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  5. NDC Package Code: 55319-325-01 Infants Gas Relief

NDC Package 55319-325-01 Infants Gas Relief

Simethicone Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
55319-325-01
Package Description:
1 BOTTLE in 1 BOX / 30 mL in 1 BOTTLE
Product Code:
55319-325
Proprietary Name:
Infants Gas Relief
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:
55319032501
NDC to RxNorm Crosswalk:
  • RxCUI: 198857 - simethicone 20 MG in 0.3 mL Oral Suspension
  • RxCUI: 198857 - simethicone 66.7 MG/ML Oral Suspension
  • RxCUI: 198857 - simethicone 20 MG per 0.3 ML Oral Suspension
  • RxCUI: 198857 - simethicone 40 MG per 0.6 ML Oral Suspension
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Family Dollar (family Wellness)
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DIMETHICONE 20 mg/.3mL
    • Pharmacologic Class(es):
  • Skin Barrier Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    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:
    02-28-2017
    End Marketing Date:
    04-26-2024
    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.

    Frequently Asked Questions

    What is NDC 55319-325-01?

    The NDC Packaged Code 55319-325-01 is assigned to a package of 1 bottle in 1 box / 30 ml in 1 bottle of Infants Gas Relief, a human over the counter drug labeled by Family Dollar (family Wellness). The product's dosage form is suspension and is administered via oral form.

    Is NDC 55319-325 included in the NDC Directory?

    Yes, Infants Gas Relief with product code 55319-325 is active and included in the NDC Directory. The product was first marketed by Family Dollar (family Wellness) on February 28, 2017.

    What is the 11-digit format for NDC 55319-325-01?

    The 11-digit format is 55319032501. 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
    5-3-255319-325-015-4-255319-0325-01