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  5. NDC Package Code: 44038-0325-1 Hismile

NDC Package 44038-0325-1 Hismile

Sodium Fluoride 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:
44038-0325-1
Package Description:
60 g in 1 BOTTLE, PUMP
Product Code:
44038-0325
Proprietary Name:
Hismile
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal of at least twice a day, or use as directed by a dentist of doctor.Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).Supervise children as necessary until capable of using without supervision.Children under 2 years of age: Consult a dentist or doctor.
11-Digit NDC Billing Format:
44038032501
NDC to RxNorm Crosswalk:
Product Type:
Human Otc Drug
Labeler Name:
Accupac Llc
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):
SODIUM FLUORIDE .243 g/100g
Sample Package:
No
FDA Application Number:
M021
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
07-23-2024
Listing Expiration Date:
12-31-2025
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 44038-0325-1?

The NDC Packaged Code 44038-0325-1 is assigned to a package of 60 g in 1 bottle, pump of Hismile, a human over the counter drug labeled by Accupac Llc. The product's dosage form is gel and is administered via dental form.

Is NDC 44038-0325 included in the NDC Directory?

Yes, Hismile with product code 44038-0325 is active and included in the NDC Directory. The product was first marketed by Accupac Llc on July 23, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 44038-0325-1?

The 11-digit format is 44038032501. 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
5-4-144038-0325-15-4-244038-0325-01