Acetaminophen And Ibuprofen Tablet, Film Coated
NDC Package 53943-034-76

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

Package Information

Acetaminophen And Ibuprofen tablets is usestemporarily relieves minor aches and pains due to:headachetoothachebackachemenstrual crampsmuscular achesminor pain of arthritis. This formulation utilizes a tablet, film coated delivery system. Marketed by Discount Drug Mart, Inc., this product is identified by NDC 53943-034 and is authorized under FDA application ANDA216999.

Identification & Billing

NDC Package Code
53943-034-76
Package Description
72 TABLET, FILM COATED in 1 CARTON
Product Code
53943-034
11-Digit Billing Format
53943003476
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acetaminophen And Ibuprofen
Non-Proprietary Name
Acetaminophen And Ibuprofen
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
Usestemporarily relieves minor aches and pains due to:headachetoothachebackachemenstrual crampsmuscular achesminor pain of arthritis

Regulatory & Marketing

Labeler Name
Discount Drug Mart, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA216999
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-08-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53943-034-76 identifies a specific commercial package of 72 tablet, film coated in 1 carton of Acetaminophen And Ibuprofen, a human over the counter drug labeled by Discount Drug Mart, Inc.. 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 Discount Drug Mart, Inc. on September 08, 2023. The current certification is valid through December 31, 2026.

How is this Discount Drug Mart, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53943003476. 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)
53943-034-76
11-Digit CMS (5-4-2)
53943-0034-76

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