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Chlordiazepoxide Hydrochloride 10 mg Capsule, 30-count

by Clinical Solutions Wholesale, LLC · 30 CAPSULE in 1 BLISTER PACK (58118-1033-8)
NDC 58118-1033-08
🏷️ FDA NDC (as labeled) 58118-1033-8 billing pads the package segment with a zero
Rx only Generic On market CIV
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 58118-1033-8
Product NDC 58118-1033
11-digit billing NDC 58118103308
RxCUI 905369
UNII MFM6K1XWDK
Application # ANDA083116
SPL Set ID 74c4320d-c90d-436b-97da-07496ba88aed
Established class (EPC) Benzodiazepine
Chemical class Benzodiazepines
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-02-19
Route ORAL
Dosage form CAPSULE
Substance CHLORDIAZEPOXIDE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 58118-1033-8 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 58118-1033-08. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Benzodiazepine class.

Pharmacologic class Benzodiazepine
Drug family (ATC) Benzodiazepine derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerClinical Solutions Wholesale, LLC
Application holderBARR LABORATORIES INC
FDA applicationANDA083116 (ANDA)
Labeler code58118
First marketedFeb 2019
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio55 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Chlordiazepoxide is mainly used for three things: managing anxiety disorders or short-term anxiety symptoms, helping control withdrawal symptoms during acute alcohol detox, and red...
  • What exactly is chlordiazepoxide used for?
  • Please don't stop it suddenly — this is one of the most important things to know about this medication. Stopping abruptly can trigger severe withdrawal reactions, including seizure...
  • Can I stop taking it whenever I want if I feel better?
📖 Read our full Chlordiazepoxide guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2924 $8.77 / 30 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlordiazepoxide Hydrochloride 10 mg 00555-0033-02 Teva 100 capsules $0.143 AB Availability likely —
Chlordiazepoxide Hydrochloride 10 mg 42806-0562-01 Epic 100 capsules $0.143 AB Availability likely —
Chlordiazepoxide Hydrochloride 10 mg 51079-0375-20 Mylan 100 capsules $0.143 AB Availability likely —
Chlordiazepoxide Hydrochloride 10 mg 62135-0221-60 Chartwell 60 capsules $0.143 AB Availability likely —
Chlordiazepoxide Hydrochloride 10 mg 42806-0565-01 Epic 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride 10 mg 48433-0019-20 Safecor 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride 10 mgthis 58118-1033-08 Clinical 30 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride 10 mg 67046-0909-03 Coupler 30 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride 10 mg 70518-1752-01 REMEDYREPACK 30 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2019
On the market since
Feb 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for CHLORDIAZEPOXIDE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Nausea187
Diarrhoea186
Fatigue175
Pain137
Headache128
Dizziness116
Abdominal Pain113

Age at onset

Adolescent3
Adult104
Elderly95

Reporter sex

2,025 reports
Male · 20%
Female · 80%
Unknown · 0%

Serious outcomes

Hospitalization562
Death81
Disabling57
Life-threatening39
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 67 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
58118-1033-08 You're viewing this 30 CAPSULE in 1 BLISTER PACK (58118-1033-8) 2019-02-19 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 58118-1033-8, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 58118-1033-08, written without dashes as 58118103308. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 58118-1033-08, the first segment (58118) is the labeler code FDA assigned to Clinical Solutions Wholesale, LLC; the middle segment (1033) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Clinical Solutions Wholesale, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Clinical Solutions Wholesale, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 65 words ▾

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death [see WARNINGS , DRUG INTERACTIONS ]. Reserve concomitant prescribing of these drugs for use 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.

🎯 Indications and Usage 90 words ▾

INDICATIONS AND USAGE Chlordiazepoxide HCl 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 HCl 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.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Because of the wide range of clinical indications for chlordiazepoxide HCl, the optimum dosage varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. ADULTS USUAL DAILY DOSE Relief of Mild and Moderate Anxiety Disorders and Symptoms of Anxiety 5 mg or 10 mg, 3 or 4 times daily Relief of Severe Anxiety Disorders and Symptoms of Anxiety 20 mg or 25 mg, 3 or 4 times daily Geriatric Patients , or in the presence of debilitating disease.

5 mg, 2 to 4 times daily Preoperative Apprehension and Anxiety On days preceding surgery, 5 to 10 mg orally, 3 or 4 times daily. If used as preoperative medication, 50 to 100 mg IM 1 hour prior to surgery. PEDIATRIC PATIENTS USUAL DAILY DOSE Because of the varied response of pediatric patients to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as required.

Since clinical experience in pediatric patients under 6 years of age is limited, the use of the drug in this age group is not recommended. 5 mg, 2 to 4 times daily (may be increased in some pediatric patients to 10 mg, 2 to 3 times daily) For the relief of withdrawal symptoms of acute alcoholism, the parenteral form is usually used initially. If the drug is administered orally, the suggested initial dose is 50 to 100 mg, to be followed by repeated doses as needed until agitation is controlled — up to 300 mg per day.

Dosage should then be reduced to maintenance levels. .

⛔ Contraindications 14 words ▾

CONTRAINDICATIONS Chlordiazepoxide HCl capsules are contraindicated in patients with known hypersensitivity to the drug.

⚠️ Warnings ~1 min read ▾

WARNINGS Concomitant use of benzodiazepines, including chlordiazepoxide, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.

If a decision is made to prescribe chlordiazepoxide concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of chlordiazepoxide than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking chlordiazepoxide, prescribe a lower initial dose of the opioid and titrate based upon clinical response.

Advise both patients and caregivers about the risks of respiratory depression and sedation when chlordiazepoxide is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see DRUG INTERACTIONS ). Chlordiazepoxide HCl may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery.

Similarly, it may impair mental alertness in children. The concomitant use of alcohol or other central nervous system depressants may have an additive effect. PATIENTS SHOULD BE WARNED ACCORDINGLY.

🤒 Adverse Reactions 151 words ▾

ADVERSE REACTIONS The necessity of discontinuing therapy because of undesirable effects has been rare. Drowsiness, ataxia and confusion have been reported in some patients — particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges.

In a few instances syncope has been reported. Other adverse reactions reported during therapy include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido. Such side effects have been infrequent, and are generally controlled with reduction of dosage.

Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after chlordiazepoxide HCl treatment. Blood dyscrasias (including agranulocytosis), jaundice and hepatic dysfunction have occasionally been reported during therapy. When chlordiazepoxide HCl treatment is protracted, periodic blood counts and liver function tests are advisable.

🔄 Drug Interactions 78 words ▾

DRUG INTERACTIONS The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.

Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.

🧒 Pediatric Use 68 words ▾

Pediatric Use Because of the varied response of pediatric patients to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as required (see DOSAGE AND ADMINISTRATION). Since clinical experience with chlordiazepoxide HCl in pediatric patients under 6 years of age is limited, use in this age group is not recommended. Hyperactive aggressive pediatric patients should be monitored for paradoxical reactions to chlordiazepoxide HCl (see PRECAUTIONS).

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Manifestations of chlordiazepoxide overdosage includes somnolence, confusion, coma and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal following chlordiazepoxide HCl overdosage. General supportive measures should be employed, along with immediate gastric lavage.

Intravenous fluids should be administered and an adequate airway maintained. Hypotension may be combated by the use of norepinephrine or metaraminol. Dialysis is of limited value.

There have been occasional reports of excitation in patients following chlordiazepoxide HCl overdosage; if this occurs barbiturates should not be used. As with the management of intentional overdosage with any drug, it should be borne in mind that multiple agents may have been ingested. Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected.

Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression and other residual benzodiazepine effects for an appropriate period after treatment.

The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert, including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS, should be consulted prior to use.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Chlordiazepoxide HCl has antianxiety, sedative, appetite-stimulating and weak analgesic actions. The precise mechanism of action is not known. The drug blocks EEG arousal from stimulation of the brain stem reticular formation.

It takes several hours for peak blood levels to be reached and the half-life of the drug is between 24 and 48 hours. After the drug is discontinued plasma levels decline slowly over a period of several days. Chlordiazepoxide is excreted in the urine, with 1% to 2% unchanged and 3% to 6% as conjugate.

Animal Pharmacology The drug has been studied extensively in many species of animals and these studies are suggestive of action on the limbic system of the brain, which recent evidence indicates is involved in emotional responses. Hostile monkeys were made tame by oral drug doses which did not cause sedation. Chlordiazepoxide HCl revealed a “taming” action with the elimination of fear and aggression.

The taming effect of chlordiazepoxide HCl was further demonstrated in rats made vicious by lesions in the septal area of the brain. The drug dosage which effectively blocked the vicious reaction was well below the dose which caused sedation in these animals. The LD 50 of parenterally administered chlordiazepoxide HCl was determined in mice (72 hours) and rats (5 days), and calculated according to the method of Miller and Tainter, with the following results: mice, IV, 123 ± 12 mg/kg; mice, IM, 366 ± 7 mg/kg; rats, IV, 120 ± 7 mg/kg; rats, IM, > 160 mg/kg.

Effects on Reproduction Reproduction studies in rats fed 10, 20 and 80 mg/kg daily and bred through one or two matings showed no congenital anomalies, nor were there adverse effects on lactation of the dams or growth of the newborn. However, in another study at 100 mg/kg daily there was noted a significant decrease in the fertilization rate and a marked decrease in the viability and body weight of off-spring which may be attributable to sedative activity, thus resulting in lack of interest in mating and lessened maternal nursing and care of the young.

One neonate in each of the first and second matings in the rat reproduction study at the 100 mg/kg dose exhibited major skeletal defects. Further studies are in progress to determine the significance of these findings.

📦 How Supplied / Storage and Handling 209 words ▾

HOW SUPPLIED Chlordiazepoxide Hydrochloride Capsules USP, 5 mg are available as a two-piece hard gelatin capsule with an aqua green opaque cap and a yellow opaque body filled with white powder, imprinted in black ink “stylized barr” 158, packaged in bottles of 100 (NDC 0555-0158-02) and 500 (NDC 0555-0158-04) capsules. Chlordiazepoxide Hydrochloride Capsules USP, 10 mg are available as a two-piece hard gelatin capsule with a black opaque cap and a green opaque body filled with white powder, imprinted in white ink “stylized barr” 033, packaged in bottles of 100 (NDC 0555-0033-02) and 1000 (NDC 0555-0033-05) capsules.

Chlordiazepoxide Hydrochloride Capsules USP, 25 mg are available as a two-piece hard gelatin capsule with an aqua green opaque cap and a white opaque body filled with white powder, imprinted in black ink “stylized barr” 159, available in bottles of 100 (NDC 0555-0159-02) and 500 (NDC 0555-0159-04) capsules. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev.

D 8/2016 Repackaged by: Clinical Solutions Wholesale Franklin, TN 37067

📋 Description ~1 min read ▾

DESCRIPTION Chlordiazepoxide hydrochloride is the prototype for the benzodiazepine compounds. It is a versatile therapeutic agent of proven value for the relief of anxiety. Chlordiazepoxide hydrochloride is among the safer of the effective psychopharmacologic compounds available, as demonstrated by extensive clinical evidence.

Chlordiazepoxide hydrochloride is 7-chloro-2- (methylamino)-5-phenyl-3 H -1,4-benzodiazepine 4-oxide hydrochloride. A white to practically white crystalline substance, it is soluble in water. It is unstable in solution and the powder must be protected from light.

The structural formula is: C 16 H 14 ClN 3 O • HCl M.W. 336.22 Each capsule, for oral administration, contains either 5 mg, 10 mg or 25 mg of chlordiazepoxide hydrochloride, USP and has the following inactive ingredients: anhydrous lactose, D&C yellow no. 10, FD&C blue no.

1, FD&C blue no. 1 aluminum lake, gelatin, hydrogenated vegetable oil, microcrystalline cellulose, pharmaceutical glaze, and titanium dioxide. The 5 mg and 25 mg also contain D&C yellow no.

10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol, and synthetic black iron oxide.

In addition, the 5 mg contains D&C red no. 33 and the 10 mg also contains butyl paraben, edetate calcium disodium, dimethyl polysiloxane, ethylene glycol monoethyl ether, FD&C red no. 40, methyl paraben, propyl paraben, sodium, sodium lauryl sulfate, sodium propionate, and soya lecithin.

Chlordiazepoxide hydrochloride structural formula

💬 Information for Patients 44 words ▾

Information for Patients To assure the safe and effective use of benzodiazepines, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE MEDICATION GUIDE Chlordiazepoxide (KLOR-dye-AZ-e-POX-ide) Hydrochloride Capsules, C-IV What is the most important information I should know about chlordiazepoxide? Chlordiazepoxide is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death.

Chlordiazepoxide can make you sleepy or dizzy, and can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how chlordiazepoxide affects you. Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking chlordiazepoxide without first talking to your healthcare provider.

When taken with alcohol or drugs that cause sleepiness or dizziness, chlordiazepoxide may make your sleepiness or dizziness much worse. Do not take more chlordiazepoxide than prescribed. What is chlordiazepoxide?

Chlordiazepoxide is a prescription medicine used: to treat anxiety disorders for the short-term relief of the symptoms of anxiety to treat withdrawal symptoms of acute alcoholism preoperatively to treat apprehension and anxiety Chlordiazepoxide is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep chlordiazepoxide in a safe place to prevent misuse and abuse. Selling or giving away chlordiazepoxide may harm others, and is against the law.

Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs. It is not known if chlordiazepoxide is safe and effective in children under 6 years of age. It is not known if chlordiazepoxide is safe and effective for use for longer than 4 months.

Do not take chlordiazepoxide if you are allergic to chlordiazepoxide or to any of the ingredients in chlordiazepoxide hydrochloride capsules. See the end of this Medication Guide for a complete list of ingredients in chlordiazepoxide hydrochloride capsules. Before you take chlordiazepoxide, tell your healthcare provider about all of your medical conditions, including if you: have or have had depression, mood problems, or suicidal thoughts or behavior have a history of drug or alcohol abuse or addiction have liver or kidney problems are pregnant or plan to become pregnant.

Chlordiazepoxide may harm your unborn baby. You and your healthcare provider should decide if you should take chlordiazepoxide while you are pregnant are breastfeeding or plan to breastfeed. Chlordiazepoxide may pass into your breast milk and may harm your baby.

Talk to your healthcare provider about the best way to feed your baby if you take chlordiazepoxide. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking chlordiazepoxide with certain other medicines can cause side effects or affect how well chlordiazepoxide or the other medicines work.

Do not start or stop other medicines without talking to your healthcare provider. How should I take chlordiazepoxide? Take chlordiazepoxide exactly as your healthcare provider tells you to take it.

Your healthcare provider will tell you how much chlordiazepoxide to take and when to take it. If you take too much chlordiazepoxide, call your healthcare provider or go to the nearest hospital emergency room right away. What should I avoid while taking chlordiazepoxide?

Chlordiazepoxide can cause you to be drowsy. Do not drive a car or operate heavy machinery until you know how chlordiazepoxide affects you. You should not drink alcohol while taking chlordiazepoxide.

Drinking alcohol can increase your chances of having serious side effects. What are the possible side effects of chlordiazepoxide? Chlordiazepoxide may cause serious side effects, including: See “What is the most important information I should know about chlordiazepoxide?” Abuse and de…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58118-0904-08 · Clinical 58118-1095-08 · Clinical →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.