Chlordiazepoxide Hydrochloride 10 mg Capsule, 1,000-count — NDC 00555-0033-05 package photo

Chlordiazepoxide Hydrochloride 10 mg Capsule, 1,000-count

by Teva Pharmaceuticals USA, Inc. · 1000 CAPSULE in 1 BOTTLE (0555-0033-05)
NDC 00555-0033-05
🏷️ FDA NDC (as labeled) 0555-0033-05 billing pads the labeler segment with a zero
This package
Contains1,000-count Cost per ea$0.1432 NADAC Per package$143.20 / 1000 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2829/unit · Part D plans $0.2924/unit — full pricing hub ↓
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 →

🆔 Identity & classification

FDA NDC (as labeled) 0555-0033-05
Product NDC 0555-0033
11-digit billing NDC 00555003305
NCPDP billing unit EA — each (per item)
RxCUI 905369, 905495, 905516
UNII MFM6K1XWDK
Application # ANDA083116
SPL Set ID e3ff8641-ae8a-4016-acb1-cb1b7890f5ed
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 1990-09-30
Route ORAL
Dosage form CAPSULE
Substance CHLORDIAZEPOXIDE HYDROCHLORIDE
GPI-14 57100020100110
GPI class chlordiazePOXIDE HCl
GCN Seq No 003734
GCN 14031
HICL code 001610
Ingredient (HICL) Chlordiazepoxide Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H20
Therapeutic class — specific (HIC3) Anti-Anxiety - Benzodiazepines
AHFS code 28:24.08.00
AHFS class Benzodiazepines (Anxiolytic,Sedativ/Hyp)
FDB label name CHLORDIAZEPOXIDE 10 MG CAPSULE
FDB brand name Chlordiazepoxide Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0555-0033-05 — a 4-4-2 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 labeler segment → 00555-0033-05. 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

LabelerTeva Pharmaceuticals USA, Inc.
Application holderBARR LABORATORIES INC
FDA applicationANDA083116 (ANDA)
Labeler code00555
First marketedSep 1990
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio504 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

Label name CHLORDIAZEPOXIDE 10 MG CAPSULE Ingredient Chlordiazepoxide Hcl
📗 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 →
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.

💊 What it looks like

Color green / yellow / black / 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 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 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 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

12 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 DailyMedingredient 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.

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.143 $143.20 / 1000 capsules
Medicaid paysCMS SDUD · 12 mo $0.2829 $282.90 / 1000 capsules
Medicare drug plans payPart D · Q2 2026 $0.2924 $292.40 / 1000 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Oct 2022 Feb 2026 Aug 2026 $0.143 $0.080
▲ Up 78% over the last 19 months.
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 mgthis 00555-0033-05 Teva 1000 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 mg 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

🏛️
1990
On the market since
Sep 1990
📍
2026
Currently FDA-listed
36 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00555-0033-05, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.1K
Units reimbursed last 4 qtrs
63.5K
Gross reimbursed last 4 qtrs
$18K
Avg / prescription
$8.68
Avg / unit
$0.2829
Latest quarter Q4 2025
366Rx
Medicaid pays / ea
$0.2829
gross reimbursed
vs
NADAC / ea
$0.1432
acquisition cost
=
Spread
+$0.1397
+98% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
30% FFS 70% MCO
Fee-for-service · 617 Rx Managed care · 1,453 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 10,643 units · 54.4 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 198 units · 2.9 per 100k residents IN Ohio: 1,357 units · 11.5 per 100k residents OH Pennsylvania: 3,260 units · 25.2 per 100k residents PA New Jersey: 10,541 units · 113 per 100k residents NJ Massachusetts: no data reported MA California: 1,880 units · 4.8 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 347 units · 17.5 per 100k residents NE Missouri: 1,500 units · 24.2 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 965 units · 15.6 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 203 units · 2.8 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 32,650 units · 144 per 100k residents FL
Units reimbursed · per 100k residents
2.8144
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Florida 144 /100k
2 New Jersey 113 /100k
3 New York 54.4 /100k
4 Pennsylvania 25.2 /100k
5 Missouri 24.2 /100k
6 Nebraska 17.5 /100k
7 Maryland 15.6 /100k
8 Ohio 11.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 capsules00555-0033-02 15,365 Rx · $157,503
Drug total (last 4 qtrs): 17,435 Rx · 530,388 units · $175,481 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 Per unit Per pack Marketing startStatus
00555-0033-02 100 CAPSULE in 1 BOTTLE (0555-0033-02) $0.1432 / ea $14.32 1990-09-30 Active
00555-0033-05 You're viewing this 1000 CAPSULE in 1 BOTTLE (0555-0033-05) $0.1432 / ea $143.19 1990-09-30 Active

You're viewing the largest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.1432 NADAC).

This pack accounts for about 12% of this product's recent Medicaid fills; most go to the 100 capsules pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 00555-0033-05?
NDC 00555-0033-05 is a 1,000-count package — 1000 capsule in 1 bottle.
What is the difference between NDC 00555-0033-05 and NDC 00555-0033-02?
Both are Chlordiazepoxide Hydrochloride 10 mg Capsule — the drug itself is identical. NDC 00555-0033-05 is the 1,000-count package, while NDC 00555-0033-02 is the 100 capsules package.
What NDC number is used to bill for this package of Chlordiazepoxide Hydrochloride 10 mg Capsule?
Bill NDC 00555-0033-05 — the 11-digit billing format is 00555003305. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 ~1 min read

WARNING: 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 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 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 risks of dependence and withdrawal increase with longer treatment duration and higher daily dose.

Abrupt discontinuation or rapid dosage reduction of chlordiazepoxide hydrochloride capsules after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide hydrochloride capsules or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS ).

🎯 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 ~2 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. *See package insert for Sterile Chlordiazepoxide Hydrochloride. Discontinuation or Dosage Reduction of Chlordiazepoxide To reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increase the dosage to the previous tapered dosage level.

Subsequently decrease the dosage more slowly (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE: Dependence ).

Contraindications 14 words

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

⚠️ Warnings ~3 min read

WARNINGS Risks from Concomitant Use with Opioids 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 ). Abuse, Misuse, and Addiction The use of benzodiazepines, including chlordiazepoxide, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death.

Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death (see DRUG ABUSE AND DEPENDENCE: Abuse ) . Before prescribing chlordiazepoxide and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool).

Use of chlordiazepoxide, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of chlordiazepoxide along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.

Dependence and Withdrawal Reactions To reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide or reduce the dosage (a patient-specific plan should be used to taper the dose) (see DOSAGE AND ADMINISTRATION: Discontinuation or Dosage Reduction of chlordiazepoxide ). Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. Acute Withdrawal Reactions The continued use of benzodiazepines, including chlordiazepoxide, may lead to clinically significant physical dependence.

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: Dependence ) . Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see DRUG ABUSE AND DEPENDENCE: Dependence ). Chlordiazepoxide HCl may impair the mental and/or physical…

🤒 Adverse Reactions 171 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.

To report SUSPECTED ADVERSE EVENTS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.

🧒 Pediatric Use 70 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 ).

🧬 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 a 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 offspring 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 200 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. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. O 6/2025

📋 Description 216 words

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

Chlordiazepoxide hydrochloride, USP 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, 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.

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

In addition, the 5 mg contains D&C red no. 33 and the 10 mg also contains FD&C red no. 40, povidone, propylene glycol, and sodium hydroxide.

The 5 mg and 25 mg may also contain propylene glycol. Chlordiazepoxide hydrochloride structural formula

💬 Information for Patients 14 words

Information for Patients Advise the patient to read the FDA-approved patient labeling (Medication Guide).

💬 Medication Guide ~3 min read

MEDICATION GUIDE Chlordiazepoxide Hydrochloride ( klorʺ dye azʺ e poxʹ ide hyeʺ droe klorʹ ide ) Capsules, C-IV What is the most important information I should know about Chlordiazepoxide HCl ? Chlordiazepoxide HCl 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 HCl with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including Chlordiazepoxide HCl, 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 HCl. 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 HCl exactly as prescribed by your healthcare provider. Take Chlordiazepoxide HCl exactly as your healthcare provider prescribed. Do not share your Chlordiazepoxide HCl with other people.

Keep Chlordiazepoxide HCl in a safe place and away from children. Physical dependence and withdrawal reactions . Chlordiazepoxide HCl can cause physical dependence and withdrawal reactions, especially if you continue to take Chlordiazepoxide HCl for several days to several weeks.

Do not suddenly stop taking Chlordiazepoxide HCl . Stopping Chlordiazepoxide HCl suddenly can cause serious and life-threatening side effects, including unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.

Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months , including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears. Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.

Do not take more Chlordiazepoxide HCl than prescribed or take Chlordiazepoxide HCl for longer than prescribed. What is Chlordiazepoxide HCl ? Chlordiazepoxide HCl 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 HCl is a federal controlled substance (C-IV) because it contains chlordiazepoxide that can be abused or lead to dependence.

Keep Chlordiazepoxide HCl in a safe place to prevent misuse and abuse. Selling or giving away Chlordiazepoxide HCl 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 HCl is safe and effective in children under 6 years of age. It is not known if Chlordiazepoxide HCl is safe and effective for use for longer tha…

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