Acetaminophen 250 Mg And Ibuprofen 125 Mg Tablet, Film Coated
NDC Package 25000-080-07

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

Acetaminophen 250 Mg And Ibuprofen 125 Mg (acetaminophen 250 mg and ibuprofen 125 mg tablets) tablets is • do not take more than directedadults and children 12 years and over   • take 2 caplets every 8 hours while symptoms persistchildren under 12 years • ask a doctor • do not take more than 6 caplets in 24 hours, unless directed by a doctor. This formulation utilizes a tablet, film coated delivery system. Marketed by Marksans Pharma Limited, this product is identified by NDC 25000-080 and is authorized under FDA application ANDA216994.

Identification & Billing

NDC Package Code
25000-080-07
Package Description
1 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE
Product Code
25000-080
11-Digit Billing Format
25000008007
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acetaminophen 250 Mg And Ibuprofen 125 Mg
Non-Proprietary Name
Acetaminophen 250 Mg And Ibuprofen 125 Mg Tablets
Substance Name
Acetaminophen; Ibuprofen
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
• do not take more than directedadults and children 12 years and over   • take 2 caplets every 8 hours while symptoms persistchildren under 12 years • ask a doctor • do not take more than 6 caplets in 24 hours, unless directed by a doctor

Regulatory & Marketing

Labeler Name
Marksans Pharma Limited
Product Type
Human Otc Drug
FDA Application #
ANDA216994
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-11-2023
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 (25000-080). Click a package code to view its specific billing and regulatory data.

25000-080-72
1 BOTTLE in 1 CARTON / 18 TABLET, FILM COATED in 1 BOTTLE
25000-080-74
288 TABLET, FILM COATED 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 25000-080-07 identifies a specific commercial package of 1 bottle in 1 carton / 90 tablet, film coated in 1 bottle of Acetaminophen 250 Mg And Ibuprofen 125 Mg, a human over the counter drug labeled by Marksans Pharma Limited. This tablet, film coated is formulated for oral use and contains acetaminophen; 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 Marksans Pharma Limited on July 11, 2023. The current certification is valid through December 31, 2026.

How is this Marksans Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 25000008007. 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 (5-3-2)
25000-080-07
11-Digit CMS (5-4-2)
25000-0080-07

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