Quick answers
- What is Clorazepate dipotassium used for?
- The FDA-approved label (Clorazepate Dipotassium, Apotex Corp., September 10, 2026) says: “Clorazepate dipotassium tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clorazepate dipotassium have a boxed warning?
- Yes. The FDA label for Clorazepate Dipotassium has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Clorazepate dipotassium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Clorazepate dipotassium been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started April 24, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Clorazepate dipotassium?
- 8 companies list prescription products of Clorazepate dipotassium in the FDA NDC Directory, including Aurolife Pharma, LLC, Apotex Corp. and Coupler LLC.
What Clorazepate dipotassium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Clorazepate dipotassium tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. …
— FDA label: Clorazepate Dipotassium, Apotex Corp., effective September 10, 2026. Read the full label on DailyMed →
The FDA has 10 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 →
10 of 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 25 in the FDA NDC Directory |
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 |
|---|---|---|
| clorazepate dipotassium 15 mg tablet | Generic | $0.7718 per tablet |
| clorazepate dipotassium 15 mg/mg tablet | Generic | $0.7718 per tablet |
| clorazepate dipotassium 3.75 mg tablet | Generic | $0.5189 per tablet |
| clorazepate dipotassium 3.75 mg/mg tablet | Generic | $0.5189 per tablet |
| clorazepate dipotassium 7.5 mg tablet | Generic | $0.7773 per tablet |
| clorazepate dipotassium 7.5 mg/mg tablet | Generic | $0.7773 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.
- Aurolife Pharma, LLC6 products
- Apotex Corp.3 products
- Coupler LLC3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Clinical Solutions Wholesale, LLC3 products
- ANI Pharmaceuticals, Inc.3 products
- NorthStar Rx LLC3 products
- PD-Rx Pharmaceuticals, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (4)
- ANDA071858Aurobindo Pharma · July 17, 1987
- ANDA075731Taro · April 27, 2000
- ANDA215566Macleods Pharms · June 14, 2022
- ANDA213730Novitium Pharma · June 16, 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.
-
April 24, 2024 · Class II · Ongoing · D-0492-2024
Discoloration: Dotted and yellow spots on tablets
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, E — Aurobindo Pharma USA Inc.
-
April 24, 2024 · Class II · Ongoing · D-0491-2024
Discoloration: Dotted and yellow spots on tablets
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, E — Aurobindo Pharma USA 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
| RxCUI (RxNorm) | 197464, 197465, 197466 |
|---|---|
| SPL set ID of the quoted label | 6e07efe5-29b6-6d1e-661a-f696c4b17f43 |
| FDA labels (SPL) | 10 |
| FDA applications | 4 ANDA |
| Active ingredients (FDA) | CLORAZEPATE DIPOTASSIUM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Clorazepate Dipotassium, Apotex Corp., effective September 10, 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 →