Quick answers
- What is Clobazam used for?
- The FDA-approved label (Sympazan, Aquestive Therapeutics, December 1, 2025) says: “SYMPAZAN ® is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older. SYMPAZAN ® is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clobazam have a boxed warning?
- Yes. The FDA label for Sympazan has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Clobazam?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Clobazam been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started January 7, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Clobazam?
- 18 companies list prescription products of Clobazam in the FDA NDC Directory, including Ascend Laboratories, LLC, Aquestive Therapeutics and Lundbeck Pharmaceuticals LLC.
What Clobazam is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SYMPAZAN ® is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older. SYMPAZAN ® is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older.
— FDA label: Sympazan, Aquestive Therapeutics, effective December 1, 2025. Read the full label on DailyMed →
The FDA has 21 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.
This label has a boxed warning. Read it on the full label →
21 of 21 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| clobazam 10 mg film | Brand: Sympazan | $32.76 per unit |
| clobazam 10 mg tablet | Generic | $0.2438 per tablet |
| clobazam 10 mg tablet | Brand: Onfi | $29.89 per tablet |
| clobazam 2.5 mg/mL suspension | Generic | $0.1822 per mL |
| clobazam 2.5 mg/mL suspension | Brand: Onfi | $12.47 per mL |
| clobazam 20 mg film | Brand: Sympazan | $65.43 per unit |
| clobazam 20 mg tablet | Generic | $0.3762 per tablet |
| clobazam 20 mg tablet | Brand: Onfi | $59.79 per tablet |
| clobazam 5 mg film | Brand: Sympazan | $16.40 per unit |
NADAC list of November 4, 2026; these prices took effect between April 1, 2026 and 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.
- Ascend Laboratories, LLC4 products
- Aquestive Therapeutics3 products
- Lundbeck Pharmaceuticals LLC3 products
- Camber Pharmaceuticals, Inc.3 products
- NorthStar RxLLC3 products
- Amneal Pharmaceuticals NY LLC3 products
- Upsher-Smith Laboratories, LLC2 products
- Novadoz Pharmaceuticals LLC2 products
- Golden State Medical Supply, Inc.2 products
- Micro Labs Limited2 products
- Lupin Pharmaceuticals, Inc.2 products
- Bryant Ranch Prepack1 product
- Aurobindo Pharma Limited1 product
- American Health Packaging1 product
- Chartwell RX, LLC1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Bionpharma Inc.1 product
- Precision Dose, 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 |
|---|---|---|---|
| NDA202067 ONFI | Lundbeck Pharms LLC | October 21, 2011 | 8, latest March 12, 2024 2024: Labeling · 2023: Labeling · 2021: Labeling |
| NDA203993 ONFI | Lundbeck Pharms LLC | December 14, 2012 | 9, latest March 12, 2024 2024: Labeling · 2023: Labeling · 2021: Labeling |
| NDA210833 SYMPAZAN | Cosette | November 1, 2018 | 5, latest March 12, 2024 2024: Labeling · 2023: Labeling · 2021: Labeling |
Generic approvals (14)
- ANDA208819Bionpharma · October 22, 2018
- ANDA209687Upsher Smith Labs · October 22, 2018
- ANDA209718Amneal Pharms Co · October 22, 2018
- ANDA209795Hetero Labs Ltd III · October 22, 2018
- ANDA210039Amneal · October 22, 2018
- ANDA210545Lupin · December 14, 2018
- ANDA211711Micro Labs · January 30, 2019
- ANDA210978Taro · April 15, 2019
- ANDA212714Alkem Labs Ltd · September 6, 2019
- ANDA209796Hetero Labs Ltd III · February 24, 2020
- ANDA213110Chartwell Molecular · April 24, 2020
- ANDA213039Alkem Labs Ltd · May 6, 2021
- ANDA213404Msn · May 11, 2021
- ANDA214404Aurobindo Pharma Ltd · March 24, 2022
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.
-
January 7, 2025 · Class II · Ongoing · D-0201-2025
Presence of Foreign Tablets/Capsules
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11 — Amerisource Health Services LLC
-
December 13, 2024 · Class II · Ongoing · D-0184-2025
Presence of Foreign Tablets/Capsules
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21 — Amerisource Health Services LLC
-
February 12, 2024 · Class II · Ongoing · D-0348-2024
CGMP Deviations: Out of specification for residual solvents.
Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01 — Micro Labs Limited
-
July 16, 2019 · Class II · Terminated · D-1519-2019
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45. — Bionpharma 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) — Sympazan, Aquestive Therapeutics, effective December 1, 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 →