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Loperamide Hydrochloride 2 mg Capsule, 15-count — NDC 66267-0132-15 package photo

Loperamide Hydrochloride 2 mg Capsule, 15-count

by NuCare Pharmaceuticals, Inc. · 15 CAPSULE in 1 BOTTLE (66267-132-15)
NDC 66267-0132-15
🏷️ FDA NDC (as labeled) 66267-132-15 billing pads the product segment with a zero
This package
Contains15-count Pack sizes5 compare ↓
Also priced by: Part D plans $0.2376/unit — full pricing hub ↓
Also comes in: 12 capsules 66267-0132-12 15 capsules 66267-0132-60 18 capsules 66267-0132-18 20 capsules 66267-0132-20
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 66267-132-15
Product NDC 66267-132
11-digit billing NDC 66267013215
RxCUI 978006
UNII 77TI35393C
UPC 0366267132152
Application # ANDA073192
SPL Set ID 3e898141-8d40-49f1-e054-00144ff88e88
Established class (EPC) Opioid Agonist
Mechanism of action Opioid Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1993-05-01
Route ORAL
Dosage form CAPSULE
Substance LOPERAMIDE HYDROCHLORIDE
GPI-14 47100020100105
GPI class Loperamide HCl
GCN Seq No 002842
GCN 08370
HICL code 001236
Ingredient (HICL) Loperamide Hcl
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6D
Therapeutic class — specific (HIC3) Antidiarrheals
AHFS code 56:08.00.00
AHFS class Antidiarrhea Agents
FDB label name LOPERAMIDE 2 MG CAPSULE
FDB brand name Loperamide
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 66267-132-15 — 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 → 66267-0132-15. 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 Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Antipropulsives
How it works Opioid Agonists
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

LabelerNuCare Pharmaceuticals, Inc.
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA073192 (ANDA)
Labeler code66267
First marketedMay 1993
Product typeHuman Prescription Drug
Portfolio362 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 LOPERAMIDE 2 MG CAPSULE Ingredient Loperamide Hcl
📗 Our plain-language guide HelloPharmacist
  • Loperamide works by binding to the same type of receptors in your gut that opioids do, but it stays mostly in the intestines and very little gets into your bloodstream at the recom...
  • What exactly does loperamide do — and is it like taking an opioid?
  • For acute diarrhea, stop and call your doctor if symptoms don't improve within 2 days, or if they get worse. You should also stop right away if you develop bloating or a swollen be...
  • How long can I take loperamide before I should see a doctor?
📖 Read our full Loperamide 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.

💊 What it looks like

Color brown
ShapeCapsule
ImprintTEVA;0311
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 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • 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 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 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • 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 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 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.

10 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.

💲 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 $0.2376 $3.56 / 15 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Loperamide Hydrochloride 2 mg 00093-0311-01 Teva 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 00378-2100-01 Mylan 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 00904-7472-61 Major 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 42799-0605-01 Edenbridge 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 50268-0482-15 AvPAK 50 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 51079-0690-20 Mylan 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 59651-0691-01 Aurobindo 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 60687-0229-01 American 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 69452-0271-20 Bionpharma 100 capsules $0.056 AB Availability likely —
Loperamide hydrochloride 2 mg 72578-0138-01 Viona 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 72603-0328-01 NorthStar 100 capsules $0.056 AB Availability likely —
Anti-Diarrheal 2 mg 46122-0581-62 AMERISOURCE 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 70000-0461-01 CARDINAL 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 70677-1062-01 STRATEGIC 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 83324-0208-12 CHAIN 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 83324-0209-24 CHAIN 12 capsules $0.136 — Availability likely —
Anti-Diarrheal 2 mg 63868-0876-12 CHAIN 12 capsules $0.140 — FDA listed —
Anti-Diarrheal 2 mg 62011-0390-01 Strategic 12 capsules $0.150 — FDA listed —
Anti-Diarrheal 2 mg 00363-1176-08 WALGREENS 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 00615-8497-39 NCS 30 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 11673-0177-12 TARGET 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 11822-7834-02 Rite 12 capsules — — FDA listed —
anti-diarrheal 2 mg 21130-0835-12 Albertsons 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 30142-0159-08 KROGER 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 36800-0208-12 TOP 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 37808-0988-12 HEB 12 capsules — — FDA listed —
anti-diarrheal 2 mg 41250-0210-08 MEIJER 12 capsules — — FDA listed —
First Aid Direct Anti-Diarrheal 2 mg 42961-0103-02 Cintas 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 43063-0020-12 PD-Rx 12 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 43598-0770-24 Dr. 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 48433-0063-20 Safecor 100 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 49035-0483-12 Wal-Mart 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 50090-0460-00 A-S 15 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 50090-7398-00 A-S 15 capsules — AB FDA listed —
Imodium A-D 2 mg 50580-0367-01 Kenvue 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 51407-0999-01 Golden 100 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 53943-0176-12 DISCOUNT 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 55154-4699-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 55154-5585-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 55289-0315-06 PD-Rx 6 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 55910-0176-08 DOLGENCORP, 12 capsules — — FDA listed —
anti-diarrheal 2 mg 56062-0680-12 PUBLIX 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 58602-0727-74 Aurohealth 6 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 60468-0005-01 allphamed 100 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 63629-8747-01 Bryant 100 capsules — AB FDA listed —
anti-diarrheal 2 mg 63941-0684-12 VALU 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mgthis 66267-0132-15 NuCare 15 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 67046-1676-03 Coupler 30 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 67296-2172-01 Redpharm 15 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 68016-0058-12 Premier 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 68071-2257-06 NuCare 6 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 68071-2700-01 NuCare 12 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 68071-3618-01 NuCare 12 capsules — AB FDA listed —
anti-diarrheal 2 mg 69452-0176-12 Bionpharma 24 capsules — — FDA listed —
anti-diarrheal 2 mg 69452-0266-12 Bionpharma 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 69842-0061-12 CVS 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 70518-4283-00 REMEDYREPACK 30 capsules — AB FDA listed —
Loperamide hydrochloride 2 mg 70771-1769-01 Zydus 100 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-1921-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2061-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2111-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2487-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2571-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0648-53 Aphena 60 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0781-53 Aphena 60 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0950-30 Aphena 30 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0973-53 Aphena 60 capsules — AB FDA listed —
anti-diarrheal 2 mg 72288-0313-12 Amazon.com 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 72888-0130-00 Advagen 1000 capsules — AB FDA listed —
WELMATE Anti Diarrheal Loperamide HCl Softgels 2 mg 73581-0102-24 YYBA 24 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 75907-0097-12 Dr. 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 80136-0851-42 Northeast 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 55154-0277-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 59556-0959-05 Strides 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 73581-0177-02 YYBA 12 capsules — — 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

🏛️
1993
On the market since
May 1993
📍
2026
Currently FDA-listed
33 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Diarrhoea9,086
Nausea4,381
Fatigue3,945
Vomiting2,858
Constipation2,668
Weight Decreased2,118
Headache2,063

Age at onset

Neonate13
Infant24
Child103
Adolescent111
Adult5,069
Elderly7,388

Reporter sex

50,042 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization16,195
Death3,923
Life-threatening1,723
Disabling651
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,121 1,802
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
66267-0132-12 12 CAPSULE in 1 BOTTLE (66267-132-12) 2016-10-10 Active
66267-0132-15 You're viewing this 15 CAPSULE in 1 BOTTLE (66267-132-15) 2016-10-10 Active
66267-0132-18 18 CAPSULE in 1 BOTTLE (66267-132-18) 2016-10-10 Active
66267-0132-20 20 CAPSULE in 1 BOTTLE (66267-132-20) 2016-10-10 Active
66267-0132-60 15 CAPSULE in 1 BOTTLE (66267-132-60) 2017-12-28 Active

Pack size FAQ

What quantity is in NDC 66267-0132-15?
NDC 66267-0132-15 is a 15-count package — 15 capsule in 1 bottle.
What is the difference between NDC 66267-0132-15 and NDC 66267-0132-12?
Both are Loperamide Hydrochloride 2 mg Capsule — the drug itself is identical. NDC 66267-0132-15 is the 15-count package, while NDC 66267-0132-12 is the 12 capsules package.
What NDC number is used to bill for this package of Loperamide Hydrochloride 2 mg Capsule?
Bill NDC 66267-0132-15 — the 11-digit billing format is 66267013215. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ Available
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 FDA registers it as 66267-132-15, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 66267-0132-15, written without dashes as 66267013215. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 66267-0132-15, the first segment (66267) is the labeler code FDA assigned to NuCare Pharmaceuticals, Inc.; the middle segment (0132) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by NuCare Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 12 capsules (66267-0132-12), 15 capsules (66267-0132-60), 18 capsules (66267-0132-18). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
NuCare Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 41 words ▾

INDICATIONS AND USAGE Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION (1 capsule = 2 mg) Patients should receive appropriate fluid and electrolyte replacement as needed. Acute Diarrhea Adults The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. Daily dosage should not exceed 16 mg (eight capsules).

Clinical improvement is usually observed within 48 hours. Children In children 2 to 5 years of age (20 kg or less), the non-prescription liquid formulation (loperamide hydrochloride for oral solution, 1 mg/5 mL) should be used; for ages 6 to 12, either loperamide hydrochloride capsules or loperamide hydrochloride for oral solution may be used. For children 2 to 12 years of age, the following schedule for capsules or liquid will usually fulfill initial dosage requirements: Recommended First Day Dosage Schedule Two to five years: 1 mg t.i.d.

(3 mg daily dose) (13 to 20 kg) Six to eight years: 2 mg b.i.d. (4 mg daily dose) (20 to 30 kg) Eight to twelve years: 2 mg t.i.d. (6 mg daily dose) (greater than 30 kg) Recommended Subsequent Daily Dosage Following the first treatment day, it is recommended that subsequent loperamide hydrochloride doses (1 mg/10 kg body weight) be administered only after a loose stool.

Total daily dosage should not exceed recommended dosages for the first day. Chronic Diarrhea Children Although loperamide hydrochloride has been studied in a limited number of children with chronic diarrhea; the therapeutic dose for the treatment of chronic diarrhea in a pediatric population has not been established. Adults The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool until diarrhea is controlled, after which the dosage of loperamide hydrochloride capsules should be reduced to meet individual requirements.

When the optimal daily dosage has been established, this amount may then be administered as a single dose or in divided doses. The average daily maintenance dosage in clinical trials was 4 to 8 mg (two to four capsules). A dosage of 16 mg (eight capsules) was rarely exceeded.

If clinical improvement is not observed after treatment with 16 mg per day for at least 10 days, symptoms are unlikely to be controlled by further administration. Loperamide hydrochloride capsules administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment. Children Under 2 Years The use of loperamide hydrochloride in children under 2 years is not recommended.

There have been rare reports of paralytic ileus associated with abdominal distention. Most of these reports occurred in the setting of acute dysentery, overdose, and with very young children less than two years of age. Elderly No formal pharmacokinetic studies were conducted in elderly subjects.

However, there were no major differences reported in the drug disposition in elderly patients with diarrhea relative to young patients. No dosage adjustment is required for the elderly. Renal Impairment No pharmacokinetic data are available in patients with renal impairment.

Since the metabolites and the unchanged drug are mainly excreted in the feces, no dosage adjustment is required for patients with renal impairment (see PRECAUTIONS ). Hepatic Impairment Although no pharmacokinetic data are available in patients with hepatic impairment, loperamide hydrochloride should be used with caution in such patients because of reduced first pass metabolism (see PRECAUTIONS ).

⛔ Contraindications 104 words ▾

CONTRAINDICATIONS Loperamide hydrochloride capsules are contraindicated in patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. Loperamide hydrochloride is contraindicated in patients with abdominal pain in the absence of diarrhea. Loperamide hydrochloride is not recommended in infants below 24 months of age.

Loperamide hydrochloride should not be used as the primary therapy: in patients with acute dysentery, which is characterized by blood in stools and high fever, in patients with acute ulcerative colitis, in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella, and Campylobacter, in patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics.

⚠️ Warnings 194 words ▾

WARNINGS Fluid and electrolyte depletion often occur in patients who have diarrhea. In such cases, administration of appropriate fluid and electrolytes is very important. The use of loperamide hydrochloride does not preclude the need for appropriate fluid and electrolyte therapy.

In general, loperamide hydrochloride should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. Loperamide hydrochloride must be discontinued promptly when constipation, abdominal distention or ileus develop. Treatment of diarrhea with loperamide hydrochloride is only symptomatic.

Whenever an underlying etiology can be determined, specific treatment should be given when appropriate (or when indicated). Patients with AIDS treated with loperamide hydrochloride for diarrhea should have therapy stopped at the earliest signs of abdominal distention. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride. {ref EDMS-PSDB-2564186, p.

12} Loperamide hydrochloride should be used with special caution in young children because of the greater variability of response in this age group. Dehydration, particularly in younger children, may further influence the variability of response to loperamide hydrochloride.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Clinical Trial Data The adverse effects reported during clinical investigations of loperamide hydrochloride are difficult to distinguish from symptoms associated with the diarrheal syndrome. Adverse experiences recorded during clinical studies with loperamide hydrochloride were generally of a minor and self-limiting nature. They were more commonly observed during the treatment of chronic diarrhea.

The adverse events reported are summarized irrespective of the causality assessment of the investigators. 1) Adverse events from 4 placebo-controlled studies in patients with acute diarrhea The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented in the table below. Acute Diarrhea Loperamide Hydrochloride Placebo No. of treated patients 231 236 Gastrointestinal AE% Constipation 2.6% 0.8% The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride were: dry mouth, flatulence, abdominal cramp and colic.

2) Adverse events from 20 placebo-controlled studies in patients with chronic diarrhea The adverse events with an incidence of 1.0% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented below in the table below. Chronic Diarrhea Loperamide Hydrochloride Placebo No. of treated patients 285 277 Gastrointestinal AE% Constipation 5.3% 0% Central and peripheral nervous system AE% Dizziness 1.4% 0.7% The adverse events with an incidence of 1.0% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride were: nausea, vomiting, headache, meteorism, abdominal pain, abdominal cramp and colic.

3) Adverse events from seventy-six controlled and uncontrolled studies in patients with acute or chronic diarrhea The adverse events with an incidence of 1.0% or greater in patients from all studies are given in the table below. Acute Diarrhea Chronic Diarrhea All Studies All patients in all studies, including those in which it was not specified if the adverse events occurred in patients with acute or chronic diarrhea. No. of treated patients 1913 1371 3740 Gastrointestinal AE% Nausea 0.7% 3.2% 1.8% Constipation 1.6% 1.9% 1.7% Abdominal cramps 0.5% 3.0% 1.4% Postmarketing Experience The following adverse events have been reported: Skin and Subcutaneous Tissue Disorders Rash, pruritus, urticaria, angioedema, and extremely rare cases of bullous eruption including erythema multiforme, Stevens-Johnson syndrome and Toxic Epidermal Necrolysis have been reported with use of loperamide hydrochloride.

Immune System Disorders Isolated occurrences of allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions have been reported with the use of loperamide hydrochloride. Gastrointestinal Disorders Dry mouth, abdominal pain, distention or discomfort, nausea, vomiting, flatulence, dyspepsia, constipation, paralytic ileus, megacolon, including toxic megacolon (see CONTRAINDICATIONS and WARNINGS ). Renal and Urinary Disorders Urinary retention.

Nervous System Disorders Drowsiness, dizziness. General Disorders and Administrative Site Conditions Tiredness. A number of the adverse events reported during the clinical investigations and postmarketing experience with loperamide are frequent symptoms of the underlying diarrheal syndrome (abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence).

These symptoms are often difficult to distinguish from undesirable drug effects.

🔄 Drug Interactions 155 words ▾

Drug Interactions Nonclinical data have shown that loperamide is a P-glycoprotein substrate. Concomitant administration of loperamide (16 mg single dose) with a 600 mg single dose of either quinidine or ritonavir, both of which are P-glycoprotein inhibitors, resulted in a 2 to 3 fold increase in loperamide plasma levels. Due to the potential for enhanced central effects when loperamide is coadministered with quinidine and with ritonavir, caution should be exercised when loperamide is administered at the recommended dosages (2 mg, up to 16 mg maximum daily dose) with P-glycoprotein inhibitors.

When a single 16 mg dose of loperamide is coadministered with a 600 mg single dose of saquinavir, loperamide decreased saquinavir exposure by 54%, which may be of clinical relevance due to reduction of therapeutic efficacy of saquinavir. The effect of saquinavir on loperamide is of less clinical significance. Therefore, when loperamide is given with saquinavir, the therapeutic efficacy of saquinavir should be closely monitored.

🤰 Pregnancy 167 words ▾

Pregnancy Teratogenic Effects Pregnancy category C Teratology studies have been performed in rats using oral doses of 2.5, 10, and 40 mg/kg/day, and in rabbits using oral doses of 5, 20, and 40 mg/kg/day. These studies have revealed no evidence of impaired fertility or harm to the fetus at doses up to 10 mg/kg/day in rats (5 times the human dose based on body surface area comparison) and 40 mg/kg/day in rabbits (43 times the human dose based on body surface area comparison). Treatment of rats with 40 mg/kg/day p.o.

(21 times the human dose based on a body surface area comparison) produced marked impairment of fertility. The studies produced no evidence of teratogenic activity. There are no adequate and well-controlled studies in pregnant women.

Loperamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Non-teratogenic Effects In a peri- and post-natal reproduction study in rats, oral administration of 40 mg/kg/day produced impairment of growth and survival of offspring.

🧒 Pediatric Use 35 words ▾

Pediatric Use See the WARNINGS section for information on the greater variability of response in this age group. In case of accidental overdosage of loperamide hydrochloride by pediatric patients, see OVERDOSAGE section for suggested treatment.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE In cases of overdosage, (including relative overdose due to hepatic dysfunction), urinary retention, paralytic ileus and CNS depression may occur. Children may be more sensitive to CNS effects than adults. Clinical trials have demonstrated that a slurry of activated charcoal administered promptly after ingestion of loperamide hydrochloride can reduce the amount of drug which is absorbed into the systemic circulation by as much as ninefold.

If vomiting occurs spontaneously upon ingestion, a slurry of 100 grams of activated charcoal should be administered orally as soon as fluids can be retained. If vomiting has not occurred, gastric lavage should be performed followed by administration of 100 grams of the activated charcoal slurry through the gastric tube. In the event of overdosage, patients should be monitored for signs of CNS depression for at least 24 hours.

If symptoms of overdose occur, naloxone can be given as an antidote. If responsive to naloxone, vital signs must be monitored carefully for recurrence of symptoms of drug overdose for at least 24 hours after the last dose of naloxone. In view of the prolonged action of loperamide and the short duration (one to three hours) of naloxone, the patient must be monitored closely and treated repeatedly with naloxone as indicated.

Since relatively little drug is excreted in the urine, forced diuresis is not expected to be effective for loperamide hydrochloride overdosage. In clinical trials an adult who took three 20 mg doses within a 24 hour period was nauseated after the second dose and vomited after the third dose. In studies designed to examine the potential for side effects, intentional ingestion of up to 60 mg of loperamide hydrochloride in a single dose to healthy subjects resulted in no significant adverse effects.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY In vitro and animal studies show that loperamide hydrochloride acts by slowing intestinal motility and by affecting water and electrolyte movement through the bowel. Loperamide binds to the opiate receptor in the gut wall. Consequently, it inhibits the release of acetylcholine and prostaglandins, thereby reducing peristalsis, and increasing intestinal transit time.

Loperamide increases the tone of the anal sphincter, thereby reducing incontinence and urgency. In man, loperamide hydrochloride prolongs the transit time of the intestinal contents. It reduces the daily fecal volume, increases the viscosity and bulk density, and diminishes the loss of fluid and electrolytes.

Tolerance to the antidiarrheal effect has not been observed. Clinical studies have indicated that the apparent elimination half-life of loperamide hydrochloride in man is 10.8 hours with a range of 9.1 to 14.4 hours. Plasma levels of unchanged drug remain below 2 nanograms per mL after the intake of a 2 mg loperamide hydrochloride capsule.

Plasma levels are highest approximately five hours after administration of the capsule and 2.5 hours after the liquid. The peak plasma levels of loperamide were similar for both formulations. Elimination of loperamide mainly occurs by oxidative N-demethylation.

Cytochrome P450 (CYP450) isozymes, CYP2C8 and CYP3A4, are thought to play an important role in loperamide N-demethylation process since quercetin (CYP2C8 inhibitor) and ketoconazole (CYP3A4 inhibitor) significantly inhibited the N-demethylation process in vitro by 40% and 90%, respectively. In addition, CYP2B6 and CYP2D6 appear to play a minor role in loperamide N-demethylation. Excretion of the unchanged loperamide and its metabolites mainly occurs through the feces.

In those patients in whom biochemical and hematological parameters were monitored during clinical trials, no trends toward abnormality during loperamide hydrochloride therapy were noted. Similarly, urinalyses, EKG and clinical ophthalmological examinations did not show trends toward abnormality.

📦 How Supplied / Storage and Handling 107 words ▾

HOW SUPPLIED Loperamide hydrochloride capsules USP, 2 mg are available as: A light brown opaque body and dark brown opaque capsule, imprinted "TEVA" on the cap and "0311" on the body and packaged in bottles of 12, 15, 18, 20, and 60. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container, as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Czech Republic By: TEVA Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454 Rev. N 9/2014

📋 Description 104 words ▾

DESCRIPTION Loperamide hydrochloride is a white to slightly yellow powder and is freely soluble in methanol, isopropyl alcohol, chloroform and slightly soluble in water. Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-α,α-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Its structural formula is: C 29 H 33 ClN 2 O 2 •HCl M.W.

513.51 Loperamide hydrochloride is available in 2 mg capsules. Each capsule, for oral administration, contains 2 mg loperamide hydrochloride. Loperamide hydrochloride capsules USP also contain the inactive ingredients: dimethylpolysiloxane, gelatin, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, pregelatinized corn starch, magnesium stearate, shellac, and titanium dioxide.

Structural formula for loperaminde hydrochloride

💬 Information for Patients 70 words ▾

Information for Patients Patients should be advised to check with their physician if their diarrhea does not improve in 48 hours or if they note blood in their stools, develop a fever or develop abdominal distention. Tiredness, dizziness, or drowsiness may occur in the setting of diarrheal syndromes treated with loperamide hydrochloride. Therefore, it is advisable to use caution when driving a car or operating machinery. (See ADVERSE REACTIONS .)

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 66267-0120-20 · NuCare 66267-0146-12 · NuCare →
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.