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Diphenoxylate Hydrochloride and Atropine Sulfate .025 mg; 2.5 mg Tablet, 1,000-count

by Bryant Ranch Prepack · 1000 TABLET in 1 BOTTLE (72162-1765-0)
NDC 72162-1765-00
🏷️ FDA NDC (as labeled) 72162-1765-0 billing pads the package segment with a zero
This package
Contains1,000-count Pack sizes2 compare ↓
Also comes in: 100 tablets 72162-1765-01
Rx only Generic Discontinued CV ⚠ Discontinued by firm
🗂️ Data synced Jul 9, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 72162-1765-0
Product NDC 72162-1765
11-digit billing NDC 72162176500
NCPDP billing unit EA — each (per item)
RxCUI 1190572
UNII 03J5ZE7KA5, W24OD7YW48
Application # ANDA086727
SPL Set ID c69408c2-ccb6-40b1-ae48-e033831c29aa
Established class (EPC) Anticholinergic; Antidiarrheal; Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Antagonists; Cholinergic Muscarinic Antagonists
DEA schedule CV
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 2017-07-07
Route ORAL
Dosage form TABLET
Substance ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
GCN Seq No 002841
GCN 65030
HICL code 001235
Ingredient (HICL) Diphenoxylate Hcl/Atropine
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 12:08.08.00
AHFS class Antimuscarinics/Antispasmodics
FDB label name DIPHENOXYLATE-ATROP 2.5-0.025
FDB brand name Diphenoxylate-Atropine
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 72162-1765-0 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 72162-1765-00. 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, Cholinergic Muscarinic Antagonist
Drug family (ATC) Belladonna alkaloids, tertiary amines, Anticholinergics, Antidotes
How it works Cholinergic Muscarinic Antagonists, 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.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderANI PHARMACEUTICALS INC
FDA applicationANDA086727 (ANDA)
Labeler code72162
First marketedJul 2017
DEA scheduleCV
Product typeHuman Prescription Drug
Portfolio4,434 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 DIPHENOXYLATE-ATROP 2.5-0.025 Ingredient Diphenoxylate Hcl/Atropine
📖 What it is MedlinePlus · NLM

Diphenoxylate is used along with other treatments such as fluid and electrolyte replacement for the treatment of diarrhea. Diphenoxylate should not be given to children younger than 2 years of age. Diphenoxylate is in a class of medications called antidiarrheal agents. It works by decreasing activity of the bowel.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

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

🧪 Inactive Ingredients / Excipients

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

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · 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.
Try another pack size: 100 tablets
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
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 00406-1236-01 SpecGx 100 tablets $0.139 AA Availability likely —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 59762-1061-01 Mylan 100 tablets $0.139 AA Availability likely —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 60687-0890-01 American 100 tablets $0.139 AA Availability likely —
Diphenoxylate hydrochloride and atropine sulfate 2.5 mg/1; .025 mg 62135-0618-12 Chartwell 120 tablets $0.139 AA Availability likely —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 62559-0490-01 ANI 100 tablets $0.139 AA Availability likely —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 69315-0910-01 Leading 100 tablets $0.139 AA Availability likely —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 75826-0107-00 Winder 1000 tablets $0.139 AA Availability likely —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 76385-0107-01 Unichem 100 tablets $0.139 AA Availability likely —
Lomotil 2.5 mg/1; .025 mg 00025-0061-31 Pfizer 100 tablets $3.003 AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 43353-0083-30 Aphena 30 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 43353-0594-30 Aphena 30 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 50090-5589-00 A-S 15 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 50090-5592-00 A-S 20 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 63187-0939-10 Proficient 10 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate .025 mg/1; 2.5 mg 63629-1933-01 Bryant 100 tablets — AA Discontinued —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 67296-1485-09 Redpharm 100 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 67296-2240-05 Redpharm 15 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 68071-4063-01 NuCare 10 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 68788-8090-02 Preferred 20 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 70518-3915-00 REMEDYREPACK 30 tablets — AA Discontinued —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 71205-0909-00 Proficient 100 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 71335-0311-01 Bryant 20 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 71335-1693-01 Bryant 20 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 71610-0714-30 Aphena 30 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 71610-0809-53 Aphena 60 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate .025 mg/1; 2.5 mgthis 72162-1765-00 Bryant 1000 tablets — AA Discontinued —
Diphenoxylate Hydrochloride And Atropine Sulfate 2.5 mg/1; .025 mg 72189-0336-10 Direct 10 tablets — AA FDA listed —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 72789-0375-25 PD-Rx 25 tablets — AA 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

🏛️
2017
On the market since
Jul 2017
📍
2026
Currently FDA-listed
9 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 Diphenoxylate Hydrochloride and Atropine Sulfate — the ingredient across all brands.

Top reported reactions

Diarrhoea2,729
Nausea1,617
Fatigue1,477
Vomiting914
Weight Decreased884
Pain784
Dehydration766

Reporter sex

0 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization5,217
Death1,339
Life-threatening372
Disabling241
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 919 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72162-1765-00 You're viewing this 1000 TABLET in 1 BOTTLE (72162-1765-0) 2024-02-01 Discontinued by firm
72162-1765-01 100 TABLET in 1 BOTTLE (72162-1765-1) 2024-02-01 Discontinued by firm

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

Pack size FAQ

What quantity is in NDC 72162-1765-00?
NDC 72162-1765-00 is a 1,000-count package — 1000 tablet in 1 bottle.
What is the difference between NDC 72162-1765-00 and NDC 72162-1765-01?
Both are Diphenoxylate Hydrochloride and Atropine Sulfate .025 mg; 2.5 mg Tablet — the drug itself is identical. NDC 72162-1765-00 is the 1,000-count package, while NDC 72162-1765-01 is the 100 tablets package.
What NDC number is used to bill for this package of Diphenoxylate Hydrochloride and Atropine Sulfate .025 mg; 2.5 mg Tablet?
Bill NDC 72162-1765-00 — the 11-digit billing format is 72162176500. 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 No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 72162-1765-0, 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: 72162-1765-00, written without dashes as 72162176500. 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 72162-1765-00, the first segment (72162) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (1765) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (72162-1765-01). 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?
Bryant Ranch Prepack 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 28 words ▾

INDICATIONS AND USAGE Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Management of Diarrhea in Patients 13 Years of Age and Older Diphenoxylate hydrochloride and atropine sulfate tablets are recommended as adjunctive therapy for the management of diarrhea in patients 13 years of age and older. Consider the nutritional status and degree of dehydration in patients prior to initiating therapy with diphenoxylate hydrochloride and atropine sulfate. The use of this product should be accompanied by appropriate fluid and electrolyte therapy, when indicated.

If severe dehydration or electrolyte imbalance is present, do not administer diphenoxylate hydrochloride and atropine sulfate tablets until appropriate corrective therapy has been indicated (see WARNINGS ). Initial and Maximum Recommended Dosage in Patients 13 Years of Age and Older The initial adult dosage is two diphenoxylate hydrochloride and atropine sulfate tablets four times daily (maximum total daily dose of 20 mg per day of diphenoxylate hydrochloride). Most patients will require this dosage until initial control of diarrhea has been achieved.

Clinical improvement of acute diarrhea is usually observed within 48 hours. Dosage After Initial Control of Diarrhea After initial control has been achieved, the diphenoxylate hydrochloride and atropine sulfate dosage may be reduced to meet individual requirements. Control may often be maintained with as little as two diphenoxylate hydrochloride and atropine sulfate tablets daily.

Duration of Treatment If clinical improvement of chronic diarrhea after treatment with the maximum recommended daily dosage is not observed within 10 days, discontinue diphenoxylate hydrochloride and atropine sulfate tablets as symptoms are unlikely to be controlled by further administration.

⛔ Contraindications 75 words ▾

CONTRAINDICATIONS Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in: • Pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS) depression (see WARNINGS ). • Patients with diarrhea associated with pseudomembranous enterocolitis (Clostridium difficile) or other enterotoxin-producing bacteria due to the risk of gastrointestinal (GI) complications, including sepsis (see WARNINGS ). • Patients with known hypersensitivity to diphenoxylate or atropine. • Patients with obstructive jaundice.

⚠️ Warnings ~2 min read ▾

WARNINGS Respiratory and/or CNS Depression in Pediatric Patients Less than 6 Years of Age Cases of severe respiratory depression and coma, leading to permanent brain damage or death have been reported in patients less than 6 years of age who received diphenoxylate hydrochloride and atropine sulfate tablets. Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in patients less than 6 years of age due to these risks (see CONTRAINDICATIONS ). Anticholinergic and Opioid-Toxicities Toxicities associated with the atropine and diphenoxylate components of this product have been reported.

The initial presenting symptoms may be delayed by up to 30 hours due to prolonged gastric emptying time induced by the diphenoxylate hydrochloride. Clinical presentations vary in terms of which toxicity (anticholinergic vs. opioid) will present first or predominate; non-specific findings have been reported and include symptoms such as drowsiness (see OVERDOSAGE ). Dehydration and Electrolyte Imbalance The use of diphenoxylate hydrochloride and atropine sulfate tablets should be accompanied by appropriate fluid and electrolyte therapy, when indicated.

If severe dehydration or electrolyte imbalance is present, diphenoxylate hydrochloride and atropine sulfate tablets should be withheld until appropriate corrective therapy has been initiated. Drug-induced inhibition of peristalsis may result in fluid retention in the intestine, which may further aggravate dehydration and electrolyte imbalance. Gastrointestinal Complications in Patients with Infectious Diarrhea Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in patients with diarrhea associated with organisms that penetrate the GI mucosa (toxigenic E. coli , Salmonella , Shigella ), and pseudomembranous enterocolitis ( Clostridium difficile ) associated with broad-spectrum antibiotics (see CONTRAINDICATIONS ).

Antiperistaltic agents, including diphenoxylate hydrochloride and atropine sulfate, slow gastrointestinal motility and may enhance bacterial overgrowth and the release of bacterial exotoxins. Diphenoxylate hydrochloride and atropine sulfate has been reported to result in serious GI complications in patients with infectious diarrhea, including sepsis, prolonged and/or worsened diarrhea. Prolonged fever and the delay in the resolution of stool pathogens were reported in study of Shigellosis in adults who used diphenoxylate hydrochloride and atropine sulfate vs. placebo.

Toxic Megacolon in Patients with Acute Ulcerative Colitis In some patients with acute ulcerative colitis, agents that inhibit intestinal motility or prolong intestinal transit time have been reported to induce toxic megacolon. Consequently, patients with acute ulcerative colitis should be carefully observed and diphenoxylate hydrochloride and atropine sulfate therapy should be discontinued promptly if abdominal distention occurs or if other untoward symptoms develop. Interaction with Meperidine Hydrochloride Since the chemical structure of diphenoxylate hydrochloride is similar to that of meperidine hydrochloride, the concurrent use of diphenoxylate hydrochloride and atropine sulfate tablets with monoamine oxidase (MAO) inhibitors may, in theory, precipitate hypertensive crisis.

Hepatorenal Disease Diphenoxylate hydrochloride and atropine sulfate tablets should be used with extreme caution in patients with advanced hepatorenal disease and in all patients with abnormal liver function since hepatic coma may be precipitated. Interaction with CNS Depressants Diphenoxylate hydrochloride may potentiate the action of other drugs that cause dizziness or drowsiness, including barbiturates, benzodiazepines and other sedatives/hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, and alcohol.

Therefore, the patient should be closely observed when any of these are used concomitantly.

🤒 Adverse Reactions 158 words ▾

ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Respiratory and/or CNS depression (see WARNINGS ) • Anticholinergic and opioid-toxicities, including atropinism (see WARNINGS and PRECAUTIONS ) • Dehydration and electrolyte imbalance (see WARNINGS ) • GI Complications in patients with infectious diarrhea (see WARNINGS ) • Toxic megacolon in patients with acute ulcerative colitis (see WARNINGS ) At therapeutic doses of diphenoxylate hydrochloride and atropine sulfate, the following other adverse reactions have been reported; they are listed in decreasing order of severity, but not of frequency: Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache, hallucination.

Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus. Gastrointestinal system: megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort. The following adverse reactions related to atropine sulfate are listed in decreasing order of severity, but not of frequency: hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes.

🔄 Drug Interactions 156 words ▾

Drug Interactions Alcohol Alcohol may increase the CNS depressant effects of diphenoxylate hydrochloride and atropine sulfate and may cause drowsiness (see WARNINGS ). Avoid concomitant use of diphenoxylate hydrochloride and atropine sulfate tablets with alcohol. Other Drugs that Cause CNS Depression The concurrent use of diphenoxylate hydrochloride and atropine sulfate with other drugs that cause CNS depression (e.g., barbiturates, benzodiazepines, opioids, buspirone, antihistamines, muscle relaxants), may potentiate the effects of diphenoxylate hydrochloride and atropine sulfate (see WARNINGS ).

Either diphenoxylate hydrochloride and atropine sulfate tablets or the other interacting drug should be chosen, depending on the importance of the drug to the patient. If CNS-acting drugs cannot be avoided, monitor patients for CNS adverse reactions. MAO Inhibitors Diphenoxylate may interact with monoamine oxidase inhibitors (MAOIs) and precipitate a hypertensive crisis.

Avoid use of diphenoxylate hydrochloride and atropine sulfate tablets in patients who take MAOIs and monitor for signs and symptoms of hypertensive crisis (headache, hyperthermia, hypertension).

🤰 Pregnancy 147 words ▾

Pregnancy Diphenoxylate hydrochloride has been shown to have an effect on fertility in rats when given in doses 50 times the human dose (see above discussion). Other findings in this study include a decrease in maternal weight gain of 30% at 20 mg/kg/day and of 10% at 4 mg/kg/day. At 10 times the human dose (4 mg/kg/day), average litter size was slightly reduced.

Teratology studies were conducted in rats, rabbits, and mice with diphenoxylate hydrochloride at oral doses of 0.4 to 20 mg/kg/day. Due to experimental design and small numbers of litters, embryotoxic, fetotoxic, or teratogenic effects cannot be adequately assessed. However, examination of the available fetuses did not reveal any indication of teratogenicity.

There are no adequate and well-controlled studies in pregnant women. Diphenoxylate hydrochloride and atropine sulfate tablets should be used during pregnancy only if the anticipated benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 129 words ▾

Pediatric Use The safety and effectiveness of diphenoxylate hydrochloride and atropine sulfate tablets have been established in pediatric patients 13 years of age and older as adjunctive therapy in the management of diarrhea. The safety and effectiveness of this product has not been established in pediatric patients less than 13 years of age. Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in pediatric patients less than 6 years of age due to the risks of severe respiratory depression and coma, possibly resulting in permanent brain damage or death (see CONTRAINDICATIONS ).

Diphenoxylate hydrochloride and atropine sulfate has caused atropinism, particularly in pediatric patients with Down’s Syndrome (see PRECAUTIONS ). In case of accidental ingestion of diphenoxylate hydrochloride and atropine sulfate tablets by pediatric patients, see OVERDOSAGE for recommended treatment.

🆘 Overdosage 168 words ▾

OVERDOSAGE Diagnosis Overdosage can be life-threatening. Symptoms of overdosage may include opioid and/or anticholinergic effects including respiratory depression, coma, delirium, lethargy, dryness of the skin and mucous membranes, mydriasis or miosis, flushing, hyperthermia, tachycardia, hypotonia, tachypnea, toxic encephalopathy, seizures and incoherent speech. Respiratory depression has been reported up to 30 hours after ingestion and may recur despite an initial response to narcotic antagonists.

Treat all possible diphenoxylate hydrochloride and atropine sulfate overdosages as serious and maintain medical observation/hospitalization until patients become asymptomatic without naloxone use. Treatment A pure narcotic antagonist (e.g., naloxone) should be used in the treatment of respiratory depression caused by diphenoxylate hydrochloride and atropine sulfate. Refer to the prescribing information for naloxone.

Consider diphenoxylate hydrochloride and atropine sulfate toxicity even in settings of negative toxicology tests. Following initial improvement of respiratory function, repeated doses of naloxone hydrochloride may be required to counteract recurrent respiratory depression. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information of the management of poisoning or overdosage.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Diphenoxylate is rapidly and extensively metabolized in man by ester hydrolysis to diphenoxylic acid (difenoxine), which is biologically active and the major metabolite in the blood. After a 5 mg oral dose of carbon-14 labeled diphenoxylate hydrochloride in ethanolic solution was given to three healthy volunteers, an average of 14% of the drug plus its metabolites was excreted in the urine and 49% in the feces over a four-day period. Urinary excretion of the unmetabolized drug constituted less than 1% of the dose, and diphenoxylic acid plus its glucuronide conjugate constituted about 6% of the dose.

In a 16-subject crossover bioavailability study, a linear relationship in the dose range of 2.5 to 10 mg was found between the dose of diphenoxylate hydrochloride (given as diphenoxylate hydrochloride and atropine sulfate liquid) and the peak plasma concentration, the area under the plasma concentration-time curve, and the amount of diphenoxylic acid excreted in the urine. In the same study the bioavailability of the tablet compared with an equal dose of the liquid was approximately 90%. The average peak plasma concentration of diphenoxylic acid following ingestion of four 2.5 mg tablets was 163 ng/mL at about 2 hours, and the elimination half-life of diphenoxylic acid was approximately 12 to 14 hours.

In dogs, diphenoxylate hydrochloride has a direct effect on circular smooth muscle of the bowel that conceivably results in segmentation and prolongation of gastrointestinal transit time. The clinical antidiarrheal action of diphenoxylate hydrochloride may thus be a consequence of enhanced segmentation that allows increased contact of the intraluminal contents with the intestinal mucosa.

📦 How Supplied / Storage and Handling 85 words ▾

HOW SUPPLIED Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP are available as round white tablets debossed ‘490’ on one side and plain on the other side. Each tablet contains 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate. NDC: 72162-1765-1: 100 Tablets in a BOTTLE NDC: 72162-1765-0: 1000 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP controlled room temperature].

Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 106 words ▾

DESCRIPTION Each Diphenoxylate Hydrochloride and Atropine Sulfate Tablet USP contains: 2.5 mg of diphenoxylate hydrochloride USP (equivalent to 2.3 mg of diphenoxylate) and 0.025 mg of atropine sulfate USP (equivalent to 0.01 mg of atropine) Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride and has the following structural formula: Atropine sulfate, an anticholinergic, is endo-(±)-α-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1) (salt) monohydrate and has the following structural formula: A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage.

Each diphenoxylate hydrochloride and atropine sulfate tablet contains the following inactive ingredients: confectioner’s sugar, corn starch, lactose monohydrate, magnesium stearate, and sodium starch glycolate.

💬 Information for Patients ~1 min read ▾

Information for Patients Advise Patients: • Accidental ingestion of diphenoxylate hydrochloride and atropine sulfate tablets in children, especially in those less than 6 years of age, may result in severe respiratory depression and coma. Instruct patients to take steps to store diphenoxylate hydrochloride and atropine sulfate tablets securely and out of reach of children, and to dispose of unused diphenoxylate hydrochloride and atropine sulfate tablets (see WARNINGS ). • To take diphenoxylate hydrochloride and atropine sulfate tablets at the prescribed dosage.

Use of a higher than prescribed dosage may include opioid and/or anticholinergic effects (see OVERDOSAGE ). Report to a healthcare facility if they develop anticholinergic symptoms such as hyperthermia, flushing, tachycardia, tachypnea, hypotonia, lethargy, hallucinations, febrile convulsion, dry mouth, mydriasis or opioid symptoms such as progressive CNS and respiratory depression, miosis, seizures, or paralytic ileus. • Diphenoxylate hydrochloride and atropine sulfate tablets may produce drowsiness or dizziness. Concomitant use of alcohol or other drugs that also cause CNS depression (e.g., barbiturates, benzodiazepines, opioids, buspirone, antihistamines, and muscle relaxants) may increase this effect.

Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that diphenoxylate hydrochloride and atropine sulfate tablets do not affect them adversely. • To use fluid and electrolyte therapy, if prescribed along with diphenoxylate hydrochloride and atropine sulfate tablets, as instructed by their healthcare provider. • Clinical improvement of diarrhea is usually observed within 48 hours. If clinical improvement is not seen within 10 days, discontinue diphenoxylate hydrochloride and atropine sulfate tablets and contact their healthcare provider.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72162-1764-03 · Bryant 72162-1766-01 · Bryant →
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.