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  5. NDC Package Code: 70275-201-16 Pro-sys

NDC Package 70275-201-16 Pro-sys

Oral Wound Cleanser Liquid Buccal - 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:
70275-201-16
Package Description:
473 mL in 1 BOTTLE
Product Code:
70275-201
Proprietary Name:
Pro-sys
Non-Proprietary Name:
Oral Wound Cleanser
Substance Name:
Hydrogen Peroxide
Usage Information:
• Adults and children 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the affected area for at least 1 minute, then spit out. • Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician. • Children under 12 years of age should be supervised in the use of the product. • Children under 2 years of age: Consult a dentist or physician. • Adults and children 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the affected area for at least 1 minute, then spit out. • Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician. • Children under 12 years of age should be supervised in the use of the product. • Children under 2 years of age: Consult a dentist or physician.
11-Digit NDC Billing Format:
70275020116
NDC to RxNorm Crosswalk:
  • RxCUI: 205336 - hydrogen peroxide 1.5 % Mucous Membrane Topical Solution
  • RxCUI: 205336 - hydrogen peroxide 15 MG/ML Mucous Membrane Topical Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Forward Science Technologies Llc
    Dosage Form:
    Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
    Administration Route(s):
  • Buccal - Administration directed toward the cheek, generally from within the mouth.
    • Active Ingredient(s):
  • HYDROGEN PEROXIDE 15 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    part356
    Marketing Category:
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date:
    05-16-2022
    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
    70275-201-283785 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70275-201-16?

    The NDC Packaged Code 70275-201-16 is assigned to a package of 473 ml in 1 bottle of Pro-sys, a human over the counter drug labeled by Forward Science Technologies Llc. The product's dosage form is liquid and is administered via buccal form.

    Is NDC 70275-201 included in the NDC Directory?

    Yes, Pro-sys with product code 70275-201 is active and included in the NDC Directory. The product was first marketed by Forward Science Technologies Llc on May 16, 2022 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 11-digit format for NDC 70275-201-16?

    The 11-digit format is 70275020116. 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
    5-3-270275-201-165-4-270275-0201-16