dosage Forms and Strengths 126 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets 10 mg: white to off-white, round, film coated tablets debossed with "556" on one side and "SG" on the other side. 25 mg: white to off-white, oval, film coated tablets debossed with "557" on one side and "SG" on the other side. 50 mg: white to off-white, oval, film coated tablets debossed with "558" on one side and “SG" on the other side.

75 mg: white to off-white, oval, film coated tablets debossed with "559" on one side and “SG" on the other side. 100 mg: white to off-white, oval, film coated tablets debossed with "560" on one side and “SG" on the other side. Tablets: 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg ( 3 )

⛔ Contraindications 40 words ▾

4 CONTRAINDICATIONS Hypersensitivity to brivaracetam or any of the inactive ingredients in brivaracetam (bronchospasm and angioedema have occurred) [see Warnings and Precautions (5.4) ] . Hypersensitivity to brivaracetam or any of the inactive ingredients in Brivaracetam tablets. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Suicidal Behavior and Ideation : Monitor patients for suicidal behavior and ideation. ( 5.1 ) Neurological Adverse Reactions : Monitor for somnolence and fatigue, and advise patients not to drive or operate machinery until they have gained sufficient experience on brivaracetam. ( 5.2 ) Psychiatric Adverse Reactions : Behavioral reactions including psychotic symptoms, irritability, depression, aggressive behavior, and anxiety; monitor patients for symptoms.

( 5.3 ) Hypersensitivity: Bronchospasm and Angioedema : Advise patients to seek immediate medical care. Discontinue and do not restart brivaracetam tablets if hypersensitivity occurs. ( 5.4 ) Serious Dermatologic Reactions : Discontinue Brivaracetam tablets unless an alternative etiology is established ( 5.5 ) Withdrawal of Antiepileptic Drugs : Brivaracetam tablets should be gradually withdrawn.

( 5.6 )

5.1Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including brivaracetam, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo.

In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed.

The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 years to 100 years) in the clinical trials analyzed. Table 3 shows absolute and relative risk by indication for all evaluated AEDs.

Table 3: Risk of Suicidal Thoughts or Behaviors by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients with Events Per 1000 Patients Drug Patients with Events Per 1000 Patients Relative Risk: Incidence of Events in Drug Patients/ Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1000 Patients Epilepsy 1.0 3.4 3.5

2.4Psychiatric 5.7 8.5 1.5

2.9Other 1.0 1.8 1.9

0.9Total 2.4 4.3 1.8

1.9The relative risk for suicidal thoughts or behavior was higher in clinical trials in patients with epilepsy than in clinical trials in patients with psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing brivaracetam or any other AED must balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior.

Shou… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: Suicidal Behavior and Ideation [see Warnings and Precautions (5.1) ] Neurological Adverse Reactions [see Warnings and Precautions (5.2) ] Psychiatric Adverse Reactions [see Warnings and Precautions (5.3) ] Hypersensitivity: Bronchospasm and Angioedema [see Warnings and Precautions (5.4) ] Serious Dermatologic Reactions [see Warnings and Precautions (5.5) ] Withdrawal of Antiepileptic Drugs [see Warnings and Precautions (5.6) ] Adults: Most common adverse reactions (at least 5% for brivaracetam and at least 2% more frequently than placebo) are somnolence/sedation, dizziness, fatigue, and nausea/vomiting.

( 6.1 ) Pediatric Patients: Most common adverse reactions are similar to those seen in adult patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, ScieGen Pharmaceuticals Inc at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In all controlled and uncontrolled trials performed in adult epilepsy patients, brivaracetam tablets were administered as adjunctive therapy to 2437 patients. Of these patients, 1929 were treated for at least 6 months, 1500 for at least 12 months, 1056 for at least 24 months, and 758 for at least 36 months.

A total of 1558 patients (1099 patients treated with brivaracetam tablets and 459 patients treated with placebo) constituted the safety population in the pooled analysis of Phase 3 placebo-controlled studies in patients with partial-onset seizures (Studies 1, 2, and 3) [see Clinical Studies (14) ] . The adverse reactions presented in Table 4 are based on this safety population; the median length of treatment in these studies was 12 weeks. Of the patients in those studies, approximately 51% were male, 74% were Caucasian, and the mean age was 38 years.

In the Phase 3 controlled epilepsy studies, adverse events occurred in 68% of patients treated with brivaracetam tablets and 62% treated with placebo. The most common adverse reactions occurring at a frequency of at least 5% in patients treated with brivaracetam tablets doses of at least 50 mg/day and greater than placebo were somnolence and sedation (16%), dizziness (12%), fatigue (9%), and nausea and vomiting symptoms (5%). The discontinuation rates due to adverse events were 5%, 8%, and 7% for patients randomized to receive brivaracetam tablets at the recommended doses of 50 mg, 100 mg, and 200 mg/day, respectively, compared to 4% in patients randomized to receive placebo.

Table 4 lists adverse reactions for brivaracetam tablets that occurred at least 2% more frequently for brivaracetam tablets doses of at least 50 mg/day than placebo. Table 4: Adverse Reactions in Pooled Placebo-Controlled Adjunctive Therapy Studies in Adult Patients with Partial Onset Seizures (Brivaracetam tablets 50 mg/day, 100 mg/day, and 200 mg/day) Adverse Reactions Brivaracetam (N=803) % Placebo (N=459) % Gastrointestinal disorders Nausea/vomiting symptoms 5 3 Constipation 2 0 Nervous system disorders Somnolence and sedation 16 8 Dizziness 12 7 Fatigue 9 4 Cerebellar coordination and balance disturbances Cerebellar coordination and balance disturbances includes ataxia, balance disorder, coordination abnormal, and nystagmus.

3 1 Psychiatric disorders Irritability 3 1 There was no apparent dose-dependent increase in adverse reactions listed in Table 4 with the exception of somnolence and sedation. Pediatric Patients Safety of brivaracetam tablets was evaluated in two open-label, safety and pharmacokinetic trials in pediatric patients 2 months to less than 16 years of age. Across studies of pediatric patients with partial onset seizures, 186 patients received brivaracetam oral… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Rifampin: Because of decreased concentrations, increasing brivaracetam dosage in patients on concomitant rifampin is recommended. ( 2.6 , 7.1 ) Carbamazepine: Because of increased exposure to carbamazepine metabolite, if tolerability issues arise, consider reducing carbamazepine dosage in patients on concomitant brivaracetam. ( 7.2 ) Phenytoin: Because phenytoin concentrations can increase, phenytoin levels should be monitored in patients on concomitant brivaracetam.

( 7.3 ) Levetiracetam: Brivaracetam had no added therapeutic benefit when coadministered with levetiracetam. ( 7.4 )

7.1Rifampin Co-administration with rifampin decreases brivaracetam plasma concentrations likely because of CYP2C19 induction [see Clinical Pharmacology (12.3) ] . Prescribers should increase the brivaracetam tablets dose by up to 100% (i.e., double the dosage) in patients while receiving concomitant treatment with rifampin [see Dosage and Administration (2.6) ] .

7.2Carbamazepine Co-administration with carbamazepine may increase exposure to carbamazepine-epoxide, the active metabolite of carbamazepine. Though available data did not reveal any safety concerns, if tolerability issues arise when co-administered, carbamazepine dose reduction should be considered [see Clinical Pharmacology (12.3) ] .

7.3Phenytoin Because brivaracetam tablets can increase plasma concentrations of phenytoin, phenytoin levels should be monitored in patients when concomitant brivaracetam tablets is added to or discontinued from ongoing phenytoin therapy [see Clinical Pharmacology (12.3) ] .

7.4Levetiracetam Brivaracetam provided no added therapeutic benefit to levetiracetam when the two drugs were co-administered [see Clinical Studies (14) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )

8.1Pregnancy Risk Summary Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series are insufficient to identify a risk of major birth defects, miscarriage or other maternal or fetal outcomes associated with brivaracetam use during pregnancy. In animal studies, brivaracetam produced evidence of developmental toxicity (increased embryo fetal mortality and decreased fetal body weights in rabbits; decreased growth, delayed sexual maturation, and long-term neurobehavioral changes in rat offspring) at maternal plasma exposures greater than clinical exposures [see Data ] .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Animal Data Oral administration of brivaracetam (0, 150, 300, or 600 mg/kg/day) to pregnant rats during the period of organogenesis did not produce any significant maternal or embryofetal toxicity. The highest dose tested was associated with maternal plasma exposures (AUC) approximately 30 times exposures in humans at the maximum recommended dose (MRD) of 200 mg/day. Oral administration of brivaracetam (0, 30, 60, 120, or 240 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in embryofetal mortality and decreased fetal body weights at the highest dose tested, which was also maternally toxic.

The highest no-effect dose (120 mg/kg/day) was associated with maternal plasma exposures approximately 4 times human exposures at the MRD. When brivaracetam (0, 150, 300, or 600 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, decreased growth, delayed sexual maturation (female), and long-term neurobehavioral changes were observed in the offspring at the highest dose. The highest no-effect dose (300 mg/kg/day) was associated with maternal plasma exposures approximately 7 times human exposures at the MRD.

Brivaracetam was shown to readily cross the placenta in pregnant rats after a single oral (5 mg/kg) dose of 14 C-brivaracetam. From 1 hour post dose, radioactivity levels in fetuses, amniotic fluid, and placenta were similar to those measured in maternal blood.

8.2Lactation Risk Summary Data from published literature indicate that brivaracetam is present in human milk. There is insufficient information on the effects of brivaracetam on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for brivaracetam tablets and any potential adverse effects on the breastfed infant from brivaracetam tablets or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness of brivaracetam tablets have been established in pediatric patients 1 month to less than 16 years of age. Use of brivaracetam tablets in these age groups is supported by evidence from adequate and well-controlled studies of brivaracetam tablets in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in pediatric patients 2 months to less than 16 years of age [see Dosage and Administration (2.1) , Warnings and Precautions (5.3) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ] .

Safety and effectiveness in pediatric patients below the age of 1 month have not been established. Juvenile Animal Toxicity Data The potential adverse effects of brivaracetam on postnatal growth and development were investigated in juvenile rats and dogs. Oral administration (0, 150, 300, or 600 mg/kg/day) to rats during the neonatal and juven… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series are insufficient to identify a risk of major birth defects, miscarriage or other maternal or fetal outcomes associated with brivaracetam use during pregnancy. In animal studies, brivaracetam produced evidence of developmental toxicity (increased embryo fetal mortality and decreased fetal body weights in rabbits; decreased growth, delayed sexual maturation, and long-term neurobehavioral changes in rat offspring) at maternal plasma exposures greater than clinical exposures [see Data ] .

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Animal Data Oral administration of brivaracetam (0, 150, 300, or 600 mg/kg/day) to pregnant rats during the period of organogenesis did not produce any significant maternal or embryofetal toxicity. The highest dose tested was associated with maternal plasma exposures (AUC) approximately 30 times exposures in humans at the maximum recommended dose (MRD) of 200 mg/day. Oral administration of brivaracetam (0, 30, 60, 120, or 240 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in embryofetal mortality and decreased fetal body weights at the highest dose tested, which was also maternally toxic.

The highest no-effect dose (120 mg/kg/day) was associated with maternal plasma exposures approximately 4 times human exposures at the MRD. When brivaracetam (0, 150, 300, or 600 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, decreased growth, delayed sexual maturation (female), and long-term neurobehavioral changes were observed in the offspring at the highest dose. The highest no-effect dose (300 mg/kg/day) was associated with maternal plasma exposures approximately 7 times human exposures at the MRD.

Brivaracetam was shown to readily cross the placenta in pregnant rats after a single oral (5 mg/kg) dose of 14 C-brivaracetam. From 1 hour post dose, radioactivity levels in fetuses, amniotic fluid, and placenta were similar to those measured in maternal blood.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Safety and effectiveness of brivaracetam tablets have been established in pediatric patients 1 month to less than 16 years of age. Use of brivaracetam tablets in these age groups is supported by evidence from adequate and well-controlled studies of brivaracetam tablets in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in pediatric patients 2 months to less than 16 years of age [see Dosage and Administration (2.1) , Warnings and Precautions (5.3) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ] .

Safety and effectiveness in pediatric patients below the age of 1 month have not been established. Juvenile Animal Toxicity Data The potential adverse effects of brivaracetam on postnatal growth and development were investigated in juvenile rats and dogs. Oral administration (0, 150, 300, or 600 mg/kg/day) to rats during the neonatal and juvenile periods of development (approximately equivalent to neonatal through adolescent development in humans) resulted in increased mortality, decreased body weight gain, delayed male sexual maturation, and adverse neurobehavioral effects at the highest dose tested and decreased brain size and weight at all doses.

Therefore, a no-effect dose was not established; the lowest dose tested in juvenile rats was associated with plasma exposures (AUC) approximately 2 times those in children and adolescents at the recommended maintenance dose. In dogs, oral administration (0, 15, 30, or 100 mg/kg/day) throughout the neonatal and juvenile periods of development induced liver changes similar to those observed in adult animals at the highest dose but produced no adverse effects on growth, bone density or strength, neurological testing, or neuropathology evaluation.

The overall no-effect dose (30 mg/kg/day) and the no-effect dose for adverse effects on developmental parameters (100 mg/kg/day) were associated with plasma exposures approximately equal to and 4 times, respectively, those in children and adolescents at the recommended maintenance dose.

🧓 Geriatric Use 81 words ▾

8.5Geriatric Use There were insufficient numbers of patients 65 years of age and older in the double-blind, placebo-controlled epilepsy trials (n=38) to allow adequate assessment of the effectiveness of brivaracetam tablets in this population. In general, dose selection for an elderly patient should be judicious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3) ] .

🆘 Overdosage 171 words ▾

10 OVERDOSAGE There is limited clinical experience with brivaracetam tablets overdose in humans. Somnolence and dizziness were reported in a patient taking a single dose of 1400 mg (14 times the highest recommended single dose) of brivaracetam tablets. The following adverse reactions were reported with brivaracetam tablets overdose: vertigo, balance disorder, fatigue, nausea, diplopia, anxiety, and bradycardia.

In general, the adverse reactions associated with brivaracetam tablets overdose were consistent with the known adverse reactions. There is no specific antidote for overdose with brivaracetam tablets. In the event of overdose, standard medical practice for the management of any overdose should be used.

An adequate airway, oxygenation, and ventilation should be ensured; monitoring of cardiac rate and rhythm and vital signs is recommended. A certified poison control center should be contacted for updated information on the management of overdose with brivaracetam tablets. There are no data on the removal of brivaracetam using hemodialysis, but because less than 10% of brivaracetam is excreted in urine, hemodialysis is not expected to enhance brivaracetam tablets clearance.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism by which brivaracetam exerts its anticonvulsant activity is not known. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.

12.2Pharmacodynamics Interactions with Alcohol In a pharmacokinetic and pharmacodynamic interaction study in healthy subjects, co-administration of brivaracetam tablets (single dose 200 mg [2 times greater than the highest recommended single dose]) and ethanol (continuous intravenous infusion to achieve a blood alcohol concentration of 60 mg/100 mL during 5 hours) increased the effects of alcohol on psychomotor function, attention, and memory. Co-administration of brivaracetam tablets and ethanol caused a larger decrease from baseline in saccadic peak velocity, smooth pursuit, adaptive tracking performance, and Visual Analog Scale (VAS) alertness, and a larger increase from baseline in body sway and in saccadic reaction time compared with brivaracetam tablets alone or ethanol alone.

The immediate word recall scores were generally lower for brivaracetam tablets when co-administered with ethanol. Cardiac Electrophysiology At a dose 4 times the maximum recommended dose, brivaracetam tablets did not prolong the QT interval to a clinically relevant extent.

12.3Pharmacokinetics Brivaracetam tablets, oral solution, and injection can be used interchangeably. Brivaracetam exhibits linear and time-independent pharmacokinetics at the approved doses. The pharmacokinetics of brivaracetam are similar when used as monotherapy or as adjunctive therapy for the treatment of partialonset seizures.

Absorption Brivaracetam is highly permeable and is rapidly and almost completely absorbed after oral administration. Pharmacokinetics is dose-proportional from 10 to 600 mg (a range that extends beyond the minimum and maximum single-administration dose levels described in Dosage and Administration [see Dosage and Administration (2.1) ] ). The median T max for tablets taken without food is 1 hour (range 0.25 to 3 hours).

Co-administration with a high-fat meal slowed absorption, but the extent of absorption remained unchanged. Specifically, when a 50 mg tablet was administered with a high-fat meal, C max (maximum brivaracetam plasma concentration during a dose interval, an exposure metric) was decreased by 37% and T max was delayed by 3 hours, but AUC (area under the brivaracetam plasma concentration versus time curve, an exposure metric) was essentially unchanged (decreased by 5%). Distribution Brivaracetam is weakly bound to plasma proteins (≤20%).

The volume of distribution is

0.5L/kg, a value close to that of the total body water. Brivaracetam is rapidly and evenly distributed in most tissues. Elimination Metabolism Brivaracetam is primarily metabolized by hydrolysis of the amide moiety to form the corresponding carboxylic acid metabolite, and secondarily by hydroxylation on the propyl side chain to form the hydroxy metabolite.

The hydrolysis reaction is mediated by hepatic and extra-hepatic amidase. The hydroxylation pathway is mediated primarily by CYP2C19. In human subjects possessing genetic variations in CYP2C19, production of the hydroxy metabolite is decreased 2-fold or 10-fold, while the blood level of brivaracetam itself is increased by 22% or 42%, respectively, in individuals with one or both mutated alleles.

CYP2C19 poor metabolizers and patients using inhibitors of CYP2C19 may require dose reduction. An additional hydroxy acid metabolite is created by hydrolysis of the amide moiety on the hydroxy metabolite or hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9). None of the 3 metabolites are pharmacologically active.

Excretion Brivaracetam is eliminated primarily by metabolism and by excretion in the urine. More than 95% of the dose, including metabolites, is excreted in the urine within 72 hours after… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 40 words ▾

12.1Mechanism of Action The precise mechanism by which brivaracetam exerts its anticonvulsant activity is not known. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Brivaracetam Tablets 10 mg are white to off-white, round, film coated tablets debossed with “556" on one side and "SG" on the other side. They are supplied as follows: Bottles of 30 tablets NDC 50228-556-30 Bottles of 60 tablets NDC 50228-556-60 Bottles of 1,000 tablets NDC 50228-556-10 25 mg are white to off-white, oval, film coated tablets debossed with "557" on one side and "SG" on the other side. They are supplied as follows: Bottles of 30 tablets NDC 50228-557-30 Bottles of 60 tablets NDC 50228-557-60 Bottles of 1,000 tablets NDC 50228-557-10 50 mg are white to off-white, oval, film coated tablets debossed with "558" on one side and "SG" on the other side.

They are supplied as follows: Bottles of 30 tablets NDC 50228-558-30 Bottles of 60 tablets NDC 50228-558-60 Bottles of 1,000 tablets NDC 50228-558-10 75 mg are white to off-white, oval, film coated tablets debossed with "559" on one side and "SG" on the other side. They are supplied as follows: Bottles of 30 tablets NDC 50228-559-30 Bottles of 60 tablets NDC 50228-559-60 Bottles of 1,000 tablets NDC 50228-559-10 100 mg are white to off-white, oval, film coated tablets debossed with "560" on one side and "SG" on the other side.

They are supplied as follows: Bottles of 30 tablets NDC 50228-560-30 Bottles of 60 tablets NDC 50228-560-60 Bottles of 1,000 tablets NDC 50228-560-10

16.2Storage and Handling Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.

16.1How Supplied Brivaracetam Tablets 10 mg are white to off-white, round, film coated tablets debossed with “556" on one side and "SG" on the other side. They are supplied as follows: Bottles of 30 tablets NDC 50228-556-30 Bottles of 60 tablets NDC 50228-556-60 Bottles of 1,000 tablets NDC 50228-556-10 25 mg are white to off-white, oval, film coated tablets debossed with "557" on one side and "SG" on the other side. They are supplied as follows: Bottles of 30 tablets NDC 50228-557-30 Bottles of 60 tablets NDC 50228-557-60 Bottles of 1,000 tablets NDC 50228-557-10 50 mg are white to off-white, oval, film coated tablets debossed with "558" on one side and "SG" on the other side.

They are supplied as follows: Bottles of 30 tablets NDC 50228-558-30 Bottles of 60 tablets NDC 50228-558-60 Bottles of 1,000 tablets NDC 50228-558-10 75 mg are white to off-white, oval, film coated tablets debossed with "559" on one side and "SG" on the other side. They are supplied as follows: Bottles of 30 tablets NDC 50228-559-30 Bottles of 60 tablets NDC 50228-559-60 Bottles of 1,000 tablets NDC 50228-559-10 100 mg are white to off-white, oval, film coated tablets debossed with "560" on one side and "SG" on the other side.

They are supplied as follows: Bottles of 30 tablets NDC 50228-560-30 Bottles of 60 tablets NDC 50228-560-60 Bottles of 1,000 tablets NDC 50228-560-10

📦 Storage and Handling 22 words ▾

16.2Storage and Handling Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.

📋 Description 113 words ▾

11 DESCRIPTION The chemical name of brivaracetam is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1 H -pyrrol-1-yl] butanamide. Its molecular formula is C 11 H 20 N 2 O 2 and its molecular weight is 212.29. The chemical structure is: Brivaracetam is a white to off-white crystalline powder.

It is very soluble in water, ethanol, and methanol. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane.

Tablets Brivaracetam tablets are for oral administration and contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and film coating agent contains polyethylene glycol 3350, polyethylene glycol 8000, polyvinyl alcohol, talc, and titanium dioxide. chemical structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). The Medication Guide accompanies the product and can also be accessed on https://sciegenpharm.com/medication-guide/ or by calling 1-855-724-3436. Suicidal Behavior and Ideation Counsel patients, their caregivers, and/or families that antiepileptic drugs, including brivaracetam, may increase the risk of suicidal thoughts and behavior, and advise patients to be alert for the emergence or worsening of symptoms of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or thoughts about self-harm.

Advise patients, their caregivers, and/or families to report behaviors of concern immediately to a healthcare provider [see Warnings and Precautions (5.1) ] . Neurological Adverse Reactions Counsel patients that brivaracetam tablets cause somnolence, fatigue, dizziness, and gait disturbance. These adverse reactions, if observed, are more likely to occur early in treatment but can occur at any time.

Advise patients not to drive or operate machinery until they have gained sufficient experience on brivaracetam tablets to gauge whether it adversely affects their ability to drive or operate machinery [see Warnings and Precautions (5.2) ] . Psychiatric Adverse Reactions Advise patients that brivaracetam tablets cause changes in behavior (e.g., aggression, agitation, anger, anxiety, and irritability) and psychotic symptoms. Instruct patients to report these symptoms immediately to their healthcare provider [see Warnings and Precautions (5.3) ] .

Hypersensitivity: Bronchospasm and Angioedema Advise patients that symptoms of hypersensitivity including bronchospasm and angioedema can occur with brivaracetam. Instruct them to seek immediate medical care should they experience signs and symptoms of hypersensitivity [see Warnings and Precautions (5.4) ] . Serious Dermatologic Reactions Advise patients of the early signs and symptoms of serious dermatologic adverse reactions and to report any occurrence immediately to a healthcare provider [see Warnings and Precautions (5.5) ] .

Withdrawal of Antiepileptic Drugs Advise patients not to discontinue use of brivaracetam tablets without consulting with their healthcare provider. Brivaracetam tablets should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus [see Warnings and Precautions (5.6) ] . Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during brivaracetam tablets therapy.

Lactation Counsel patients that brivaracetam, the active ingredient in brivaracetam tablets, is present in breast milk. Instruct patients to discuss with their healthcare provider if they are breastfeeding or intend to breastfeed [see Use in Specific Populations (8.2) ] . Dosing Instructions Counsel patients that brivaracetam tablets may be taken with or without food.

Instruct patients that brivaracetam tablets should be swallowed whole with liquid and not chewed or crushed [see Dosage and Administration (2.2) ] . Rx only Manufactured by: ScieGen Pharmaceuticals Inc Hauppauge, NY 11788 USA Revised: 3/2026

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 3/2026 MEDICATION GUIDE Brivaracetam (briv'' a ra' se tam) tablets CV for oral use What is the most important information I should know about Brivaracetam tablets? Brivaracetam is a federally controlled substance (CV) because it can be abused or lead to dependence.

Keep brivaracetam tablets in a safe place to prevent misuse and abuse. Selling or giving away brivaracetam tablets may harm others and is against the law. Like other antiepileptic drugs, brivaracetam tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying new or worse depression feeling agitated or restless trouble sleeping (insomnia) acting aggressive, feeling angry, or being violent an extreme increase in activity and talking (mania) attempts to commit suicide new or worse anxiety panic attacks new or worse irritability acting on dangerous impulses other unusual changes in behavior or mood Suicidal thoughts or actions can be caused by things other than medicines.

If you have suicidal thoughts or actions, your healthcare provider may check for other causes. How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Do not stop brivaracetam tablets without first talking to a healthcare provider .

Stopping brivaracetam tablets suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus). What is brivaracetam tablets?

Brivaracetam tablets are prescription medicine used to treat partial-onset seizures in people 1 month of age and older. It is not known if brivaracetam tablets are safe and effective in children younger than 1 month of age. Who should not take brivaracetam tablets?

Do not take brivaracetam tablets if you are allergic to brivaracetam or any of the ingredients in brivaracetam tablets. See the end of this Medication Guide for a complete list of ingredients in brivaracetam tablets. What should I tell my healthcare provider before starting brivaracetam tablets?

Before taking brivaracetam tablets, tell your healthcare provider about all of your medical conditions, including if you: have or had depression, mood problems, or suicidal thoughts or behavior. have liver problems. have abused or been dependent on prescription medicines, street drugs, or alcohol. are pregnant or plan to become pregnant. It is not known if brivaracetam tablets will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking brivaracetam tablets.

You and your healthcare provider will have to decide if you should take brivaracetam tablets while you are pregnant. are breastfeeding or plan to breastfeed. Brivaracetam passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take brivaracetam tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Brivaracetam tablets may affect the way other medicines work, and other medicines may affect how brivaracetam tablets works. Do not start a new medicine without first talking with your healthcare provider.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. How should I take brivaracetam tablets?

Take brivaracetam tablets exactly as your healthcare provider tells you. Your healthcare provider will tell you how much brivaracetam tablets… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Brivaracetam tablets, oral solution, and injection can be used interchangeably. Brivaracetam exhibits linear and time-independent pharmacokinetics at the approved doses. The pharmacokinetics of brivaracetam are similar when used as monotherapy or as adjunctive therapy for the treatment of partialonset seizures.

Absorption Brivaracetam is highly permeable and is rapidly and almost completely absorbed after oral administration. Pharmacokinetics is dose-proportional from 10 to 600 mg (a range that extends beyond the minimum and maximum single-administration dose levels described in Dosage and Administration [see Dosage and Administration (2.1) ] ). The median T max for tablets taken without food is 1 hour (range 0.25 to 3 hours).

Co-administration with a high-fat meal slowed absorption, but the extent of absorption remained unchanged. Specifically, when a 50 mg tablet was administered with a high-fat meal, C max (maximum brivaracetam plasma concentration during a dose interval, an exposure metric) was decreased by 37% and T max was delayed by 3 hours, but AUC (area under the brivaracetam plasma concentration versus time curve, an exposure metric) was essentially unchanged (decreased by 5%). Distribution Brivaracetam is weakly bound to plasma proteins (≤20%).

The volume of distribution is

0.5L/kg, a value close to that of the total body water. Brivaracetam is rapidly and evenly distributed in most tissues. Elimination Metabolism Brivaracetam is primarily metabolized by hydrolysis of the amide moiety to form the corresponding carboxylic acid metabolite, and secondarily by hydroxylation on the propyl side chain to form the hydroxy metabolite.

The hydrolysis reaction is mediated by hepatic and extra-hepatic amidase. The hydroxylation pathway is mediated primarily by CYP2C19. In human subjects possessing genetic variations in CYP2C19, production of the hydroxy metabolite is decreased 2-fold or 10-fold, while the blood level of brivaracetam itself is increased by 22% or 42%, respectively, in individuals with one or both mutated alleles.

CYP2C19 poor metabolizers and patients using inhibitors of CYP2C19 may require dose reduction. An additional hydroxy acid metabolite is created by hydrolysis of the amide moiety on the hydroxy metabolite or hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9). None of the 3 metabolites are pharmacologically active.

Excretion Brivaracetam is eliminated primarily by metabolism and by excretion in the urine. More than 95% of the dose, including metabolites, is excreted in the urine within 72 hours after intake. Fecal excretion accounts for less than 1% of the dose.

Less than 10% of the dose is excreted unchanged in the urine. Thirty-four percent of the dose is excreted as the carboxylic acid metabolite in urine. The terminal plasma half-life (t 1/2 ) is approximately 9 hours.

Specific Populations Age Pediatric Patients (2 months to less than 16 years) : An open-label, single-arm, multicenter, pharmacokinetic study with a 3week evaluation period and fixed 3-step up-titration using brivaracetam oral solution was conducted in 99 pediatric patients 2 months to less than 16 years of age. In those patients, plasma concentrations were shown to be dose-proportional. The pediatric pharmacokinetic profile for brivaracetam was determined in a population pharmacokinetic analysis using sparse plasma concentration data obtained in three open-label studies in 255 adult and pediatric patients with epilepsy 2 months to 22 years of age that received intravenous, oral solution, or oral tablet formulations.

A weight-based dosing regimen is necessary to achieve brivaracetam exposures in pediatric patients 1 month to less than 16 years of age that are similar to those observed in adults treated at effective doses of brivaracetam [ see Dosage and Administration (2.2) ]. The estimated plasma clearance was

1.09 L/h,

1.81 L/h, and

3.11L/h for pediatric patients weighing… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 149 words ▾

12.2Pharmacodynamics Interactions with Alcohol In a pharmacokinetic and pharmacodynamic interaction study in healthy subjects, co-administration of brivaracetam tablets (single dose 200 mg [2 times greater than the highest recommended single dose]) and ethanol (continuous intravenous infusion to achieve a blood alcohol concentration of 60 mg/100 mL during 5 hours) increased the effects of alcohol on psychomotor function, attention, and memory. Co-administration of brivaracetam tablets and ethanol caused a larger decrease from baseline in saccadic peak velocity, smooth pursuit, adaptive tracking performance, and Visual Analog Scale (VAS) alertness, and a larger increase from baseline in body sway and in saccadic reaction time compared with brivaracetam tablets alone or ethanol alone.

The immediate word recall scores were generally lower for brivaracetam tablets when co-administered with ethanol. Cardiac Electrophysiology At a dose 4 times the maximum recommended dose, brivaracetam tablets did not prolong the QT interval to a clinically relevant extent.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The effectiveness of brivaracetam in partial-onset seizures with or without secondary generalization was established in 3 fixed dose, randomized, double-blind, placebo-controlled, multicenter studies (Studies 1, 2, and 3), which included 1,550 patients. Patients enrolled had partial-onset seizures that were not adequately controlled with 1 to 2 concomitant antiepileptic drugs (AEDs). In each of these studies, 72% to 86% of patients were taking 2 or more concomitant AEDs with or without vagal nerve stimulation.

The median baseline seizure frequency across the 3 studies was 9 seizures per 28 days. Patients had a mean duration of epilepsy of approximately 23 years. All trials had an 8-week baseline period, during which patients were required to have at least 8 partial-onset seizures.

The baseline period was followed by a 12-week treatment period. There was no titration period in these studies. Study 1 compared doses of brivaracetam 50 mg/day and 100 mg/day with placebo.

Study 2 compared a dose of brivaracetam 50 mg/day with placebo. Study 3 compared doses of brivaracetam 100 mg/day and 200 mg/day with placebo. Brivaracetam was administered in equally divided twice daily doses.

Upon termination of brivaracetam treatment, patients were down-titrated over a 1-, 2-, and 4-week duration for patients receiving 25, 50, and 100 mg twice daily brivaracetam, respectively. The primary efficacy outcome in Study 1 and Study 2 was the percent reduction in 7-day partial-onset seizure frequency over placebo, while the primary outcome for Study 3 was the percent reduction in 28-day partial-onset seizure frequency over placebo. The criteria for statistical significance for all 3 studies was p<0.05.

Table 6 presents the primary efficacy outcome of the percent change in seizure frequency over placebo, based upon each study’s protocol-defined 7- and 28-day seizure frequency efficacy outcome. Table 6: Percent Reduction in Partial-Onset Seizure Frequency over Placebo (Studies 1, 2, and 3) Percent Reduction Over Placebo (%) a Based upon 7-day seizure frequency b Based upon 28-day seizure frequency STUDY 1 a Placebo (n=100) ------- 50 mg/day (n=99) 9.5 100 mg/day (n=100)

17.0 STUDY 2 a Placebo (n=96) ------- 50 mg/day (n=101)

16.9 Statistically significant based on testing procedure with alpha =

0.05STUDY 3 b Placebo (n=259) ------- 100 mg/day (n=252) 25.2 200 mg/day (n= 249)

25.7Figure 1 presents the percentage of patients by category of reduction from baseline in partial-onset seizure frequency per 28 days for all pooled patients in the 3 pivotal studies. Patients in whom the seizure frequency increased are shown at left as “worse.” Patients with an improvement in percent reduction from baseline partial-onset seizure frequency are shown in the 4 right-most categories. Figure 1: Proportion of Patients by Category of Seizure Response for Brivaracetam and Placebo Across all Three Double-Blind Trials Treatment with Levetiracetam In Studies 1 and 2, which evaluated brivaracetam tablets dosages of 50 mg and 100 mg daily, approximately 20% of the patients were on concomitant levetiracetam.

Although the numbers of patients were limited, brivaracetam provided no added benefit when it was added to levetiracetam. Although patients on concomitant levetiracetam were excluded from Study 3, which evaluated 100 and 200 mg daily, approximately 54% of patients in this study had prior exposure to levetiracetam. Figure 1

🔒 Drug Abuse and Dependence 116 words ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Brivaracetam tablets contain brivaracetam and is listed as a Schedule V controlled substance.

9.2Abuse In a human abuse potential study, single doses of brivaracetam tablets at therapeutic and supratherapeutic doses were compared to alprazolam (C-IV) (1.5 mg and 3 mg). Brivaracetam at the recommended single dose (50 mg) caused fewer sedative and euphoric effects than alprazolam; however, brivaracetam at supratherapeutic single doses (200 mg and 1000 mg) was similar to alprazolam on other measures of abuse.

9.3Dependence There was no evidence of physical dependence potential or a withdrawal syndrome with brivaracetam in a pooled review of placebo-controlled adjunctive therapy studies [see Warnings and Precautions (5.6) ].

🔒 Controlled Substance 16 words ▾

9.1Controlled Substance Brivaracetam tablets contain brivaracetam and is listed as a Schedule V controlled substance.

🧪 Nonclinical Toxicology 216 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a carcinogenicity study in mice, oral administration of brivaracetam tablets (0, 400, 550, or 700 mg/kg/day) for 104 weeks increased the incidence of liver tumors (hepatocellular adenoma and carcinoma) in male mice at the two highest doses tested. At the dose (400 mg/kg) not associated with an increase in liver tumors, plasma exposures (AUC) were approximately equal to those in humans at the maximum recommended dose (MRD) of 200 mg/day. Oral administration (0, 150, 230, 450, or 700 mg/kg/day) to rats for 104 weeks resulted in an increased incidence of thymus tumors (benign thymoma) in female rats at the highest dose tested.

At the highest dose not associated with an increase in thymus tumors, plasma exposures were approximately 9 times those in humans at the MRD. Mutagenesis Brivaracetam was negative for genotoxicity in in vitro (Ames, mouse lymphoma, and CHO chromosomal aberration) and in vivo (rat bone marrow micronucleus) assays. Impairment of Fertility Oral administration of brivaracetam tablets (0, 100, 200, or 400 mg/kg/day) to male and female rats prior to and throughout mating and early gestation produced no adverse effects on fertility.

The highest dose tested was associated with plasma exposures approximately 6 (males) and 13 (females) times those in humans at the MRD.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 213 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a carcinogenicity study in mice, oral administration of brivaracetam tablets (0, 400, 550, or 700 mg/kg/day) for 104 weeks increased the incidence of liver tumors (hepatocellular adenoma and carcinoma) in male mice at the two highest doses tested. At the dose (400 mg/kg) not associated with an increase in liver tumors, plasma exposures (AUC) were approximately equal to those in humans at the maximum recommended dose (MRD) of 200 mg/day. Oral administration (0, 150, 230, 450, or 700 mg/kg/day) to rats for 104 weeks resulted in an increased incidence of thymus tumors (benign thymoma) in female rats at the highest dose tested.

At the highest dose not associated with an increase in thymus tumors, plasma exposures were approximately 9 times those in humans at the MRD. Mutagenesis Brivaracetam was negative for genotoxicity in in vitro (Ames, mouse lymphoma, and CHO chromosomal aberration) and in vivo (rat bone marrow micronucleus) assays. Impairment of Fertility Oral administration of brivaracetam tablets (0, 100, 200, or 400 mg/kg/day) to male and female rats prior to and throughout mating and early gestation produced no adverse effects on fertility.

The highest dose tested was associated with plasma exposures approximately 6 (males) and 13 (females) times those in humans at the MRD.

📄 Recent Major Changes 7 words ▾

Warnings and Precautions ( 5.5 ) 8/2025

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL NDC 50228-556-30 Brivaracetam Tablets CV 10 mg Dispense accompanying medication guide to each patient. 30 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 10 mg 30 tablets

PRINCIPAL DISPLAY PANEL NDC 50228-556-60 Brivaracetam Tablets CV 10 mg Dispense accompanying medication guide to each patient. 60 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 10 mg 60 tablets

PRINCIPAL DISPLAY PANEL NDC 50228-556-10 Brivaracetam Tablets CV 10 mg Dispense accompanying medication guide to each patient. 1,000 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 10 mg 1000 tablets

PRINCIPAL DISPLAY PANEL NDC 50228-557-30 Brivaracetam Tablets CV 25 mg Dispense accompanying medication guide to each patient. 30 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 25 mg 30 tablets

PRINCIPAL DISPLAY PANEL NDC 50228-557-60 Brivaracetam Tablets CV 25 mg Dispense accompanying medication guide to each patient. 60 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 25 mg 60 tablets

PRINCIPAL DISPLAY PANEL NDC 50228-557-10 Brivaracetam Tablets CV 25 mg Dispense accompanying medication guide to each patient. 1,000 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 25 mg 1000 tablets

PRINCIPAL DISPLAY PANEL NDC 50228-558-30 Brivaracetam Tablets CV 50 mg Dispense accompanying medication guide to each patient. 30 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 50 mg 30 tablets

PRINCIPAL DISPLAY PANEL NDC 50228-558-60 Brivaracetam Tablets CV 50 mg Dispense accompanying medication guide to each patient. 60 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 50 mg 60 tablets

PRINCIPAL DISPLAY PANEL NDC 50228-558-10 Brivaracetam Tablets CV 50 mg Dispense accompanying medication guide to each patient. 1,000 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 50 mg 1000 tablets

PRINCIPAL DISPLAY PANEL NDC 50228-559-30 Brivaracetam Tablets CV 75 mg Dispense accompanying medication guide to each patient. 30 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 75 mg 30 tablets

PRINCIPAL DISPLAY PANEL NDC 50228-559-60 Brivaracetam Tablets CV 75 mg Dispense accompanying medication guide to each patient. 60 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 75 mg 60 tablets

PRINCIPAL DISPLAY PANEL NDC 50228-559-10 Brivaracetam Tablets CV 75 mg Dispense accompanying medication guide to each patient. 1,000 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 75 mg 1000 tablets

PRINCIPAL DISPLAY PANEL NDC 50228-560-30 Brivaracetam Tablets CV 100 mg Dispense accompanying medication guide to each patient. 30 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 100 mg 30 tablets

PRINCIPAL DISPLAY PANEL NDC 50228-560-60 Brivaracetam Tablets CV 100 mg Dispense accompanying medication guide to each patient. 60 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 100 mg 60 tablets

PRINCIPAL DISPLAY PANEL NDC 50228-560-10 Brivaracetam Tablets CV 100 mg Dispense accompanying medication guide to each patient. 1,000 Tablets Rx Only ScieGen Pharmaceuticals Inc. PRINCIPAL DISPLAY PANEL - 100 mg 1000 tablets

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Brivaracetam — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Brivaracetam. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$3.08M
Claims incl. refills
4.1K
Beneficiaries
3.6K
Spend / beneficiary
$843.69
Spend / claim
$748.88
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ScieGen Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 tablets (50228-0559-30), 60 tablets (50228-0559-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
ScieGen Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 50228-0558-10 · ScieGen 50228-0560-10 · ScieGen →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.