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  5. NDC Package Code: 70518-0313-0 Loperamide Hydrochloride

NDC Package 70518-0313-0 Loperamide Hydrochloride

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
70518-0313-0
Package Description:
30 CAPSULE in 1 BLISTER PACK
Product Code:
70518-0313
Proprietary Name:
Loperamide Hydrochloride
Non-Proprietary Name:
Loperamide Hydrochloride
Substance Name:
Loperamide Hydrochloride
Usage Information:
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.
11-Digit NDC Billing Format:
70518031300
NDC to RxNorm Crosswalk:
  • RxCUI: 978006 - loperamide HCl 2 MG Oral Capsule
  • RxCUI: 978006 - loperamide hydrochloride 2 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Remedyrepack Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • LOPERAMIDE HYDROCHLORIDE 2 mg/1
    • Pharmacologic Class(es):
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
  • Opioid Agonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA072741
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-13-2017
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    70518-0313-115 CAPSULE in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70518-0313-0?

    The NDC Packaged Code 70518-0313-0 is assigned to a package of 30 capsule in 1 blister pack of Loperamide Hydrochloride, a human prescription drug labeled by Remedyrepack Inc.. The product's dosage form is capsule and is administered via oral form.

    Is NDC 70518-0313 included in the NDC Directory?

    Yes, Loperamide Hydrochloride with product code 70518-0313 is active and included in the NDC Directory. The product was first marketed by Remedyrepack Inc. on March 13, 2017 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70518-0313-0?

    The 11-digit format is 70518031300. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-170518-0313-05-4-270518-0313-00