Ibuprofen And Famotidine Tablet
NDC Package 80425-0384-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Ibuprofen And Famotidine tablets is 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. This formulation utilizes a tablet delivery system. Marketed by Advanced Rx Pharmacy Of Tennessee, Llc, this product is identified by NDC 80425-0384 and is authorized under FDA application ANDA216814.

Identification & Billing

NDC Package Code
80425-0384-2
Package Description
60 TABLET in 1 BOTTLE
Product Code
80425-0384
11-Digit Billing Format
80425038402
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ibuprofen And Famotidine
Non-Proprietary Name
Ibuprofen And Famotidine
Substance Name
Famotidine; Ibuprofen
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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)].

Regulatory & Marketing

Labeler Name
Advanced Rx Pharmacy Of Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA216814
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-23-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (80425-0384). Click a package code to view its specific billing and regulatory data.

80425-0384-1
30 TABLET in 1 BOTTLE
80425-0384-3
90 TABLET in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 80425-0384-2 identifies a specific commercial package of 60 tablet in 1 bottle of Ibuprofen And Famotidine, a human prescription drug labeled by Advanced Rx Pharmacy Of Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet is formulated for oral use and contains famotidine; ibuprofen as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Advanced Rx Pharmacy Of Tennessee, Llc on April 23, 2024. The current certification is valid through December 31, 2026.

How is this Advanced Rx Pharmacy Of Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80425038402. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
80425-0384-2
11-Digit CMS (5-4-2)
80425-0384-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.