Quick answers
- What is Felbamate used for?
- The FDA-approved label (Felbatol, Viatris Specialty LLC, August 15, 2025) says: “Felbatol ® is not indicated as a first line antiepileptic treatment (see Warnings ). Felbatol ® is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Felbamate have a boxed warning?
- Yes. The FDA label for Felbatol has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Felbamate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Felbamate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Felbamate?
- 10 companies list prescription products of Felbamate in the FDA NDC Directory, including Bryant Ranch Prepack, Sun Pharmaceutical Industries, Inc. and Amneal Pharmaceuticals LLC.
What Felbamate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Felbatol ® is not indicated as a first line antiepileptic treatment (see Warnings ). Felbatol ® is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. …
— FDA label: Felbatol, Viatris Specialty LLC, effective August 15, 2025. Read the full label on DailyMed →
The FDA has 15 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
14 of 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Suspension |
|---|---|
| Route | Oral |
| Prescription products | 22 in the FDA NDC Directory |
| Brand names | Felbatol |
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 |
|---|---|---|
| felbamate 400 mg tablet | Generic | $0.8512 per tablet |
| felbamate 400 mg tablet | Brand: Felbatol | $14.70 per tablet |
| felbamate 600 mg tablet | Generic | $1.05 per tablet |
| felbamate 600 mg tablet | Brand: Felbatol | $16.83 per tablet |
| felbamate 600 mg/5 mL suspension | Generic | $0.3710 per mL |
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.
- Bryant Ranch Prepack4 products
- Sun Pharmaceutical Industries, Inc.3 products
- Amneal Pharmaceuticals LLC3 products
- Viona Pharmaceuticals Inc2 products
- Amneal Pharmaceuticals of New York LLC2 products
- Viatris Specialty LLC2 products
- ANI Pharmaceuticals, Inc.2 products
- Zydus Lifesciences Limited2 products
- NorthStar Rx LLC1 product
- Novitium Pharma LLC1 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 |
|---|---|---|---|
| NDA020189 FELBATOL | Mylan Speciality LP | July 29, 1993 | 16, latest August 31, 2012 2012: Labeling · 2011: Labeling · 2009: Labeling |
Generic approvals (7)
- ANDA201680Amneal Pharms · September 13, 2011
- ANDA202385Amneal Pharms · December 16, 2011
- ANDA202284Ani Pharms · November 4, 2015
- ANDA207093Taro · April 20, 2017
- ANDA208970Zydus Lifesciences · May 30, 2017
- ANDA206314Taro · June 16, 2017
- ANDA211333Novitium Pharma · May 31, 2019
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Felbatol, Viatris Specialty LLC, effective August 15, 2025; 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 →