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  5. NDC Package Code: 53041-263-50 Loperamide Hydrochloride, Simethicone

NDC Package 53041-263-50 Loperamide Hydrochloride, Simethicone

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:
53041-263-50
Package Description:
1 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK
Product Code:
53041-263
Proprietary Name:
Loperamide Hydrochloride, Simethicone
Non-Proprietary Name:
Loperamide Hydrochloride, Simethicone
Substance Name:
Dimethicone; Loperamide Hydrochloride
Usage Information:
Drink plenty of clear fluids to help prevent dehydration caused by diarrheatake only on an empty stomach (1 hour before or 2 hours after a meal)take with a full (8 oz.) glass of waterfind right dose on chart below. If possible, use weight to dose; otherwise, use age.adults and children 12 years and over2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hourschildren 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 hourschildren 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 hourschildren 2-5 years (34 to 47 lbs)ask a doctorchildren under 2 years (up to 33 lbs)do not use
11-Digit NDC Billing Format:
53041026350
NDC to RxNorm Crosswalk:
  • RxCUI: 978001 - loperamide HCl 2 MG / simethicone 125 MG Oral Tablet
  • RxCUI: 978001 - loperamide hydrochloride 2 MG / simethicone 125 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Guardian Drug Company
    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):
  • DIMETHICONE 125 mg/1
  • LOPERAMIDE HYDROCHLORIDE 2 mg/1
    • Pharmacologic Class(es):
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
  • Opioid Agonists - [MoA] (Mechanism of Action)
  • Skin Barrier Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA214541
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-01-2021
    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 53041-263-50?

    The NDC Packaged Code 53041-263-50 is assigned to a package of 1 blister pack in 1 carton / 6 tablet in 1 blister pack of Loperamide Hydrochloride, Simethicone, a human over the counter drug labeled by Guardian Drug Company. The product's dosage form is tablet and is administered via oral form.

    Is NDC 53041-263 included in the NDC Directory?

    Yes, Loperamide Hydrochloride, Simethicone with product code 53041-263 is active and included in the NDC Directory. The product was first marketed by Guardian Drug Company on June 01, 2021 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 53041-263-50?

    The 11-digit format is 53041026350. 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
    5-3-253041-263-505-4-253041-0263-50