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  5. NDC Package Code: 58602-815-76 Loperamide Hydrochloride And Simethicone

NDC Package 58602-815-76 Loperamide Hydrochloride And Simethicone

Tablet 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:
58602-815-76
Package Description:
4 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK
Product Code:
58602-815
Proprietary Name:
Loperamide Hydrochloride And Simethicone
Non-Proprietary Name:
Loperamide Hydrochloride And 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 to 11 years (60 to 95 lbs)1 caplet after the first loose stool; ½ capletafter each subsequent loose stool; but no more than 3 caplets in 24 hourschildren 6 to 8 years (48 to 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 to 5 years (34 to 47 lbs)ask a doctorchildren under 2 years (up to 33 lbs)do not use
11-Digit NDC Billing Format:
58602081576
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
4 EA
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:
    Aurohealth Llc
    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:
    ANDA211059
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-14-2020
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    58602-815-741 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK
    58602-815-752 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK
    58602-815-803 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58602-815-76?

    The NDC Packaged Code 58602-815-76 is assigned to a package of 4 blister pack in 1 carton / 6 tablet in 1 blister pack of Loperamide Hydrochloride And Simethicone, a human over the counter drug labeled by Aurohealth Llc. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package.

    Is NDC 58602-815 included in the NDC Directory?

    Yes, Loperamide Hydrochloride And Simethicone with product code 58602-815 is active and included in the NDC Directory. The product was first marketed by Aurohealth Llc on December 14, 2020 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 NDC billing unit for package 58602-815-76?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 4.

    What is the 11-digit format for NDC 58602-815-76?

    The 11-digit format is 58602081576. 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
    5-3-258602-815-765-4-258602-0815-76