Prescription medicine
Clorazepate First approved as Tranxene
Clorazepate (Tranxene) is a prescription medicine with an FDA approval on record since 1972. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $0.524 per clorazepate 3.75 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the clorazepate FDA label on DailyMed (effective September 10, 2026, Apotex Corp.); the NDA 17105 record on Drugs@FDA; every clorazepate label on DailyMed.
Highlights of the record
FDA label of September 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION.
and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (See WARNINGS and PRECAUTIONS). The use of benzodiazepines, including clorazepate dipotassium tablets, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing clorazepate dipotassium tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (See WARNINGS). The continued use of benzodiazepines, including clorazepate dipotassium tablets, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. […]
Used for
From the label: indications and usageClorazepate dipotassium tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
Forms and strengths
- 3.75 mg
- 7.5 mg
- 15 mg
Tablet.
On the market
- Earliest approval on file
- June 23, 1972 Tranxene, Ajenat Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 36 first June 26, 1987; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 8 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.524 per tablet Clorazepate 3.75 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2024 0 Class I among all firms' recalls; latest April 24, 2024
- FAERS reports
- 1,945 through July 30, 2026
What is clorazepate used for?
From the label: indications and usageClorazepate 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. The effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. […]
Conditions named in the indications of clorazepate's FDA labels, with every medicine labeled for each:
From other clorazepate labelsAnxiety: INDICATIONS AND USAGE Clorazepate dipotassium tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
FDA pharmacologic class: Benzodiazepine.
Source: FDA drug label (Clorazepate Dipotassium), ANDA215566 (Corepharma), as published by Apotex Corp., effective September 10, 2026 (SPL set 6e07efe5-29b6-6d1e-661a-f696c4b17f43), via openFDA; the full label on DailyMed
What does the patient leaflet for clorazepate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about clorazepate dipotassium tablets?Clorazepate dipotassium is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens: shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking clorazepate dipotassium tablets and opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including clorazepate dipotassium tablets which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including clorazepate dipotassium tablets. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. You can develop an addiction even if you take clorazepate dipotassium tablets as prescribed by your healthcare provider Take clorazepate dipotassium tablets exactly as your healthcare provider prescribed. Do not share your clorazepate dipotassium tablets with other people. Keep clorazepate dipotassium tablets in a safe place and away from children. Physical dependence and withdrawal reactions. Clorazepate dipotassium tablets can cause physical dependence and withdrawal reactions,. Do not suddenly stop taking clorazepate dipotassium tablets. […]
From the patient leaflet: How should I store clorazepate dipotassium tablets?Store clorazepate dipotassium tablets at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Keep clorazepate dipotassium tablets in a tightly closed container, dry, and out of the light. Keep clorazepate dipotassium tablets and all medicines out of the reach of children. General Information about the safe and effective use of clorazepate dipotassium tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use clorazepate dipotassium tablets for a condition for which it was not prescribed. Do not give clorazepate dipotassium tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about clorazepate dipotassium tablets that is written for health professionals.
Source: FDA drug label (Clorazepate Dipotassium), ANDA215566 (Corepharma), as published by Apotex Corp., effective September 10, 2026 (SPL set 6e07efe5-29b6-6d1e-661a-f696c4b17f43), via openFDA; the full label on DailyMed
Is there a generic for clorazepate (Tranxene)?
The FDA approved the first generic clorazepate on June 26, 1987. 36 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists clorazepate from 8 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1972 earliest approval on file
- 1987 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for clorazepate (Tranxene)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.524 per Clorazepate 3.75 mg tablet, down 39% from $0.854 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Clorazepate 3.75 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Clorazepate 15 mg tablet | Generic | $0.808 per tablet | $24.24 | -53% |
| Clorazepate 3.75 mg tablet | Generic | $0.524 per tablet | $15.72 | -39% |
| Clorazepate 7.5 mg tablet | Generic | $0.839 per tablet | $25.16 | -20% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has clorazepate been recalled?
The FDA's Enforcement Report lists 2 recalls naming clorazepate since 2024: 0 Class I (the most serious), 2 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 24, 2024 | Class II | Aurobindo Pharma USA Inc. | Discoloration: Dotted and yellow spots on tablets |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the clorazepate label say about other medicines?
The clorazepate label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name clorazepate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Chlordiazepoxide | drug interactions | Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. |
| Chlorpromazine | drug interactions | Animal experience indicates that clorazepate dipotassium prolongs the sleeping time after hexobarbital or after ethyl alcohol, increases the inhibitory effects of chlorpromazine, but does not exhibit monoamine oxidase inhibition. |
| Diazepam | drug interactions | Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. |
| Ethyl alcohol | drug interactions | Animal experience indicates that clorazepate dipotassium prolongs the sleeping time after hexobarbital or after ethyl alcohol, increases the inhibitory effects of chlorpromazine, but does not exhibit monoamine oxidase inhibition. |
| Flumazenil | warnings | Abrupt discontinuation or rapid dosage reduction of clorazepate dipotassium tablets after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE: |
Other labels that name clorazepate
Source: FDA drug label (Clorazepate Dipotassium), ANDA215566 (Corepharma), as published by Apotex Corp., effective September 10, 2026 (SPL set 6e07efe5-29b6-6d1e-661a-f696c4b17f43), via openFDA; the full label on DailyMed
What do FAERS reports show for clorazepate?
The FDA Adverse Event Reporting System holds 1,945 reports that list clorazepate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 256 are coded as a death and 983 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as clorazepate?
11 other medicines are given the same way (oral) and in the same FDA class as clorazepate or labeled mainly for the same use (anxiety), the same class first. Anxiety lists all 22 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Clonazepam | Anxiety, Seizures and epilepsy | 31 labelers | $0.0244 per tablet 1 mg tablet | In shortage |
| Alprazolam | Anxiety | 30 labelers | $0.0236 per tablet 0.25 mg tablet | No current entry |
| Lorazepam | Anxiety | 33 labelers | $0.0344 per tablet 0.5 mg tablet | In shortage |
| Diazepam | Anxiety | 32 labelers | $0.0283 per tablet 10 mg tablet | No current entry |
| Chlordiazepoxide | Anxiety | 15 labelers | $0.158 per capsule 25 mg capsule | No current entry |
| Oxazepam | Anxiety | 6 labelers | $0.725 per capsule 10 mg capsule | No current entry |
| Amitriptyline and chlordiazepoxide | Anxiety | 1 labeler | $1.20 per unit 5-12.5 | No current entry |
| Buspirone | Anxiety | 49 labelers | $0.043 per tablet 15 mg tablet | No current entry |
Every medicine labeled for the same conditions as clorazepate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does clorazepate compare with medicines for the same use?
4 side-by-side pages set clorazepate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to clorazepate
- 11 medicines for the same use
- Other benzodiazepines
- the pharmacologic class, with prices and generics
- Clorazepate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other