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  5. NDC Package Code: 65197-300-10 Gelusil

NDC Package 65197-300-10 Gelusil

Alumina,Magnesia,Simethicone 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:
65197-300-10
Package Description:
10 BLISTER PACK in 1 CARTON / 10 TABLET, CHEWABLE in 1 BLISTER PACK
Product Code:
65197-300
Proprietary Name:
Gelusil
Non-Proprietary Name:
Alumina, Magnesia, Simethicone
Substance Name:
Aluminum Hydroxide; Dimethicone; Magnesium Hydroxide; Silicon Dioxide
Usage Information:
•Adults and children 12 years of age and older: Chew 2 to 4 tablets.  Repeat hourly if symptoms return, or as directed by a physician •Children under 12 of age: ask a doctor•Do not take more than 12 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician
11-Digit NDC Billing Format:
65197030010
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
10 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 211633 - Gelusil Antacid & Anti-Gas 200 MG / 200 MG / 25 MG Chewable Tablet
  • RxCUI: 211633 - aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable Tablet [Gelusil]
  • RxCUI: 211633 - Gelusil (aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG) Chewable Tablet
  • RxCUI: 211633 - Gelusil Antacid & Anti-Gas (aluminum hydroxide 200 MG / milk of magnesia 200 MG / simethicone 25 MG) Chewable Tablet
  • RxCUI: 307747 - aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Wellspring Pharmaceutical Corporation
    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):
  • ALUMINUM HYDROXIDE 200 mg/1
  • DIMETHICONE 24 mg/1
  • MAGNESIUM HYDROXIDE 200 mg/1
  • SILICON DIOXIDE 1 mg/1
    • Pharmacologic Class(es):
  • Calculi Dissolution Agent - [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)
  • Skin Barrier Activity - [PE] (Physiologic Effect)
  • Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    M001
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    09-24-2008
    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
    65197-300-11100 TABLET, CHEWABLE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65197-300-10?

    The NDC Packaged Code 65197-300-10 is assigned to a package of 10 blister pack in 1 carton / 10 tablet, chewable in 1 blister pack of Gelusil, a human over the counter drug labeled by Wellspring Pharmaceutical Corporation. The product's dosage form is tablet, chewable and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package.

    Is NDC 65197-300 included in the NDC Directory?

    Yes, Gelusil with product code 65197-300 is active and included in the NDC Directory. The product was first marketed by Wellspring Pharmaceutical Corporation on September 24, 2008 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 65197-300-10?

    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 10.

    What is the 11-digit format for NDC 65197-300-10?

    The 11-digit format is 65197030010. 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
    5-3-265197-300-105-4-265197-0300-10