Quick answers
- What is Loperamide hydrochloride used for?
- The FDA-approved label (Loperamide HCl, Direct_Rx, August 25, 2026) says: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Loperamide hydrochloride have a boxed warning?
- Yes. The FDA label for Loperamide HCl has a boxed warning (“WARNING: TORSADES DE POINTES AND SUDDEN DEATH”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Loperamide hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Loperamide hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Loperamide hydrochloride?
- 27 companies list prescription products of Loperamide hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, NuCare Pharmaceuticals, Inc. and Aphena Pharma Solutions - Tennessee, LLC.
What Loperamide hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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.
— FDA label: Loperamide HCl, Direct_Rx, effective August 25, 2026. Read the full label on DailyMed →
The FDA has 42 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: TORSADES DE POINTES AND SUDDEN DEATH
. Read it on the full label →
40 of 42 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 43 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| loperamide hydrochloride 2 mg capsule | Generic | $0.0578 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack6 products
- NuCare Pharmaceuticals, Inc.5 products
- Aphena Pharma Solutions - Tennessee, LLC4 products
- Cardinal Health 107, LLC3 products
- A-S Medication Solutions2 products
- PD-Rx Pharmaceuticals, Inc.2 products
- American Health Packaging1 product
- Mylan Institutional Inc.1 product
- Aurobindo Pharma Limited1 product
- allphamed Pharbil Arzneimittel GmbH1 product
- NorthStar Rx LLC1 product
- Edenbridge Pharmaceuticals LLC.1 product
- Safecor Health LLC1 product
- Coupler LLC1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Major Pharmaceuticals1 product
- Golden State Medical Supply, Inc.1 product
- Zydus Lifesciences Limited1 product
- Redpharm Drug1 product
- Bionpharma Inc.1 product
- Remedyrepack Inc.1 product
- Advagen Pharma Ltd1 product
- Teva Pharmaceuticals USA, Inc.1 product
- Mylan Pharmaceuticals Inc.1 product
- AvPAK1 product
- Direct_Rx1 product
- Viona Pharmaceuticals Inc1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (7)
- ANDA072741Mylan · September 18, 1991
- ANDA073192Teva · April 30, 1992
- ANDA215001Edenbridge Pharms · October 6, 2021
- ANDA215579Bionpharma · October 22, 2021
- ANDA216876Rubicon Research · January 26, 2023
- ANDA217471Zydus Lifesciences · March 23, 2023
- ANDA218122Aurobindo Pharma Ltd · September 5, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 13, 2022 · Class II · Terminated · D-1092-2022
cGMP deviations: Temperature abuse
Loperamide Hydrochloride capsules, USP, 2 mg, 100-count bottle, Rx only, MFG: Mylan Pharma, NDC 0378-2100-01 — Mckesson Medical-Surgical Inc. Corporate Office
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 978006 |
|---|---|
| SPL set ID of the quoted label | 59e1c4cf-17cc-13c9-e063-6294a90af61c |
| FDA labels (SPL) | 42 |
| FDA applications | 7 ANDA |
| Active ingredients (FDA) | LOPERAMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Loperamide HCl, Direct_Rx, effective August 25, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →