Gelusil Tablet, Chewable
NDC Package 65197-300-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Gelusil (alumina, magnesia, simethicone) tablets is •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. This formulation utilizes a tablet, chewable delivery system. Marketed by Wellspring Pharmaceutical Corporation, this product is identified by NDC 65197-300 and is authorized under FDA application M001.

Identification & Billing

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
11-Digit Billing Format
65197030010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
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

Clinical Specifications

Proprietary Name
Gelusil
Non-Proprietary Name
Alumina, Magnesia, Simethicone
Substance Name
Aluminum Hydroxide; Dimethicone, Unspecified; Magnesium Hydroxide; Silicon Dioxide
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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

Regulatory & Marketing

Labeler Name
Wellspring Pharmaceutical Corporation
Product Type
Human Otc Drug
FDA Application #
M001
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-24-2008
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65197-300). Click a package code to view its specific billing and regulatory data.

65197-300-11
100 TABLET, CHEWABLE in 1 BOTTLE
65197-300-20
2 BLISTER PACK in 1 CARTON / 10 TABLET, CHEWABLE in 1 BLISTER PACK

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65197-300-10 identifies a specific commercial 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. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. This tablet, chewable is formulated for oral use and contains aluminum hydroxide; dimethicone, unspecified; magnesium hydroxide; silicon dioxide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Wellspring Pharmaceutical Corporation on September 24, 2008. The current certification is valid through December 31, 2026.

How is this Wellspring Pharmaceutical Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65197030010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
65197-300-10
11-Digit CMS (5-4-2)
65197-0300-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.