NDC Package 69618-033-01 Simethicone 80 Mg

Simethicone Tablet, Chewable Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
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:

69618-033-01

Package Description:

100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

Product Code:

69618-033

Proprietary Name:

Simethicone 80 Mg

Non-Proprietary Name:

Simethicone

Substance Name:

Dimethicone

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.

11-Digit NDC Billing Format:

69618003301

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

100 EA

NDC to RxNorm Crosswalk:

RxCUI: 314216 - simethicone 80 MG Chewable Tablet

Product Type:

Human Otc Drug

Labeler Name:

Reliable 1 Laboratories 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):

DIMETHICONE 80 mg/1

Pharmacologic Class(es):

Skin Barrier Activity - [PE] (Physiologic Effect)

Sample Package:

FDA Application Number:

part332

Marketing Category:

OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.

Start Marketing Date:

04-24-2018

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

69618 - Reliable 1 Laboratories Llc
- 69618-033 - Simethicone 80 Mg
  - 69618-033-01 - 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

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.

Frequently Asked Questions

What is NDC 69618-033-01?

The NDC Packaged Code 69618-033-01 is assigned to a package of 100 tablet, chewable in 1 bottle, plastic of Simethicone 80 Mg, a human over the counter drug labeled by Reliable 1 Laboratories Llc. The product's dosage form is tablet, chewable and is administered via oral form.

Is NDC 69618-033 included in the NDC Directory?

Yes, Simethicone 80 Mg with product code 69618-033 is active and included in the NDC Directory. The product was first marketed by Reliable 1 Laboratories Llc on April 24, 2018 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 69618-033-01?

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 100.

What is the 11-digit format for NDC 69618-033-01?

The 11-digit format is 69618003301. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	69618-033-01	5-4-2	69618-0033-01

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