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DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 2.5 mg; .025 mg Tablet, 30-count — NDC 72189-0336-30 package photo

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 2.5 mg; .025 mg Tablet, 30-count

by Direct Rx · 30 TABLET in 1 BOTTLE (72189-336-30)
NDC 72189-0336-30
🏷️ FDA NDC (as labeled) 72189-336-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.2597/unit — full pricing hub ↓
Also comes in: 10 tablets 72189-0336-10
Rx only Generic On market CV
🗂️ Data synced Aug 27, 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) 72189-336-30
Product NDC 72189-336
11-digit billing NDC 72189033630
NCPDP billing unit EA — each (per item)
RxCUI 1190572
UNII W24OD7YW48, 03J5ZE7KA5
Application # ANDA213413
SPL Set ID d9a36478-4788-4107-e053-2a95a90ad6da
Established class (EPC) Anticholinergic; Antidiarrheal; Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Antagonists; Cholinergic Muscarinic Antagonists
DEA schedule CV
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-03-07
Route ORAL
Dosage form TABLET
Substance DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
GPI-14 47100010100310
GPI class Diphenoxylate-Atropine
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 72189-336-30 — 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 → 72189-0336-30. 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

LabelerDirect Rx
Application holderLEADING PHARMA LLC
FDA applicationANDA213413 (ANDA)
Labeler code72189
First marketedMar 2022
DEA scheduleCV
Product typeHuman Prescription Drug
Portfolio204 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

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 white
ShapeRound
ImprintLP;910
Size6 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 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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

The official label also statesDiphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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 $0.2597 $7.79 / 30 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 mg 72162-1765-00 Bryant 1000 tablets — AA Discontinued —
Diphenoxylate Hydrochloride And Atropine Sulfate 2.5 mg/1; .025 mgthis 72189-0336-30 Direct 30 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 —
Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg/1; .025 mg 50090-3456-00 A-S 15 tablets — AA Discontinued —
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

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 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
72189-0336-10 10 TABLET in 1 BOTTLE (72189-336-10) 2022-03-07 Active
72189-0336-30 You're viewing this 30 TABLET in 1 BOTTLE (72189-336-30) 2022-03-07 Active

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

Pack size FAQ

What quantity is in NDC 72189-0336-30?
NDC 72189-0336-30 is a 30-count package — 30 tablet in 1 bottle.
What is the difference between NDC 72189-0336-30 and NDC 72189-0336-10?
Both are DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 2.5 mg; .025 mg Tablet — the drug itself is identical. NDC 72189-0336-30 is the 30-count package, while NDC 72189-0336-10 is the 10 tablets package.
What NDC number is used to bill for this package of DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE 2.5 mg; .025 mg Tablet?
Bill NDC 72189-0336-30 — the 11-digit billing format is 72189033630. 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 72189-336-30, 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: 72189-0336-30, written without dashes as 72189033630. 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 72189-0336-30, the first segment (72189) is the labeler code FDA assigned to Direct Rx; the middle segment (0336) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 Direct Rx. 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 1 other package presentation of this same product, including 10 tablets (72189-0336-10). 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?
Direct Rx 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.
⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 🧪 Inactive Ingredients 📋 Description
⏱️ Dosage and Administration ~1 min read ▾

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 tablets. 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, 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 2 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 tablet 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 68 words ▾

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.

🤒 Adverse Reactions 171 words ▾

The following serious adverse reactions are described elsewhere in labeling: Respiratory and/or CNS depression (see WARNINGS) Anticholinergic and opioid-toxicities, including atroponism (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 tablets, 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.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.

🆘 Overdosage 168 words ▾

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 tablets. 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 on the management of poisoning or overdosage.

🧬 Clinical Pharmacology ~1 min read ▾

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 75 words ▾

Tablets - White to off-white, round, tablet debossed with "LP" over "910" on one side and plain on the other side and containing 2.5 mg of diphenoxylate hydrochloride, USP and 0.025 mg of atropine sulfate, USP. Supplied as: NDC 72189-336-09 bottles of 90 tablets NDC 72189-336-01 bottles of 100 tablets NDC 72189-336-10 bottles of 1000 tablets Store below 25°C (77°F). Rx only Manufactured and Distributed by: Leading Pharma, LLC Fairfield, NJ 07004 Rev.

02 05/21

🧪 Inactive Ingredients 24 words ▾

Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.

📋 Description 106 words ▾

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: [ChemicalStructureDiphen] Atropine sulfate, an anticholinergic, is endo-(±)-alpha-(hydroxymethyl) benzeneacetic acid 8-methyl-8- azabicylo[3.2.1] oct-3-yl ester sulfate (2:1)] (salt) monohydrate and has the following structural formula: [ChemicalStructureAtropine] A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage.

Inactive ingredients of diphenoxylate hydrochloride and atropine sulfate tablets include colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch and stearic acid.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72189-0335-05 · Direct 72189-0338-07 · DirectRx →
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.