Prescription medicine
Chlordiazepoxide First approved as Librium
Chlordiazepoxide (Librium) is a prescription medicine with an FDA approval on record since 1960. FDA's NDC Directory lists it from 15 generic labelers, and pharmacies paid $0.158 per chlordiazepoxide 25 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the chlordiazepoxide FDA label on DailyMed (effective December 10, 2025, Chartwell RX, LLC); the NDA 12249 record on Drugs@FDA; every chlordiazepoxide label on DailyMed.
Highlights of the record
FDA label of December 10, 2025; 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 for 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 chlordiazepoxide hydrochloride capsules, exposes users to risk 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 chlordiazepoxide hydrochloride capsules and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ). The continued use of benzodiazepines, including chlordiazepoxide hydrochloride capsules, may lead to clinically significant physical dependence. The risk of dependence and withdrawal increase with longer treatment duration and higher daily dose. […]
Used for
From the label: indications and usageChlordiazepoxide Hydrochloride Capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety.
Forms and strengths
- 5 mg
- 10 mg
- 25 mg
Capsule; gelatin-coated capsule.
On the market
- Earliest approval on file
- February 24, 1960 Librium, Valeant Pharm Intl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 51 first March 7, 1975; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 15 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.158 per capsule Chlordiazepoxide 25 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 107 through July 30, 2026
What is chlordiazepoxide used for?
From the label: indications and usageChlordiazepoxide Hydrochloride Capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide hydrochloride capsules in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
Conditions named in the indications of chlordiazepoxide's FDA labels, with every medicine labeled for each:
From other chlordiazepoxide labelsAnxiety and Alcohol use disorder: INDICATIONS AND USAGE Chlordiazepoxide Hydrochloride Capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension …
FDA pharmacologic class: Benzodiazepine.
Source: FDA drug label (Chlordiazepoxide Hydrochloride), Chartwell RX, LLC, effective December 10, 2025 (SPL set dd5f82b0-5a56-4728-941a-c8c2a0d51cc4), via openFDA; the full label on DailyMed
What does the patient leaflet for chlordiazepoxide 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 chlordiazepoxide hydrochloride?Chlordiazepoxide Hydrochloride is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (CNS) (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 chlordiazepoxide hydrochloride with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including chlordiazepoxide hydrochloride, 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 chlordiazepoxide hydrochloride. 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 chlordiazepoxide hydrochloride exactly as prescribed by your healthcare provider. Take chlordiazepoxide hydrochloride exactly as your healthcare provider prescribed. Do not share your chlordiazepoxide hydrochloride with other people. Keep chlordiazepoxide hydrochloride in a safe place and away from children. Physical dependence and withdrawal reactions. […]
From the patient leaflet: How should I store chlordiazepoxide hydrochloride?Store chlordiazepoxide hydrochloride at room temperature between 68°F to 77°F (20°C to 25°C). Keep chlordiazepoxide hydrochloride in a tightly closed container and out of the light. Keep chlordiazepoxide hydrochloride and all medicines out of the reach of children.
Source: FDA drug label (Chlordiazepoxide Hydrochloride), Chartwell RX, LLC, effective December 10, 2025 (SPL set dd5f82b0-5a56-4728-941a-c8c2a0d51cc4), via openFDA; the full label on DailyMed
Is there a generic for chlordiazepoxide (Librium)?
The FDA approved the first generic chlordiazepoxide on March 7, 1975. 51 generic applications are approved; 9 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 chlordiazepoxide from 15 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.
- 1960 earliest approval on file
- 1975 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 chlordiazepoxide (Librium)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.158 per Chlordiazepoxide 25 mg capsule, down 2% from $0.161 on October 8, 2025. 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.
- Chlordiazepoxide 25 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Chlordiazepoxide 10 mg capsule | Generic | $0.143 per capsule | $4.30 | +2% |
| Chlordiazepoxide 25 mg capsule | Generic | $0.158 per capsule | $4.75 | -2% |
| Chlordiazepoxide 5 mg capsule | Generic | $0.187 per capsule | $5.60 | +1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has chlordiazepoxide been recalled?
The FDA's Enforcement Report lists 1 recall naming chlordiazepoxide since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of chlordiazepoxide and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: chlordiazePOXIDE HCl, Capsule, 25 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 50 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the chlordiazepoxide label say about other medicines?
The chlordiazepoxide label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 10 other medicines name chlordiazepoxide. 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 |
|---|---|---|
| Flumazenil | warnings | Abrupt discontinuation or rapid dosage reduction of chlordiazepoxide 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 chlordiazepoxide
Source: FDA drug label (Chlordiazepoxide Hydrochloride), Chartwell RX, LLC, effective December 10, 2025 (SPL set dd5f82b0-5a56-4728-941a-c8c2a0d51cc4), via openFDA; the full label on DailyMed
What do FAERS reports show for chlordiazepoxide?
The FDA Adverse Event Reporting System holds 107 reports that list chlordiazepoxide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 13 are coded as a death and 35 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.
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 chlordiazepoxide?
10 other medicines are given the same way (oral) and in the same FDA class as chlordiazepoxide 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 | 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 |
| Clorazepate | Anxiety | 8 labelers | $0.524 per tablet 3.75 mg tablet | No current entry |
| Oxazepam | Anxiety | 6 labelers | $0.725 per capsule 10 mg capsule | No current entry |
| Buspirone | Anxiety | 49 labelers | $0.043 per tablet 15 mg tablet | No current entry |
| Hydroxyzine | Anxiety | 59 labelers | $0.0326 per tablet 25 mg tablet | No current entry |
Every medicine labeled for the same conditions as chlordiazepoxide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does chlordiazepoxide compare with medicines for the same use?
5 side-by-side pages set chlordiazepoxide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to chlordiazepoxide
- 10 medicines for the same use
- Other benzodiazepines
- the pharmacologic class, with prices and generics
- Chlordiazepoxide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other