Quick answers
- What is Brivaracetam used for?
- The FDA-approved label (Briviact, UCB, Inc., August 20, 2026) says: “BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Brivaracetam have a boxed warning?
- No. None of the 19 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Brivaracetam?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Brivaracetam been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 15, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Brivaracetam?
- 17 companies list prescription products of Brivaracetam in the FDA NDC Directory, including Novadoz Pharmaceuticals LLC, UCB, Inc. and Aurobindo Pharma Limited.
What Brivaracetam is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
— FDA label: Briviact, UCB, Inc., effective August 20, 2026. Read the full label on DailyMed →
The FDA has 19 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 19 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Solution · Tablet · Injection · Injection, solution · Injection, suspension |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 62 in the FDA NDC Directory |
| Brand names | Briviact |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| brivaracetam 10 mg tablet, film coated | Brand: Briviact | $24.01 per tablet |
| brivaracetam 10 mg/mL solution | Generic | $0.2757 per mL |
| brivaracetam 10 mg/mL solution | Brand: Briviact | $4.81 per mL |
| brivaracetam 100 mg tablet | Generic | $0.2526 per tablet |
| brivaracetam 100 mg tablet, film coated | Generic | $0.2526 per tablet |
| brivaracetam 100 mg tablet, film coated | Brand: Briviact | $24.07 per tablet |
| brivaracetam 25 mg tablet | Generic | $0.2089 per tablet |
| brivaracetam 25 mg tablet, film coated | Generic | $0.2089 per tablet |
| brivaracetam 25 mg tablet, film coated | Brand: Briviact | $24.05 per tablet |
| brivaracetam 50 mg tablet | Generic | $0.1722 per tablet |
| brivaracetam 50 mg tablet, film coated | Generic | $0.1722 per tablet |
| brivaracetam 50 mg tablet, film coated | Brand: Briviact | $24.07 per tablet |
| brivaracetam 75 mg tablet | Generic | $0.2659 per tablet |
| brivaracetam 75 mg tablet, film coated | Generic | $0.2659 per tablet |
| brivaracetam 75 mg tablet, film coated | Brand: Briviact | $24.05 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Novadoz Pharmaceuticals LLC7 products
- UCB, Inc.7 products
- Aurobindo Pharma Limited6 products
- Zydus Pharmaceuticals USA Inc.5 products
- Zydus Lifesciences Limited5 products
- SolarisPharmaCorporation5 products
- Exelan Pharmaceuticals Inc.5 products
- Apotex Corp.5 products
- ScieGen Pharmaceuticals, Inc.5 products
- AvKARE4 products
- PAI Holdings, LLC dba PAI Pharma2 products
- Zhejiang Poly Pharm. Co., Ltd.1 product
- Ascend Laboratories, LLC1 product
- Micro Labs Limited1 product
- Hainan Poly Pharm. Co., Ltd.1 product
- Florida Pharmaceutical Products, LLC1 product
- Lupin Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA205836 BRIVIACT | Ucb Inc | February 18, 2016 | 7, latest August 28, 2025 2025: Labeling · 2023: Labeling · 2021: Labeling |
| NDA205837 BRIVIACT | Ucb Inc | February 18, 2016 | 7, latest August 28, 2025 2025: Labeling · 2023: Labeling · 2021: Labeling |
| NDA205838 BRIVIACT | Ucb Inc | February 18, 2016 | 7, latest August 28, 2025 2025: Labeling · 2023: Labeling · 2021: Labeling |
Generic approvals (15)
- ANDA214748Sunshine · June 9, 2022
- ANDA214501Zydus Pharms · October 3, 2022
- ANDA214848Aurobindo Pharma Ltd · January 6, 2023
- ANDA214921Msn · November 13, 2025
- ANDA214922Msn · February 19, 2026
- ANDA214875Apotex · February 23, 2026
- ANDA214880Micro Labs · February 23, 2026
- ANDA214924Msn · February 23, 2026
- ANDA218249Hainan Poly · February 23, 2026
- ANDA218494Zhejiang Poly Pharm · February 23, 2026
- ANDA219772Alkem Labs Ltd · February 23, 2026
- ANDA220164Lupin · February 23, 2026
- ANDA220385Regcon Holdings · February 23, 2026
- ANDA219952Sciegen Pharms · July 1, 2026
- ANDA220288Aurobindo Pharma · August 10, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 15, 2021 · Class II · Terminated · D-0591-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66 — Cardinal Health Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Briviact, UCB, Inc., effective August 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →