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  5. NDC Package Code: 53329-664-57 Loperamide Hydrochloride

NDC Package 53329-664-57 Loperamide Hydrochloride

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

Table of Contents

    1. Package Information
    2. 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:
53329-664-57
Package Description:
12 TABLET in 1 BLISTER PACK
Product Code:
53329-664
Proprietary Name:
Loperamide Hydrochloride
Non-Proprietary Name:
Loperamide Hydrochloride
Substance Name:
Loperamide Hydrochloride
Usage Information:
Drink plenty of clear fluids to help prevent dehydration caused by diarrheafind right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children under 6 years (up to 47 lbs) ask a doctor
11-Digit NDC Billing Format:
53329066457
NDC to RxNorm Crosswalk:
  • RxCUI: 978010 - loperamide HCl 2 MG Oral Tablet
  • RxCUI: 978010 - loperamide hydrochloride 2 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Medline Industries, Lp
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    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:
    ANDA074091
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-01-1993
    Listing Expiration Date:
    12-31-2024
    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.

    Frequently Asked Questions

    What is NDC 53329-664-57?

    The NDC Packaged Code 53329-664-57 is assigned to a package of 12 tablet in 1 blister pack of Loperamide Hydrochloride, a human over the counter drug labeled by Medline Industries, Lp. The product's dosage form is tablet and is administered via oral form.

    Is NDC 53329-664 included in the NDC Directory?

    Yes, Loperamide Hydrochloride with product code 53329-664 is active and included in the NDC Directory. The product was first marketed by Medline Industries, Lp on February 01, 1993 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53329-664-57?

    The 11-digit format is 53329066457. 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 5-3-2 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
    5-3-253329-664-575-4-253329-0664-57