NDC Package 48878-4061-3 Omni

Stannous Fluoride Gel 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:

48878-4061-3

Package Description:

1 TUBE in 1 BOX / 121.9 g in 1 TUBE

Product Code:

48878-4061

Proprietary Name:

Omni

Non-Proprietary Name:

Stannous Fluoride

Substance Name:

Stannous Fluoride

Usage Information:

Adults and children 6 years of age and older: Use a pea-sized (.25g) dose once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.

11-Digit NDC Billing Format:

48878406103

Billing Unit:

GM - Billing unit of "gram" is used when a product is measured by its weight.

NDC to RxNorm Crosswalk:

121.9 GM

Product Type:

Human Otc Drug

Labeler Name:

Solventum Us Opco 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):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

STANNOUS FLUORIDE .969 mg/g

Sample Package:

FDA Application Number:

M021

Marketing Category:

OTC MONOGRAPH DRUG -

Start Marketing Date:

02-01-1998

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

48878 - Solventum Us Opco Llc
- 48878-4061 - Omni
  - 48878-4061-3 - 1 TUBE in 1 BOX / 121.9 g in 1 TUBE

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 48878-4061-3?

The NDC Packaged Code 48878-4061-3 is assigned to a package of 1 tube in 1 box / 121.9 g in 1 tube of Omni, a human over the counter drug labeled by Solventum Us Opco Llc. The product's dosage form is gel and is administered via oral form.This product is billed per "GM" gram and contains an estimated amount of 121.9 billable units per package.

Is NDC 48878-4061 included in the NDC Directory?

Yes, Omni with product code 48878-4061 is active and included in the NDC Directory. The product was first marketed by Solventum Us Opco Llc on February 01, 1998 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 NDC billing unit for package 48878-4061-3?

The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 121.9.

What is the 11-digit format for NDC 48878-4061-3?

The 11-digit format is 48878406103. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	48878-4061-3	5-4-2	48878-4061-03

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