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  5. NDC Package Code: 36800-616-63 Topcare Dual Action Complete

NDC Package 36800-616-63 Topcare Dual Action Complete

Famotidine,Calcium Carbonate And Magnesium Hydroxide Tablet, Chewable 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:
36800-616-63
Package Description:
25 TABLET, CHEWABLE in 1 BOTTLE
Product Code:
36800-616
Proprietary Name:
Topcare Dual Action Complete
Non-Proprietary Name:
Famotidine, Calcium Carbonate And Magnesium Hydroxide
Substance Name:
Calcium Carbonate; Famotidine; Magnesium Hydroxide
Usage Information:
•adults and children 12 years and over:•do not swallow tablet whole: chew completely•to relieve symptoms, chew 1 tablet before swallowing•do not use more than 2 chewable tablets in 24 hours•children under 12 years: ask a doctor
11-Digit NDC Billing Format:
36800061663
NDC to RxNorm Crosswalk:
  • RxCUI: 283641 - famotidine 10 MG / calcium carbonate 800 MG / magnesium hydroxide 165 MG Chewable Tablet
  • RxCUI: 283641 - calcium carbonate 800 MG / famotidine 10 MG / magnesium hydroxide 165 MG Chewable Tablet
  • RxCUI: 283641 - calcium carbonate 800 MG / famotidine 10 MG / milk of magnesia 165 MG Chewable Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Topco Associates Llc
    Dosage Form:
    Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CALCIUM CARBONATE 800 mg/1
  • FAMOTIDINE 10 mg/1
  • MAGNESIUM HYDROXIDE 165 mg/1
    • Pharmacologic Class(es):
  • Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
  • Histamine H2 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-2 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA077355
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-29-2016
    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
    36800-616-7150 TABLET, CHEWABLE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 36800-616-63?

    The NDC Packaged Code 36800-616-63 is assigned to a package of 25 tablet, chewable in 1 bottle of Topcare Dual Action Complete, a human over the counter drug labeled by Topco Associates Llc. The product's dosage form is tablet, chewable and is administered via oral form.

    Is NDC 36800-616 included in the NDC Directory?

    Yes, Topcare Dual Action Complete with product code 36800-616 is active and included in the NDC Directory. The product was first marketed by Topco Associates Llc on February 29, 2016 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 36800-616-63?

    The 11-digit format is 36800061663. 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
    5-3-236800-616-635-4-236800-0616-63