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Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg; 2.5 mg Capsule, 100-count — NDC 75826-134-10 (Billing 75826-0134-10)

by Winder Laboratories LLC · 100 CAPSULE in 1 BOTTLE, PLASTIC

This is a package of 100 capsules of Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg; 2.5 mg Capsule from Winder Laboratories LLC, marketed since Dec 2020 and currently FDA-listed. It is this product's only package size.

NDC 75826-0134-10
🏷️ FDA NDC (as labeled) 75826-134-10 billing pads the product 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 75826-134-10
Product NDC 75826-134
11-digit billing NDC 75826013410
RxCUI 889614
UNII MFM6K1XWDK, 91ZQW5JF1Z
UPC 0375826134100
Application # ANDA212344
SPL Set ID 87d1a147-d3c3-4097-aac0-4b19c49eabe3
Established class (EPC) Anticholinergic; Benzodiazepine
Mechanism of action Cholinergic Antagonists
Physiologic effect Decreased Parasympathetic Acetylcholine Activity; Digestive/GI System Activity Alteration; GI Motility Alteration
Chemical class Benzodiazepines
DEA schedule CIV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-12-07
Route ORAL
Dosage form CAPSULE
Substance CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 889614
Why two NDCs? The FDA registers this code as 75826-134-10 — a 5-3-2 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 product segment → 75826-0134-10. 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 Anticholinergic class.

Pharmacologic class Anticholinergic
How it works Cholinergic Antagonists
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

📗 Our plain-language guide HelloPharmacist
  • It's used for stomach and bowel problems that have a stress or emotional component. It can also be added to other treatment for peptic ulcer, irritable bowel syndrome and acute ent...
  • Take it by mouth, usually before meals and at bedtime, exactly as your prescriber directs. Your dose is individualized, so follow your label. Don't stop suddenly if you've been on...
  • Dry mouth, blurry vision, trouble starting urination and constipation are the most typical. Drowsiness, unsteadiness and confusion can also happen, especially in older adults. Call...
  • Avoid alcohol. Opioid pain medicines are a serious concern, since the combination can cause dangerous sleepiness, slowed breathing, coma and death. Tell me or your doctor about eve...
📖 Read our full Chlordiazepoxide and Clidinium 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
75826-0134-10 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE, PLASTIC 2020-12-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 11534-0197-01 Sunrise 100 capsules $0.256 AB Availability likely —
Chlordiazepoxide Hcl And Clidinium Bromide 5 mg/1; 2.5 mg 42571-0381-01 Micro 100 capsules $0.256 AB Availability likely —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 59651-0524-01 Aurobindo 100 capsules $0.256 AB Availability likely —
chlordiazepoxide hydrochloride and clidinium bromide 5 mg/1; 2.5 mg 60219-1677-01 Amneal 100 capsules $0.256 AB Availability likely —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 60687-0639-94 American 20 capsules $0.256 AB Availability likely —
Chlordiazepoxide Hydrochloride And Clidinium Bromide 5 mg/1; 2.5 mg 62135-0696-12 Chartwell 120 capsules $0.256 AB Availability likely —
Chlordiazepoxide hydrochloride and clidinium bromide 5 mg/1; 2.5 mg 62332-0744-31 Alembic 100 capsules $0.256 AB Availability likely —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 67877-0731-01 Ascend 100 capsules $0.256 AB Availability likely —
Librax 5 mg/1; 2.5 mg 00187-4100-10 Bausch 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 00276-0500-10 Misemer 100 capsules — AB FDA listed —
Chlordiazepoxide hydrochloride and clidinium bromide 5 mg/1; 2.5 mg 46708-0744-31 Alembic 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 63629-2373-01 Bryant 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 63629-8859-01 Bryant 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 71335-2966-01 Bryant 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 71335-9764-01 Bryant 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mg 72162-1237-01 Bryant 100 capsules — AB FDA listed —
Chlordiazepoxide Hcl And Clidinium Bromide 5 mg/1; 2.5 mg 72162-2436-01 Bryant 100 capsules — AB FDA listed —
Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/1; 2.5 mgthis 75826-0134-10 Winder 100 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

🏛️
2020
On the market since
Dec 2020
📍
2026
Currently FDA-listed
6 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.

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 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

5 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

LabelerWinder Laboratories LLC
Application holderWINDER LABORATOIRIES LLC
FDA applicationANDA212344 (ANDA)
Labeler code75826
First marketedDec 2020
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio14 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.

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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide ⚠️ Precautions 🔒 Drug Abuse and Dependence 📄 Package Label / Principal Display Panel
🚨 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 in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS and PRECAUTIONS , Drug Interactions ). The use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, 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 and Clidinium Bromide Capsule and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ). The continued use of benzodiazepines, including Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, 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 and Clidinium Bromide Capsule 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 and Clidinium Bromide Capsule or reduce the dosage (see WARNINGS and DOSAGE AND ADMINISTRATION ).

🎯 Indications and Usage 57 words ▾

INDICATIONS AND USAGE: Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.

⏱️ Dosage and Administration 191 words ▾

DOSAGE AND ADMINISTRATION: Recommended Dosage Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 capsules, 3 or 4 times a day administered before meals and at bedtime.

Recommended Geriatric Dosage Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 Chlordiazepoxide Hydrochloride and Clidinium Bromide capsules per day, to be increased gradually as needed and tolerated. Elderly patients have an increased risk of dose-related adverse reactions (See PRECAUTIONS ) Discontinuation or Dosage Reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule or reduce the dosage.

If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS and DRUG ABUSE AND DEPENDENCE ).

⛔ Contraindications 49 words ▾

CONTRAINDICATIONS: Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule is contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to Chlordiazepoxide hydrochloride and/or clidinium bromide.

⚠️ Warnings ~3 min read ▾

WARNINGS: Risks From Concomitant Use with Opioids Concomitant use of benzodiazepines, including Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs - 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 Hydrochloride and Clidinium Bromide Capsule 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. Advise both patients and caregivers about the risks of respiratory depression and sedation when Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule is used with opioids (see PRECAUTIONS ). Abuse, Misuse, and Addiction The use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, 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 ). Before prescribing Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool).

Use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of Librax 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 Hydrochloride and Clidinium Bromide Capsule or reduce the dosage (a patient-specific plan should be used to taper the dosage) (see DOSAGE AND ADMINISTRATION ). 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 Hydrochloride and Clidinium Bromide Capsule, may lead to clinically significant physical dependence.

Abrupt discontinuation or rapid dosage reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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 ) . 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 ).

Effects on the Ability to Drive or Operate Machinery As in the case of other preparations containing CNS-acting drugs, patients receiving Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

ADVERSE REACTIONS: No side effects or manifestations not seen with either compound alone have been reported with the administration of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules. However, since Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule contains chlordiazepoxide hydrochloride and clidinium bromide, the possibility of untoward effects which may be seen with either of these two compounds cannot be excluded. When chlordiazepoxide hydrochloride has been used alone 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 with chlordiazepoxide hydrochloride 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 hydrochloride treatment.

Blood dyscrasias, including agranulocytosis, jaundice and hepatic dysfunction have occasionally been reported during therapy with chlordiazepoxide hydrochloride. When chlordiazepoxide hydrochloride treatment is protracted, periodic blood counts and liver function tests are advisable. Adverse effects reported with use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules are those typical of anticholinergic agents, i.e., dryness of the mouth, blurring of vision, urinary hesitancy and constipation.

Constipation has occurred most often when Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule therapy has been combined with other spasmolytic agents and/or a low residue diet. To report SUSPECTED ADVERSE REACTIONS, contact Winder Laboratories LLC at 1-770-307-0703 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 141 words ▾

Drug Interactions Opioids The concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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 Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule and opioids, and follow patients closely for respiratory depression and sedation. Oral Anticoagulants 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 hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule.

🤰 Pregnancy 119 words ▾

Usage in Pregnancy An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.

Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug. As with all anticholinergic drugs, an inhibiting effect on lactation may occur (see ANIMAL PHARMACOLOGY ).

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 94 words ▾

Geriatric Use Geriatric subjects may be particularly prone to experiencing drowsiness, ataxia and confusion while receiving Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule. These effects can usually be avoided with proper dosage adjustment, although they have occasionally been observed even at the lower dosage ranges. Dosing in geriatric subjects should be initiated cautiously (no more than 2 capsules per day) and increased gradually if needed and tolerated (see DOSAGE AND ADMINISTRATION ).

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule is contraindicated in the presence of glaucoma, prostatic hypertrophy and benign bladder neck obstruction (see CONTRAINDICATIONS ).

🆘 Overdosage ~1 min read ▾

OVERDOSAGE: Manifestations of chlordiazepoxide hydrochloride overdosage include 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 hydrochloride overdosage. While the signs and symptoms of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule overdosage may be produced by either of its components, usually such symptoms will be overshadowed by the anticholinergic actions of clidinium bromide.

The symptoms of overdosage of clidinium bromide are excessive dryness of mouth, blurring of vision, urinary hesitancy and constipation. General supportive measures should be employed, along with immediate gastric lavage. Administer physostigmine 0.5 to 2 mg at a rate of no more than 1 mg per minute.

This may be repeated in 1 to 4 mg doses if arrhythmias, convulsions or deep coma recur. Intravenous fluids should be administered and an adequate airway maintained. Hypotension may be combated by the use of levarterenol or metaraminol.

Methylphenidate or caffeine and sodium benzoate may be given to combat CNS-depressive effects. Dialysis is of limited value. Should excitation occur, 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. Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (see DRUG ABUSE AND DEPENDENCE ).

📦 How Supplied / Storage and Handling 81 words ▾

HOW SUPPLIED: Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule is available in light green opaque capsules, each containing 5 mg Chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide — bottles of 100 (NDC 75826-134-10), with "WL" and "134" imprinted on the body of the capsule. Storage: Store at 20º to 25°C (68º to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep out of reach of children.

Dispense in tight, light-resistant container as defined in USP/NF.

📋 Description 161 words ▾

DESCRIPTION Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules is a fixed-combination of chlordiazepoxide hydrochloride, a benzodiazepine, and clidinium bromide, an anticholinergic. Each Chlordiazepoxide Hydrochloride and Clidinium Bromide capsule contains the active ingredients 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Each capsule also contains the inactive ingredients lactose monohydrate, pregelatinized starch, talc, ammonia solution, FC&C blue #1, FC&C red #40, FC&C yellow #6, propylene glycol, shellac, titanium dioxide, and gelatin.

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

The molecular weight is 336.22. The structural formula of chlordiazepoxide hydrochloride is as follows: Clidinium bromide is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a antispasmodic and antisecretory effects on the gastrointestinal tract. Structurally clidinium bromide is: FDA approved dissolution specification differs from the USP dissolution specification.

Chemical Structure Chemical Structure

💬 Information for Patients ~1 min read ▾

Information for Patients Abuse, Misuse, and Addiction Inform patients that the use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances . Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug (see WARNINGS ) .

Withdrawal Reactions Inform patients that the continued use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months.

Instruct patients that discontinuation or dosage reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule may require a slow taper (see WARNINGS and DRUG ABUSE AND DEPENDENCE ) . Concomitant Use With Opioids and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule is used with opioids or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider (see WARNINGS and PRECAUTIONS , Drug Interactions ).

💬 Medication Guide ~2 min read ▾

Medication Guide Chlordiazepoxide Hydrochloride (KLOR-dye-AZ-e-POX-ide hahy-druh-klawr-ahyd) and Clidinium Bromide (kli-DIN-ee-um bro-mide) Capsules for oral use What is the most important information I should know about Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule? Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule contains a benzodiazepine medicine. Taking Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.

Get emergency help right away if any of the following happens: shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, which can lead to overdose or death.

Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.

You can develop an addiction even if you take Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule as prescribed by your healthcare provider. Take Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule exactly as your healthcare provider prescribed. Do not share your Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule with other people.

Keep Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule in a safe place and away from children. Physical dependence and withdrawal reactions. Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule can cause physical dependence and withdrawal reactions.

Do not suddenly stop using Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule . Stopping Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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 twitches, 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 Hydrochloride and Clidinium Bromide Capsule than prescribed or take Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule for longer than prescribed. What is Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule? Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule is a prescription medicine that is used with other therapies for the treatment of: stomach (peptic) ulcers irritable bowel syndrome (IBS) inflammation of the colon called acute enterocolitis Chlordiazepoxide Hy… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~3 min read ▾

PRECAUTIONS: CNS Adverse Reactions In geriatric or debilitated patients, it is recommended that the dosage be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion (not more than 2 Chlordiazepoxide Hydrochloride and Clidinium Bromide capsules per day initially, to be increased gradually as needed and tolerated). In general, the concomitant administration of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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 the 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 to chlordiazepoxide hydrochloride, e.g., excitement, stimulation and acute rage, have been reported in psychiatric patients and should be watched for during Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule therapy.

The usual precautions are indicated when chlordiazepoxide hydrochloride 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. Information for Patients Abuse, Misuse, and Addiction Inform patients that the use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances .

Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug (see WARNINGS ) . Withdrawal Reactions Inform patients that the continued use of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule may precipitate acute withdrawal reactions, which can be life-threatening.

Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule may require a slow taper (see WARNINGS and DRUG ABUSE AND DEPENDENCE ) . Concomitant Use With Opioids and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule is used with opioids or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider (see WARNINGS and PRECAUTIONS , Drug Interactions ).

Drug Interactions Opioids The concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule 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 Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule and opioids, and follow patients closely for respiratory depression and sedation. Oral Anticoagulants Although clinical studies have not established a cause and effe… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence ~2 min read ▾

DRUG ABUSE AND DEPENDENCE Controlled Substance Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules contains chlordiazepoxide hydrochloride, a Schedule IV controlled substance and clidinium bromide, which is not a controlled substance. Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules is exempted from Schedule IV and is not controlled under the Controlled Substances Act. Abuse Chlordiazepoxide hydrochloride, a component of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, is a CNS depressant with a potential for abuse and addiction.

Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.

Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction. 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.

Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see WARNINGS ). The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death.

Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol). Dependence Physical Dependence Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.

Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see WARNINGS ). To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsule or reduce the dosage (see WARNINGS and DOSAGE AND ADMININSTRATION ).

Acute Withdrawal Signs and Symptoms Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decre… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 41 words ▾

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label NDC 75826-134-10 Rx Only Chlordiazepoxide HCl and Clidinium Bromide Capsules, USP 5 mg/2.5 mg * Dispense the Medication Guide provided separately to each patient 100 Capsules PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle

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

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 and Clidinium Bromide — the ingredient across all brands.

Top reported reactions

Diarrhoea182
Nausea182
Fatigue167
Pain132
Headache120
Abdominal Pain112
Dizziness108

Age at onset

Adolescent3
Adult89
Elderly82

Reporter sex

1,919 reports
Male · 19%
Female · 81%
Unknown · 0%

Serious outcomes

Hospitalization526
Death68
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 60 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.

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) ✓ 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Winder Laboratories LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Winder Laboratories 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.
← 75826-0131-01 · Winder 75826-0136-10 · WINDER →
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.