Simethicone 80mg Tablet, Chewable
NDC Package 77333-812-10

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

Package Information

Simethicone 80mg (simethicone) tablets is a medication used to relieve symptoms of extra gas caused by air swallowing or certain foods/infant formulas. This formulation utilizes a tablet, chewable delivery system. Marketed by Gendose Pharmaceuticals, Llc, this product is identified by NDC 77333-812 and is authorized under FDA application M002.

Identification & Billing

NDC Package Code
77333-812-10
Package Description
100 BLISTER PACK in 1 BOX / 1 TABLET, CHEWABLE in 1 BLISTER PACK (77333-812-25)
Product Code
77333-812
11-Digit Billing Format
77333081210
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
RxCUI: 314216 - simethicone 80 MG Chewable Tablet

Clinical Specifications

Proprietary Name
Simethicone 80mg
Non-Proprietary Name
Simethicone
Substance Name
Dimethicone
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)
DIMETHICONE 80 mg/1
Pharmacologic Class
Skin Barrier Activity - [PE] (Physiologic Effect)
Usage Information
This product is used to relieve symptoms of extra gas caused by air swallowing or certain foods/infant formulas. Simethicone helps break up gas bubbles in the gut.

Regulatory & Marketing

Labeler Name
Gendose Pharmaceuticals, Llc
Product Type
Human Otc Drug
FDA Application #
M002
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-02-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 77333-812-10 identifies a specific commercial package of 100 blister pack in 1 box / 1 tablet, chewable in 1 blister pack (77333-812-25) of Simethicone 80mg, a human over the counter drug labeled by Gendose Pharmaceuticals, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet, chewable is formulated for oral use and contains dimethicone 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 Gendose Pharmaceuticals, Llc on September 02, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to relieve symptoms of extra gas caused by air swallowing or certain foods/infant formulas. Simethicone helps break up gas bubbles in the gut.

How is this Gendose Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 77333081210. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
77333-812-10
11-Digit CMS (5-4-2)
77333-0812-10

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