1. Home
  2. Labeler Index
  3. Dental Technologies, Inc.
  4. 55346-0943
  5. NDC Package Code: 55346-0943-1 Alpha-pro

NDC Package 55346-0943-1 Alpha-pro

Sodium Fluoride And Hydrofluoric Acid Gel Dental - 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:
55346-0943-1
Package Description:
497 g in 1 BOTTLE
Product Code:
55346-0943
Proprietary Name:
Alpha-pro
Non-Proprietary Name:
Sodium Fluoride And Hydrofluoric Acid
Substance Name:
Hydrofluoric Acid; Sodium Fluoride
Usage Information:
Topical application of APF gel is indicated in the prevention of dental caries. This treatment is normally used two times per year and should not exceed four times per year.
11-Digit NDC Billing Format:
55346094301
NDC to RxNorm Crosswalk:
  • RxCUI: 1297381 - hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral Gel
  • RxCUI: 1297381 - hydrofluoric acid 0.01 MG/MG / phosphoric acid 0.0112 MG/MG / sodium fluoride 0.018 MG/MG Oral Gel
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dental Technologies, Inc.
    Dosage Form:
    Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
    Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • HYDROFLUORIC ACID 4.4 mg/g
  • SODIUM FLUORIDE 7.9 mg/g
    • Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date:
    04-01-2013
    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.

    Frequently Asked Questions

    What is NDC 55346-0943-1?

    The NDC Packaged Code 55346-0943-1 is assigned to a package of 497 g in 1 bottle of Alpha-pro, a human prescription drug labeled by Dental Technologies, Inc.. The product's dosage form is gel and is administered via dental form.

    Is NDC 55346-0943 included in the NDC Directory?

    Yes, Alpha-pro with product code 55346-0943 is active and included in the NDC Directory. The product was first marketed by Dental Technologies, Inc. on April 01, 2013 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 55346-0943-1?

    The 11-digit format is 55346094301. 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 5-4-1 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
    5-4-155346-0943-15-4-255346-0943-01