Loperamide Hydrochloride Capsule
NDC Package 60468-005-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Loperamide Hydrochloride capsules is (loperamide hydrochloride) is 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. This formulation utilizes a capsule delivery system. Marketed by Allphamed Pharbil Arzneimittel Gmbh, this product is identified by NDC 60468-005 and is authorized under FDA application ANDA215001.

Identification & Billing

NDC Package Code
60468-005-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
60468-005
11-Digit Billing Format
60468000501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Loperamide Hydrochloride
Non-Proprietary Name
Loperamide Hydrochloride
Substance Name
Loperamide Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LOPERAMIDE HYDROCHLORIDE 2 mg/1
Pharmacologic Class
Usage Information
Loperamide Hydrochloride Capsules (loperamide hydrochloride) is 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 is also indicated for reducing the volume of discharge from ileostomies.

Regulatory & Marketing

Labeler Name
Allphamed Pharbil Arzneimittel Gmbh
Product Type
Human Prescription Drug
FDA Application #
ANDA215001
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-25-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (60468-005). Click a package code to view its specific billing and regulatory data.

60468-005-05
500 CAPSULE in 1 BOTTLE
60468-005-30
30 CAPSULE in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 60468-005-01 identifies a specific commercial package of 100 capsule in 1 bottle of Loperamide Hydrochloride, a human prescription drug labeled by Allphamed Pharbil Arzneimittel Gmbh. This capsule is formulated for oral use and contains loperamide hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Allphamed Pharbil Arzneimittel Gmbh on September 25, 2020. The current certification is valid through December 31, 2026.

How is this Allphamed Pharbil Arzneimittel Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60468000501. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
60468-005-01
11-Digit CMS (5-4-2)
60468-0005-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.