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Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg; .025 mg Tablet, 100-count — NDC 62559-490-01 (Billing 62559-0490-01)

by ANI Pharmaceuticals, Inc. · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg; .025 mg Tablet from ANI Pharmaceuticals, Inc., marketed since Jul 2017 and currently FDA-listed; retail pharmacies pay about $0.1389 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 62559-0490-01
🏷️ FDA NDC (as labeled) 62559-490-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.1389 NADAC Per package$13.89 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.3695/unit · Part D plans $0.2597/unit — full pricing hub ↓
Main listing for product 62559-490 · Also comes in: 1000 tablets 62559-490-10
Rx only Generic On market CV ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62559-490-01
Product NDC 62559-490
11-digit billing NDC 62559049001
NCPDP billing unit EA — each (per item)
RxCUI 1190572
UNII W24OD7YW48, 03J5ZE7KA5
UPC 0362559490016
Application # ANDA086727
SPL Set ID 73dc5f91-d562-44c5-a556-66c96ed1dd82
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 2017-07-07
Route ORAL
Dosage form TABLET
Substance DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

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
Quick answers
  • GSN (GCN sequence number): 002841
  • GCN: 65030
  • GPI-14 (Medi-Span): 47100010100310
  • HICL (First Databank): 001235
  • AHFS class code: 12:08.08.00
  • RxCUI (RxNorm): 1190572
Why two NDCs? The FDA registers this code as 62559-490-01 — 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 → 62559-0490-01. 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.

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.

Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.139 $13.89 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.3695 $36.95 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.2597 $25.97 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.227 $0.137
▼ Down 29% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
62559-0490-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE $0.1389 / ea $13.89 2017-07-07 — Active
62559-0490-10 62559-490-10 1000 TABLET in 1 BOTTLE $0.1389 / ea $138.85 2017-07-07 — Active

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

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1389 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 62559-0490-10?
Both are Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg; .025 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 62559-0490-10 is the 1000 tablets package.
What NDC number is used to bill for this package of Diphenoxylate Hydrochloride and Atropine Sulfate 2.5 mg; .025 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diphenoxylate hydrochloride and atropine sulfate 2.5 mg/1; .025 mg 62135-0618-12 Chartwell 120 tablets $0.139 AA Availability likely +0%
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 mgthis 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 $2.991 AA Availability likely +2054%
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 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 —
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

🏛️
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.

What it looks like

Color White
ShapeRound
Imprint490
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 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 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • 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.

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

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerANI Pharmaceuticals, Inc.
Application holderANI PHARMACEUTICALS INC
FDA applicationANDA086727 (ANDA)
Labeler code62559
First marketedJul 2017
DEA scheduleCV
Product typeHuman Prescription Drug
Portfolio299 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 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 ⚠️ Precautions 🍼 Nursing Mothers 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 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 175 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.

To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 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 91 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 and are supplied as: NDC Number Size 62559-490-01 Bottle of 100 tablets 62559-490-10 Bottle of 1,000 tablets 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]. Manufactured by: ANI Pharmaceuticals, Inc.

Baudette, MN 56623 9981 Rev 09/25 ani.jpg

📋 Description 112 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: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate. Diphen-structure.jpg Atrop-structure.jpg

💬 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.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Atropinism Since a subtherapeutic dose of atropine has been added to the diphenoxylate hydrochloride, consideration should be given to the development of adverse reactions associated with atropine (see WARNINGS ). Diphenoxylate hydrochloride and atropine sulfate has caused atropinism (hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes) particularly in pediatric patients with Down's Syndrome. Diphenoxylate hydrochloride and atropine sulfate tablets are not indicated for use in pediatric patients (see CONTRAINDICATIONS and WARNINGS ).

Monitor patients for signs of atropinism. 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.

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). Carcinogenesis, Mutagenesis, and Impairment of Fertility No long-term study in animals has been performed to evaluate carcinogenic potential. Diphenoxylate hydrochloride was administered to male and female rats in their diets to provide dose levels of 4 and 20 mg/kg/day throughout a three-litter reproduc… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 51 words ▾

Nursing Mothers Caution should be exercised when diphenoxylate hydrochloride and atropine sulfate tablets are administered to a nursing woman, since the physicochemical characteristics of the major metabolite, diphenoxylic acid, are such that it may be excreted in breast milk and since it is known that atropine is excreted in breast milk.

🔒 Drug Abuse and Dependence ~1 min read ▾

DRUG ABUSE AND DEPENDENCE Controlled Substance Diphenoxylate hydrochloride and atropine sulfate tablets are classified as a Schedule V controlled substance by federal regulation. Diphenoxylate hydrochloride is chemically related to the narcotic analgesic meperidine. Drug Abuse and Dependence In doses used for the treatment of diarrhea, whether acute or chronic, diphenoxylate has not produced addiction.

Diphenoxylate hydrochloride is devoid of morphine-like subjective effects at therapeutic doses. At high doses it exhibits codeine-like subjective effects. The dose which produces antidiarrheal action is widely separated from the dose which causes central nervous system effects.

The insolubility of diphenoxylate hydrochloride in commonly available aqueous media precludes intravenous self-administration. A dose of 100 to 300 mg/day, which is equivalent to 40 to 120 tablets, administered to humans for 40 to 70 days, produced opiate withdrawal symptoms. Since addiction to diphenoxylate hydrochloride is possible at high doses, the recommended dosage should not be exceeded.

Drug Abuse and Dependence In doses used for the treatment of diarrhea, whether acute or chronic, diphenoxylate has not produced addiction. Diphenoxylate hydrochloride is devoid of morphine-like subjective effects at therapeutic doses. At high doses it exhibits codeine-like subjective effects.

The dose which produces antidiarrheal action is widely separated from the dose which causes central nervous system effects. The insolubility of diphenoxylate hydrochloride in commonly available aqueous media precludes intravenous self-administration. A dose of 100 to 300 mg/day, which is equivalent to 40 to 120 tablets, administered to humans for 40 to 70 days, produced opiate withdrawal symptoms.

Since addiction to diphenoxylate hydrochloride is possible at high doses, the recommended dosage should not be exceeded.

🔒 Controlled Substance 29 words ▾

Controlled Substance Diphenoxylate hydrochloride and atropine sulfate tablets are classified as a Schedule V controlled substance by federal regulation. Diphenoxylate hydrochloride is chemically related to the narcotic analgesic meperidine.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 94 words ▾

Carcinogenesis, Mutagenesis, and Impairment of Fertility No long-term study in animals has been performed to evaluate carcinogenic potential. Diphenoxylate hydrochloride was administered to male and female rats in their diets to provide dose levels of 4 and 20 mg/kg/day throughout a three-litter reproduction study. At 50 times the human dose (20 mg/kg/day), female weight gain was reduced and there was a marked effect on fertility as only 4 of 27 females became pregnant in three test breedings.

The relevance of this finding to usage of diphenoxylate hydrochloride and atropine sulfate in humans is unknown.

📄 Package Label / Principal Display Panel 22 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV 2.5 mg/0.025 mg NDC 62559-490-01 Rx only 100 Tablets label

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
121
Units reimbursed last 4 qtrs
6K
Gross reimbursed last 4 qtrs
$2.2K
Avg / prescription
$18.25
Avg / unit
$0.3695
Latest quarter Q1 2026
11Rx
Medicaid pays / ea
$0.3695
gross reimbursed
vs
NADAC / ea
$0.1389
acquisition cost
=
Spread
+$0.2306
+166% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
58% FFS 42% MCO
Fee-for-service · 70 Rx Managed care · 51 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 2,965 units · 15.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 528 units · 5.7 per 100k residents NJ Massachusetts: no data reported MA California: 658 units · 1.7 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 1,826 units · 40.3 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.740.3
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 40.3 /100k
2 New York 15.1 /100k
3 New Jersey 5.7 /100k
4 California 1.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets this page62559-0490-01 121 Rx · $2,209
1000 tablets62559-0490-10 No Medicaid data
Drug total (last 4 qtrs): 121 Rx · 5,977 units · $2,209 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
← 62559-0486-12 · ANI 62559-0510-01 · ANI →
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.