Quick answers
- What is Clonazepam used for?
- The FDA-approved label (Klonopin, H2-Pharma, LLC, December 1, 2025) says: “Seizure Disorders Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect ). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clonazepam have a boxed warning?
- Yes. The FDA label for Klonopin has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Clonazepam?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 23, 2026). Ask your pharmacist about alternatives.
- Has Clonazepam been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started November 18, 2024 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Clonazepam?
- 31 companies list prescription products of Clonazepam in the FDA NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc. and Aphena Pharma Solutions - Tennessee, LLC.
What Clonazepam is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Seizure Disorders Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect ). …
— FDA label: Klonopin, H2-Pharma, LLC, effective December 1, 2025. Read the full label on DailyMed →
The FDA has 93 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 →
71 of 93 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, orally disintegrating |
|---|---|
| Route | Oral |
| Prescription products | 145 in the FDA NDC Directory |
| Brand names | Klonopin |
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 |
|---|---|---|
| clonazepam 0.125 mg tablet, orally disintegrating | Generic | $0.4990 per tablet |
| clonazepam 0.25 mg tablet, orally disintegrating | Generic | $0.4288 per tablet |
| clonazepam 0.5 mg tablet | Generic | $0.0197 per tablet |
| clonazepam 0.5 mg tablet | Brand: Klonopin | $2.68 per tablet |
| clonazepam 0.5 mg tablet, orally disintegrating | Generic | $0.5267 per tablet |
| clonazepam 1 mg tablet | Generic | $0.0245 per tablet |
| clonazepam 1 mg tablet | Brand: Klonopin | $3.05 per tablet |
| clonazepam 1 mg tablet, orally disintegrating | Generic | $0.5435 per tablet |
| clonazepam 2 mg tablet | Generic | $0.0400 per tablet |
| clonazepam 2 mg tablet | Brand: Klonopin | $4.25 per tablet |
| clonazepam 2 mg tablet, orally disintegrating | Generic | $0.8962 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.
- Bryant Ranch Prepack20 products
- Remedyrepack Inc.12 products
- Aphena Pharma Solutions - Tennessee, LLC11 products
- Advagen Pharma Ltd9 products
- Teva Pharmaceuticals USA, Inc.8 products
- Proficient Rx LP6 products
- PD-Rx Pharmaceuticals, Inc.6 products
- Par Health USA, LLC5 products
- Alembic Pharmaceuticals Inc.5 products
- Preferred Pharmaceuticals Inc.5 products
- Alembic Pharmaceuticals Limited5 products
- Clinical Solutions Wholesale, LLC4 products
- Coupler LLC4 products
- Advanced Rx Pharmacy of Tennessee, LLC4 products
- NorthStar Rx LLC3 products
- Solco Healthcare LLC3 products
- A-S Medication Solutions3 products
- AvPAK3 products
- H2-Pharma, LLC3 products
- NuCare Pharmaceuticals, Inc.3 products
- Unit Dose Solutions, Inc.3 products
- Accord Healthcare Inc.3 products
- Chartwell RX, LLC3 products
- Aurobindo Pharma Limited3 products
- Cardinal Health 107, LLC2 products
- American Health Packaging2 products
- Direct_Rx2 products
- Major Pharmaceuticals2 products
- Advanced Rx of Tennessee, LLC1 product
- TruPharma, LLC1 product
- St Marys Medical Park Pharmacy1 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 |
|---|---|---|---|
| NDA017533 KLONOPIN | Cheplapharm | June 4, 1975 | 50, latest January 13, 2023 2023: Labeling · 2021: Labeling · 2017: Labeling |
Generic approvals (10)
- ANDA074569Teva · September 10, 1996
- ANDA074925Chartwell Rx · September 30, 1997
- ANDA075150Aurobindo Pharma USA · October 5, 1998
- ANDA075468Rubicon Research · October 6, 2000
- ANDA077147Accord Hlthcare · May 2, 2005
- ANDA077171Ph Health · August 3, 2005
- ANDA077194Barr · August 10, 2005
- ANDA077856Prinston Inc · June 28, 2006
- ANDA211033Alembic · June 28, 2019
- ANDA216988Rubicon Research · May 21, 2026
Shortage status
Current shortage · updated October 23, 2026 · first posted March 10, 2023
| Product | Clonazepam, Tablet, 1 mg (NDC 0093-3212-01) |
|---|---|
| Availability | Available |
| Company | Teva Pharmaceuticals USA, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
November 18, 2024 · Class I · Ongoing · D-0180-2025
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 — Endo USA, Inc.
-
November 18, 2024 · Class I · Ongoing · D-0178-2025
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (cart — Endo USA, Inc.
-
November 18, 2024 · Class I · Ongoing · D-0179-2025
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 — Endo USA, Inc.
-
November 18, 2024 · Class I · Ongoing · D-0181-2025
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (ca — Endo USA, Inc.
-
July 10, 2024 · Class I · Terminated · D-0622-2024
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02. — Endo Pharmaceuticals, 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) — Klonopin, H2-Pharma, LLC, 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 →