NDC Package 80425-0422-3 Ibuprofen And Famotidine

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
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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:

80425-0422-3

Package Description:

90 TABLET, FILM COATED in 1 BOTTLE

Product Code:

80425-0422

Proprietary Name:

Ibuprofen And Famotidine

Non-Proprietary Name:

Ibuprofen And Famotidine

Substance Name:

Famotidine; Ibuprofen

Usage Information:

Ibuprofen and famotidine tablet, a combination of the NSAID ibuprofen and the histamine H 2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies ( 14), Use in Specific Populations ( 8.5)] .

11-Digit NDC Billing Format:

80425042203

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

90 EA

NDC to RxNorm Crosswalk:

RxCUI: 1100066 - ibuprofen 800 MG / famotidine 26.6 MG Oral Tablet
RxCUI: 1100066 - famotidine 26.6 MG / ibuprofen 800 MG Oral Tablet

Product Type:

Human Prescription Drug

Labeler Name:

Advanced Rx Of Tennessee, Llc

Dosage Form:

Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

Pharmacologic Class(es):

Sample Package:

FDA Application Number:

ANDA211890

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

07-16-2024

Listing Expiration Date:

12-31-2025

Exclude Flag:

Code Structure:

80425 - Advanced Rx Of Tennessee, Llc
- 80425-0422 - Ibuprofen And Famotidine
  - 80425-0422-3 - 90 TABLET, FILM COATED in 1 BOTTLE

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 Code	Package Description
80425-0422-1	30 TABLET, FILM COATED in 1 BOTTLE
80425-0422-2	60 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 80425-0422-3?

The NDC Packaged Code 80425-0422-3 is assigned to a package of 90 tablet, film coated in 1 bottle of Ibuprofen And Famotidine, a human prescription drug labeled by Advanced Rx Of Tennessee, Llc. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package.

Is NDC 80425-0422 included in the NDC Directory?

Yes, Ibuprofen And Famotidine with product code 80425-0422 is active and included in the NDC Directory. The product was first marketed by Advanced Rx Of Tennessee, Llc on July 16, 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 NDC billing unit for package 80425-0422-3?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 90.

What is the 11-digit format for NDC 80425-0422-3?

The 11-digit format is 80425042203. 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	80425-0422-3	5-4-2	80425-0422-03

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