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Chlordiazepoxide Hydrochloride 25 mg Capsule, 30-count — NDC 58118-1590-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Chlordiazepoxide Hydrochloride 25 mg Capsule, 30-count — NDC 58118-1590-8 (Billing 58118-1590-08)

by Clinical Solutions Wholesale, LLC · 30 CAPSULE in 1 BLISTER PACK

This is a package of 30 capsules of Chlordiazepoxide Hydrochloride 25 mg Capsule from Clinical Solutions Wholesale, LLC, marketed since Dec 2018 and currently FDA-listed. It is this product's only package size.

NDC 58118-1590-08
🏷️ FDA NDC (as labeled) 58118-1590-8 billing pads the package segment with a zero
Rx only Generic On market CIV ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 58118-1590-8 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
58118 labeler · 1590 product · 8 package
Package marketed since
Dec 12, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5811815908 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58118-1590-8
Product NDC 58118-1590
11-digit billing NDC 58118159008
RxCUI 905495
UNII MFM6K1XWDK
Application # ANDA084769
SPL Set ID 3d4cab96-8a67-4d26-a9cc-b1a02fb6c146
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 2018-12-12
Route ORAL
Dosage form CAPSULE
Substance CHLORDIAZEPOXIDE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 905495
Why two NDCs? The FDA registers this code as 58118-1590-8 — 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 → 58118-1590-08. 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.

Clinical

📖 What it is MedlinePlus · NLM

Chlordiazepoxide is used to relieve anxiety and to control agitation caused by alcohol withdrawal. Chlordiazepoxide is in a class of medications called benzodiazepines. It works by decreasing abnormal electrical activity in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Chlordiazepoxide is mainly used for three things: managing anxiety disorders, easing the symptoms of going through alcohol withdrawal, and calming pre-surgery anxiety. It's not mea...
  • What exactly is chlordiazepoxide used for?
  • Please don't stop on your own — this is one of the most important things to know about this medicine. Your body can become physically dependent on chlordiazepoxide, and stopping su...
  • 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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
58118-1590-08 You're viewing this Main listing 30 CAPSULE in 1 BLISTER PACK 2018-12-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlordiazepoxide Hydrochloride 25 mg 00555-0159-02 Teva 100 capsules $0.158 AB Availability likely —
Chlordiazepoxide Hydrochloride 25 mg 51079-0141-20 Mylan 100 capsules $0.158 AB Availability likely —
Chlordiazepoxide Hydrochloride 25 mg 60687-0807-01 American 100 capsules $0.158 AB Availability likely —
Chlordiazepoxide Hydrochloride 25 mg 62135-0222-60 Chartwell 60 capsules $0.158 AB Availability likely —
Chlordiazepoxide Hydrochloride 25 mg 42806-0563-01 Epic 100 capsules $0.160 AB Availability likely —
Chlordiazepoxide Hydrochloride 25 mg 42806-0566-01 Epic 100 capsules $0.160 AB Availability likely —
Chlordiazepoxide Hydrochloride 25 mg 43063-0046-03 PD-Rx 3 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride 25 mg 48433-0020-20 Safecor 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride 25 mgthis 58118-1590-08 Clinical 30 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride 25 mg 67046-0910-03 Couper 30 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride 25 mg 68071-5171-03 NuCare 30 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride 25 mg 68071-5256-06 NuCare 6 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride 25 mg 70518-0015-00 REMEDYREPACK 30 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride 25 mg 70518-0157-01 REMEDYREPACK 100 capsules — AB Discontinued —
Chlordiazepoxide Hydrochloride 25 mg 87441-0015-01 Unit 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

🏛️
2018
On the market since
Dec 2018
📍
2026
Currently FDA-listed
8 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.

What it looks like

Color green / white
ShapeCapsule
Imprintbarr;159
Size14 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII Z82Y2C65EA
    Hydrogenated cottonseed oil is a solid fat made by adding hydrogen to cottonseed oil. It's used in medicines as a binder and lubricant to help hold ingredients together and make tablets easier to compress and release.
  • UNII D3741U8K7L
    A blue colorant derived from indigo dye. It's added to tablets and capsules to provide color identification and improve the appearance of the medication.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

13 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

Manufacturer & labeler

LabelerClinical Solutions Wholesale, LLC
Application holderBARR LABORATORIES INC
FDA applicationANDA084769 (ANDA)
Labeler code58118
First marketedDec 2018
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio67 products on file

More NDCs from Clinical Solutions Wholesale, LLC labeler code 58118

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 ⚠️ Precautions 🔒 Drug Abuse and Dependence 📄 Package Label / Principal Display Panel
🚨 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 215 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, and blister cards of 30 (58118-1590-8). 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… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~2 min read ▾

PRECAUTIONS In elderly and debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia or oversedation (10 mg or less per day initially, to be increased gradually as needed and tolerated). In general, the concomitant administration of chlordiazepoxide HCl and other psychotropic agents is not recommended. If such combination therapy seems indicated, careful consideration should be given to the pharmacology of the agents to be employed — particularly when the known potentiating compounds such as MAO inhibitors and phenothiazines are to be used.

The usual precautions in treating patients with impaired renal or hepatic function should be observed. Paradoxical reactions, e.g., excitement, stimulation and acute rage, have been reported in psychiatric patients and in hyperactive aggressive pediatric patients, and should be watched for during chlordiazepoxide HCl therapy. The usual precautions are indicated when chlordiazepoxide HCl is used in the treatment of anxiety states where there is any evidence of impending depression; it should be borne in mind that suicidal tendencies may be present and protective measures may be necessary.

Although clinical studies have not established a cause and effect relationship, physicians should be aware that variable effects on blood coagulation have been reported very rarely in patients receiving oral anticoagulants and chlordiazepoxide HCl. In view of isolated reports associating chlordiazepoxide with exacerbation of porphyria, caution should be exercised in prescribing chlordiazepoxide to patients suffering from this disease. 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). 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.

🔒 Drug Abuse and Dependence 143 words ▾

DRUG ABUSE AND DEPENDENCE Chlordiazepoxide hydrochloride capsules are classified by the Drug Enforcement Administration as a Schedule IV controlled substance. Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of chlordiazepoxide. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time.

Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving chlordiazepoxide or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

📄 Package Label / Principal Display Panel 10 words ▾

Package/Label Display Panel Chlordiazepoxide 25mg Capsules 30 count blister card

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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