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Loperamide hydrochloride 2 mg Capsule, 500-count — NDC 72578-0138-05 package photo

Loperamide hydrochloride 2 mg Capsule, 500-count

by Viona Pharmaceuticals Inc · 500 CAPSULE in 1 BOTTLE (72578-138-05)
NDC 72578-0138-05
🏷️ FDA NDC (as labeled) 72578-138-05 billing pads the product segment with a zero
This package
Contains500-count Cost per ea$0.0565 NADAC Per package$28.25 / 500 capsules Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.2894/unit · Part D plans $0.2376/unit — full pricing hub ↓
Also comes in: 100 capsules 72578-0138-01 100 capsules 72578-0138-77
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 72578-138-05
Product NDC 72578-138
11-digit billing NDC 72578013805
NCPDP billing unit EA — each (per item)
RxCUI 978006
UNII 77TI35393C
Application # ANDA217471
SPL Set ID 330677ff-5426-40bd-af45-e3836cb77893
Established class (EPC) Opioid Agonist
Mechanism of action Opioid Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-06-25
Route ORAL
Dosage form CAPSULE
Substance LOPERAMIDE HYDROCHLORIDE
GPI-14 47100020100105
GCN Seq No 002842
GCN 08370
HICL code 001236
Ingredient (HICL) Loperamide Hcl
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6D
Therapeutic class — specific (HIC3) Antidiarrheals
AHFS code 56:08.00.00
AHFS class Antidiarrhea Agents
FDB label name LOPERAMIDE 2 MG CAPSULE
FDB brand name Loperamide
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72578-138-05 — 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 → 72578-0138-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Antipropulsives
How it works Opioid Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerViona Pharmaceuticals Inc
Application holderZYDUS LIFESCIENCES LTD
FDA applicationANDA217471 (ANDA)
Labeler code72578
First marketedJun 2023
Product typeHuman Prescription Drug
Portfolio94 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name LOPERAMIDE 2 MG CAPSULE Ingredient Loperamide Hcl
📗 Our plain-language guide HelloPharmacist
  • Loperamide works by binding to the same type of receptors in your gut that opioids do, but it stays mostly in the intestines and very little gets into your bloodstream at the recom...
  • What exactly does loperamide do — and is it like taking an opioid?
  • For acute diarrhea, stop and call your doctor if symptoms don't improve within 2 days, or if they get worse. You should also stop right away if you develop bloating or a swollen be...
  • How long can I take loperamide before I should see a doctor?
📖 Read our full Loperamide guide →

Supplement & herbal interactions

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

💊 What it looks like

Color Yellow
ShapeCapsule
Imprint1701
Size16 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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 eaPer package
Retail pharmacies payNADAC · weekly $0.057 $28.25 / 500 capsules
Medicaid paysCMS SDUD · 12 mo $0.2894 $144.70 / 500 capsules
Medicare drug plans payPart D · Q2 2026 $0.2376 $118.80 / 500 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $0.239 $0.052
▼ Down 76% over the last 12 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Loperamide Hydrochloride 2 mg 00093-0311-01 Teva 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 00378-2100-01 Mylan 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 00904-7472-61 Major 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 42799-0605-01 Edenbridge 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 50268-0482-15 AvPAK 50 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 51079-0690-20 Mylan 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 59651-0691-01 Aurobindo 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 60687-0229-01 American 100 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 69452-0271-20 Bionpharma 100 capsules $0.056 AB Availability likely —
Loperamide hydrochloride 2 mgthis 72578-0138-05 Viona 500 capsules $0.056 AB Availability likely —
Loperamide Hydrochloride 2 mg 72603-0328-01 NorthStar 100 capsules $0.056 AB Availability likely —
Anti-Diarrheal 2 mg 46122-0581-62 AMERISOURCE 12 capsules $0.136 — Availability likely +141%
Anti-Diarrheal 2 mg 70000-0461-01 CARDINAL 12 capsules $0.136 — Availability likely +141%
Anti-Diarrheal 2 mg 70677-1062-01 STRATEGIC 12 capsules $0.136 — Availability likely +141%
Anti-Diarrheal 2 mg 83324-0208-12 CHAIN 12 capsules $0.136 — Availability likely +141%
Anti-Diarrheal 2 mg 83324-0209-24 CHAIN 12 capsules $0.136 — Availability likely +141%
Anti-Diarrheal 2 mg 63868-0876-12 CHAIN 12 capsules $0.140 — FDA listed +147%
Anti-Diarrheal 2 mg 62011-0390-01 Strategic 12 capsules $0.150 — FDA listed +166%
Anti-Diarrheal 2 mg 00363-1176-08 WALGREENS 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 00615-8497-39 NCS 30 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 11673-0177-12 TARGET 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 11822-7834-02 Rite 12 capsules — — FDA listed —
anti-diarrheal 2 mg 21130-0835-12 Albertsons 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 30142-0159-08 KROGER 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 36800-0208-12 TOP 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 37808-0988-12 HEB 12 capsules — — FDA listed —
anti-diarrheal 2 mg 41250-0210-08 MEIJER 12 capsules — — FDA listed —
First Aid Direct Anti-Diarrheal 2 mg 42961-0103-02 Cintas 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 43063-0020-12 PD-Rx 12 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 43598-0770-24 Dr. 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 48433-0063-20 Safecor 100 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 49035-0483-12 Wal-Mart 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 50090-0460-00 A-S 15 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 50090-7398-00 A-S 15 capsules — AB FDA listed —
Imodium A-D 2 mg 50580-0367-01 Kenvue 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 51407-0999-01 Golden 100 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 53943-0176-12 DISCOUNT 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 55154-4699-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 55154-5585-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 55289-0315-06 PD-Rx 6 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 55910-0176-08 DOLGENCORP, 12 capsules — — FDA listed —
anti-diarrheal 2 mg 56062-0680-12 PUBLIX 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 58602-0727-74 Aurohealth 6 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 60468-0005-01 allphamed 100 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 63629-8747-01 Bryant 100 capsules — AB FDA listed —
anti-diarrheal 2 mg 63941-0684-12 VALU 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 66267-0132-12 NuCare 12 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 67046-1676-03 Coupler 30 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 67296-2172-01 Redpharm 15 capsules — AB FDA listed —
Anti-Diarrheal 2 mg 68016-0058-12 Premier 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 68071-2257-06 NuCare 6 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 68071-2700-01 NuCare 12 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 68071-3618-01 NuCare 12 capsules — AB FDA listed —
anti-diarrheal 2 mg 69452-0176-12 Bionpharma 24 capsules — — FDA listed —
anti-diarrheal 2 mg 69452-0266-12 Bionpharma 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 69842-0061-12 CVS 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 70518-4283-00 REMEDYREPACK 30 capsules — AB FDA listed —
Loperamide hydrochloride 2 mg 70771-1769-01 Zydus 100 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-1921-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2061-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2111-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2487-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71335-2571-00 Bryant 50 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0648-53 Aphena 60 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0781-53 Aphena 60 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0950-30 Aphena 30 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 71610-0973-53 Aphena 60 capsules — AB FDA listed —
anti-diarrheal 2 mg 72288-0313-12 Amazon.com 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 72888-0130-00 Advagen 1000 capsules — AB FDA listed —
WELMATE Anti Diarrheal Loperamide HCl Softgels 2 mg 73581-0102-24 YYBA 24 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 75907-0097-12 Dr. 12 capsules — — FDA listed —
Anti-Diarrheal 2 mg 80136-0851-42 Northeast 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 55154-0277-00 Cardinal 10 capsules — AB FDA listed —
Loperamide Hydrochloride 2 mg 59556-0959-05 Strides 12 capsules — — FDA listed —
Loperamide Hydrochloride 2 mg 73581-0177-02 YYBA 12 capsules — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 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.

🗺️ 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 72578-0138-05, 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 – Q4 2025 · 4 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
26.6K
Units reimbursed last 4 qtrs
1.2M
Gross reimbursed last 4 qtrs
$358.4K
Avg / prescription
$13.48
Avg / unit
$0.2894
Latest quarter Q4 2025
6.8KRx
Medicaid pays / ea
$0.2894
gross reimbursed
vs
NADAC / ea
$0.0565
acquisition cost
=
Spread
+$0.2329
+412% 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 ⓘ
50% FFS 50% MCO
Fee-for-service · 13,271 Rx Managed care · 13,313 Rx
State Medicaid map
Alaska: no data reported AK Maine: 6,430 units · 461 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: 7,592 units · 671 per 100k residents MT North Dakota: no data reported ND Minnesota: 32,503 units · 567 per 100k residents MN Wisconsin: 32,065 units · 543 per 100k residents WI Michigan: 86,169 units · 859 per 100k residents MI New York: 240,288 units · 1,228 per 100k residents NY Vermont: 640 units · 98.9 per 100k residents VT New Hampshire: no data reported NH Oregon: 11,807 units · 279 per 100k residents OR Nevada: 7,114 units · 223 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 6,324 units · 197 per 100k residents IA Illinois: 22,824 units · 182 per 100k residents IL Indiana: 15,462 units · 225 per 100k residents IN Ohio: 120,687 units · 1,024 per 100k residents OH Pennsylvania: 125,576 units · 969 per 100k residents PA New Jersey: 51,076 units · 550 per 100k residents NJ Massachusetts: 21,427 units · 306 per 100k residents MA California: 164,994 units · 423 per 100k residents CA Utah: 3,438 units · 101 per 100k residents UT Colorado: 6,806 units · 116 per 100k residents CO Nebraska: 6,090 units · 308 per 100k residents NE Missouri: 21,566 units · 348 per 100k residents MO Kentucky: 83,602 units · 1,847 per 100k residents KY West Virginia: 13,878 units · 784 per 100k residents WV Virginia: 28,472 units · 327 per 100k residents VA Maryland: 17,736 units · 287 per 100k residents MD Connecticut: 15,651 units · 433 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,652 units · 22.2 per 100k residents AZ New Mexico: no data reported NM Kansas: 1,899 units · 64.6 per 100k residents KS Arkansas: no data reported AR Tennessee: 7,035 units · 98.7 per 100k residents TN North Carolina: 16,993 units · 157 per 100k residents NC South Carolina: 2,263 units · 42.1 per 100k residents SC Delaware: 2,934 units · 285 per 100k residents DE Oklahoma: 4,773 units · 118 per 100k residents OK Louisiana: 2,119 units · 46.3 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 7,155 units · 64.9 per 100k residents GA D.C.: 2,332 units · 343 per 100k residents DC Hawaii: no data reported HI Texas: 12,544 units · 41.1 per 100k residents TX Florida: 25,423 units · 112 per 100k residents FL
Units reimbursed · per 100k residents
22.21,847
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 1,847 /100k
2 New York 1,228 /100k
3 Ohio 1,024 /100k
4 Pennsylvania 969 /100k
5 Michigan 859 /100k
6 West Virginia 784 /100k
7 Montana 671 /100k
8 Minnesota 567 /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 capsules72578-0138-01 45,522 Rx · $598,308
500 capsules this page72578-0138-05 28,629 Rx · $377,497
100 capsules72578-0138-77 No Medicaid data
Drug total (last 4 qtrs): 74,151 Rx · 3,736,508 units · $975,805 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

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

Age at onset

Neonate13
Infant24
Child103
Adolescent111
Adult5,069
Elderly7,388

Reporter sex

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

Serious outcomes

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

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
72578-0138-01 100 CAPSULE in 1 BOTTLE (72578-138-01) $0.0565 / ea $5.65 2023-06-25 Active
72578-0138-05 You're viewing this 500 CAPSULE in 1 BOTTLE (72578-138-05) $0.0565 / ea $28.25 2023-06-25 Active
72578-0138-77 10 BLISTER PACK in 1 CARTON (72578-138-77) / 10 CAPSULE in 1 BLISTER PACK (72578-138-30) — — 2023-06-25 Active

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0565 NADAC).

This pack accounts for about 39% of this product's recent Medicaid fills; most go to the 100 capsules pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 72578-0138-05?
NDC 72578-0138-05 is a 500-count package — 500 capsule in 1 bottle.
What is the difference between NDC 72578-0138-05 and NDC 72578-0138-01?
Both are Loperamide hydrochloride 2 mg Capsule — the drug itself is identical. NDC 72578-0138-05 is the 500-count package, while NDC 72578-0138-01 is the 100 capsules package.
What NDC number is used to bill for this package of Loperamide hydrochloride 2 mg Capsule?
Bill NDC 72578-0138-05 — the 11-digit billing format is 72578013805. 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.

📄 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🚨 Boxed Warning 84 words ▾

WARNING: TORSADES DE POINTES AND SUDDEN DEATH Cases of Torsades de Pointes, cardiac arrest and death have been reported with the use of a higher than recommended dosages of loperamide hydrochloride (see WARNINGS and OVERDOSAGE ). Loperamide hydrochloride is contraindicated in pediatric patients less than 2 years of age (see CONTRAINDICATIONS ). Avoid loperamide hydrochloride dosages higher than recommended in adults and pediatric patients 2 years of age and older due to the risk of serious cardiac adverse reactions (see DOSAGE AND ADMINISTRATION ).

🎯 Indications and Usage 51 words ▾

INDICATIONS AND USAGE Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Loperamide hydrochloride is contraindicated in pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions (see CONTRAINDICATIONS ). Avoid Loperamide hydrochloride dosages higher than recommended in adult or pediatric patients 2 years of age and older due to the risk of serious cardiac adverse reactions (See WARNINGS , OVERDOSAGE ). (1 capsule = 2 mg) Patients should receive appropriate fluid and electrolyte replacement as needed.

Acute Diarrhea Adults and Pediatric Patients 13 Years and Older The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. The maximum daily dose is 16 mg (eight capsules). Clinical improvement is usually observed within 48 hours.

Pediatric Patients 2 Years to 12 Years of Age In pediatric patients 2 years to 5 years of age (20 kg or less), the non-prescription liquid formulation (Imodium A-D 1 mg/5 mL) should be used; for ages 6 to 12, either loperamide hydrochloride capsules or Imodium A-D liquid may be used. For pediatric patients 2 years to 12 years of age, the following schedule for capsules or liquid will usually fulfill initial dosage requirements: Recommended First Day Dosage Schedule Two years to five years (13 kg to 20 kg): 1 mg three times daily (3 mg total daily dosage) Six years to eight years (20 kg to 30 kg): 2 mg twice daily.

(4 mg total daily dosage) Eight years to twelve years (greater than 30kg): 2 mg three times daily (6 mg total daily dosage) Recommended Subsequent Daily Dosage Following the first treatment day, it is recommended that subsequent loperamide hydrochloride doses (1 mg/10 kg body weight) be administered only after a loose stool. The total daily dosage should not exceed recommended dosages for the first day. Chronic Diarrhea Adults The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool until diarrhea is controlled, after which the dosage of loperamide hydrochloride should be reduced to meet individual requirements.

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

If clinical improvement is not observed after treatment with 16 mg per day for at least 10 days, symptoms are unlikely to be controlled by further administration. Loperamide hydrochloride administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment. Elderly No formal pharmacokinetic studies were conducted in elderly subjects.

However, there were no major differences reported in the drug disposition in elderly patients with diarrhea relative to young patients. No dose adjustment is required for the elderly. In general, elderly patients may be more susceptible to drug-associated effects of the QT interval.

Avoid loperamide hydrochloride in elderly patients taking drugs that can result in prolongation of the QT interval (for example, Class IA or III antiarrhythmics) or in patients with risk factors for Torsades de Pointes (see WARNINGS ). Renal Impairment No pharmacokinetic data are available in patients with renal impairment. Since the metabolites and the unchanged drug are mainly excreted in the feces, no dosage adjustment is required for patients with renal impairment (see PRECAUTIONS ).

Hepatic Impairment The pharmacokinetics of loperamide have not been studied in patients with hepatic impairment. Use loperamide hydrochloride with caution in such patients because the systemic exposure may be increased due to reduced metabolism (see PRECAUTIONS ).

⛔ Contraindications 101 words ▾

CONTRAINDICATIONS Loperamide hydrochloride is contraindicated in: pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions (see WARNINGS ). patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. patients with abdominal pain in the absence of diarrhea. patients with acute dysentery, which is characterized by blood in stools and high fever. patients with acute ulcerative colitis. patients with bacterial enterocolitis caused by invasive organisms including Salmonella , Shigella and Campylobacter . patients with pseudomembranous colitis (e.g., Clostridium difficle ) associated with the use of broad-spectrum antibiotics.

⚠️ Warnings ~2 min read ▾

WARNINGS Cardiac Adverse Reactions, Including Torsades de Pointes and Sudden Death Cases of prolongation of the QT/QTc interval, Torsades de Pointes, other ventricular arrhythmias, cardiac arrest, some resulting in death, have been reported in adults with use of higher than recommended doses per day of loperamide hydrochloride. Cases include patients who were abusing or misusing loperamide hydrochloride (see OVERDOSAGE and DRUG ABUSE AND DEPENDENCE ). Cases of syncope and ventricular tachycardia have been reported in adult patients receiving the recommended dosage of loperamide hydrochloride.

Some of these patients were taking other drugs or had other risk factors that may have increased their risk of cardiac adverse reactions. Additionally, postmarketing cases of cardiac arrest, syncope and respiratory depression have been reported in pediatric patients less than 2 years of age. Loperamide hydrochloride is contraindicated in pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions.

Avoid loperamide hydrochloride dosages higher than recommended in adults and pediatric patients 2 years of age and older due to the risk of serious cardiac adverse reactions (see DOSAGE AND ADMINISTRATION , OVERDOSAGE ) Avoid Loperamide Hydrochloride in: combination with others drugs or herbal products that are known to prolong the QT interval, including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, antipsychotics (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin) or any other drug known to prolong the QT interval (e.g., pentamidine, levomethadyl acetate, methadone) patients with risk factors for QT prolongation, including patients with congenital long QT syndrome, with a history of cardiac arrhythmias or other cardiac conditions, elderly patients and those with electrolyte abnormalities.

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

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

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

Variability in Pediatric Response Loperamide hydrochloride should be used with special caution in pediatric patients because of the greater variability of response in this age group. Dehydration, particularly in pediatric patients less than 6 years of age, may further influence the variability of response to loperamide hydrochloride. Loperamide hydrochloride is contraindicated in pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions.

🤒 Adverse Reactions ~3 min read ▾

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

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

2) Adverse events from 20 placebo-controlled studies in patients with chronic diarrhea The adverse events with an incidence of 1% or greater, which were reported at least as often in patients on loperamide hydrochloride as on placebo, are presented below in the table below. Chronic Diarrhea Loperamide Hydrochloride Placebo No. of treated patients 285 277 Gastrointestinal AE% Constipation 5.3% 0% Central and peripheral nervous system AE% Dizziness 1.4% 0.7% The adverse events with an incidence of 1% or greater, which were more frequently reported in patients on placebo than on loperamide hydrochloride were: nausea, vomiting, headache, meteorism, abdominal pain, abdominal cramp and colic.

3) Adverse events from seventy-six controlled and uncontrolled studies in patients with acute or chronic diarrhea The adverse events with an incidence of 1% or greater in patients from all studies are given in the table below. a. All patients in all studies, including those in which it was not specified if the adverse events occurred in patients with acute or chronic diarrhea. Acute Diarrhea Chronic Diarrhea All Studies a No. of treated patients 1,913 1,371 3,740 Gastrointestinal AE% Nausea Constipation Abdominal cramps 0.7% 1.6% 0.5% 3.2% 1.9% 3% 1.8% 1.7% 1.4% Postmarketing Experience The following adverse events have been reported: Cardiac disorders QT/QTc interval prolongation, Torsades de Pointes, other ventricular arrhythmias, cardiac arrest, syncope and death (see WARNINGS , OVERDOSAGE ).

Skin and subcutaneous tissue disorders Rash, pruritus, urticaria and angioedema and extremely rare cases bullous eruption including erythema multiforme, Stevens-Johnson syndrome and Toxic Epidermal Necrolysis have been reported with use of loperamide hydrochloride. Immune system disorders Isolated occurrences of allergic reactions and in some cases severe hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions have been reported with the use of loperamide hydrochloride. Gastrointestinal disorders Dry mouth, abdominal pain, distention or discomfort, nausea, vomiting, flatulence, dyspepsia, constipation, paralytic ileus, megacolon; including toxic megacolon (see CONTRAINDICATIONS , WARNINGS ).

Renal and urinary disorders Urinary retention Nervous system disorders Drowsiness, dizziness General disorders and administrative site conditions Tiredness A number of the adverse events reported during the clinical investigations and post-marketing experience with loperamide are frequent symptoms of the underlying diarrheal syndrome (abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation and flatulence). These symptoms are often difficult to distinguish from undesirable drug effects.

You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.

🆘 Overdosage ~2 min read ▾

OVERDOSAGE The use of higher than recommended loperamide hydrochloride doses may result in life-threatening cardiac, CNS and respiratory adverse reactions. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage. Cardiac Effects Symptoms Cases of overdosage with loperamide hydrochloride (chronic ingestion of doses ranging from 70 mg to 1,600 mg daily; 4 times to 100 times the recommended dose) have resulted in life-threatening cardiac adverse reactions, including QT/QTc and QRS interval prolongation, Torsades de Pointes, Brugada syndrome and other ventricular arrhythmias, syncope, cardiac arrest and death.

Cases include patients who were abusing (using supratherapeutic doses in place of opioids to induce euphoria) or misusing (taking higher than recommended doses to control diarrhea or to prevent opioid withdrawal) loperamide. The following are representative cases that included cardiac adverse reactions: 25 year old abused loperamide and presented to the hospital on multiple occasions with symptoms of syncope, nausea, vomiting, bradycardia, hypotensive shock. The patient also experienced ventricular tachycardia, a prolonged QTc of 527 ms and QRS interval of 170 ms, frequent premature ventricular contractions and subsequent cardiac arrest and death (elevated loperamide blood concentration of 32 ng/ml).

54 year old misused loperamide hydrochloride (up to 144 mg per day) as a self- treatment for chronic diarrhea for over 2 years. Signs of cardiac toxicity included syncope, prolonged QT of 500 ms sinus arrest with junctional escape rhythm and polymorphic ventricular tachycardia, which required cardioversion and implantable cardioverter-defibrillator (ICD) management. 26 year old, with prior opioid abuse, presented to the hospital with recurrent syncope and developed Torsades de Pointes requiring electrical cardioversion.

An ECG revealed a sinus rhythm with a heart rate of 85 bpm and a markedly prolonged QTc interval of greater than 700 ms. The patient reported ingesting 100 mg to 250 mg of loperamide hydrochloride with 400 mg of cimetidine daily for several months to simulate the euphoric sensation associated with opioids. Management Consider loperamide as a possible cause of cardiac arrhythmias in patients who may have a history of opioid abuse or recent ingestion of unknown drugs and in the differential diagnosis of unstable arrhythmias, prolonged QTc or QRS intervals and Torsades de Pointes.

If loperamide-induced cardiac toxicity is suspected, promptly discontinue the drug and initiate therapy to manage and prevent cardiac arrhythmias and serious outcomes. In many cases of loperamide overdosage, anti-arrhythmic medications (e.g., magnesium sulfate) were ineffective in resolving the arrhythmias and preventing further episodes of Torsades de Pointes. Electrical cardioversion and overdrive pacing and isoproterenol continuous infusion were reported to manage QTc prolongation in the setting of overdose.

Laboratory Testing Loperamide serum concentrations are not widely available or clinically useful to guide patient management. CNS and Respiratory Depression Symptoms Cases of loperamide overdose (including relative overdose due to hepatic dysfunction), may cause opioid toxic effects including CNS depression (e.g. altered mental status, stupor, coordination disorders, somnolence, miosis, muscular hypertonia, respiratory depression), hypotension, urinary retention and paralytic ileus. Pediatric patients may be more sensitive to CNS effects, including respiratory depression, than adults.

Management Loperamide non-cardiac arrhythmia overdosages should be treated as opioid overdosages. Naloxone may reverse the opioid-related toxicity, including CNS and respiratory depression and hypotension, associated with loperamide overdosage. In adults and pediatric patients, naloxone may be administered intravenously.

Appropriate doses of naloxone, via intranasal…

🧬 Clinical Pharmacology ~1 min read ▾

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

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

Tolerance to the antidiarrheal effect has not been observed. Pharmacokinetics Absorption Plasma concentrations of unchanged drug remain below 2 ng/mL after the intake of a 2 mg capsule of loperamide hydrochloride. Plasma loperamide concentrations are highest approximately 5 hours after administration of the capsule and 2.5 hours after the liquid.

The peak plasma concentrations of loperamide were similar for both formulations. Distribution Based on literature information, the plasma protein binding of loperamide is about 95%. Loperamide is a P-glycoprotein substrate.

Elimination The apparent elimination half-life of loperamide is 10.8 hours with a range of 9.1 hours to 14.4 hours. Elimination of loperamide mainly occurs by oxidative N-demethylation. Metabolism In vitro loperamide is metabolized mainly by cytochrome P450 (CYP450) isozymes, CYP2C8 and CYP3A4, to form- N-demethyl loperamide.

In an in vitro study quercetin (CYP2C8 inhibitor) and ketoconazole (CYP3A4 inhibitor) significantly inhibited the N-demethylation process by 40% and 90%, respectively. In addition, CYP2B6 and CYP2D6 appear to play a minor role in loperamide N-demethylation. Concomitant use of loperamide hydrochloride with inhibitors of CYP3A4 (e.g., itraconazole) or CYP2C8 (e.g., gemfibrozil) or inhibitors of P-glycoprotein (e.g., quinidine, ritonavir) can increase exposure to loperamide (see PRECAUTIONS, Drug Interactions ).

Excretion Excretion of the unchanged loperamide and its metabolites mainly occurs through the feces.

📦 How Supplied / Storage and Handling 161 words ▾

HOW SUPPLIED Loperamide hydrochloride capsules USP, 2 mg are white to off-white colored granular powder filled in size '3' hard gelatin capsule with cream opaque cap and cream opaque body printed with 1701 in black ink and are supplies as follows: NDC 72578-138-01 in bottle of 100 capsules with child resistant closure NDC 72578-138-05 in bottle of 500 capsules NDC 72578-138-77 in unit-dose blister cartons of 100 capsules (10 x 10 unit-dose) Store at 20°C to 25°C (68ºF to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please address medical inquiries to, [email protected] or Tel.: 1-888-304-5011. Trademarks listed are property of their respective owners. Manufactured by: Zydus Lifesciences Ltd.

Ahmedabad, India Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 Rev: 04/23

📋 Description 89 words ▾

DESCRIPTION Loperamide hydrochloride USP, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl- a,a- diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use. Loperamide hydrochloride is available in 2 mg capsules. Loperamide hydrochloride capsules, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate microcrystalline cellulose, povidone k-30 and sodium starch glycolate.

The capsule shell contains gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulfate, titanium dioxide and water. The capsule shell is imprinted with black ink and contains following inactive ingredients: black iron oxide, potassium hydroxide and shellac. Image

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