Acetaminophen And Ibuprofen
NDC Package 51316-401-81

11-digit billing NDC: 51316040181
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing certification is expired.

Acetaminophen And Ibuprofen is ■ do not take more than directed adults and children 12 years and over ■ take 2 caplets every 8 hours while symptoms persist children under 12 years ■ ask a doctor ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor. Marketed by Cvs, this product is identified by NDC 51316-401 and is authorized under FDA application ANDA216592.

Identification & Billing

NDC Package Code
51316-401-81
Package Description
18 TABLET in 1 BOTTLE
Product Code
51316-401
11-Digit Billing Format
51316040181

Clinical Specifications

Proprietary Name
Acetaminophen And Ibuprofen
Dosage Form
-
Usage Information
■ do not take more than directed adults and children 12 years and over ■ take 2 caplets every 8 hours while symptoms persist children 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
Cvs
FDA Application #
ANDA216592
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2025
Listing Expiration
12-31-2027
Exclude Flag
E
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 (51316-401). Click a package code to view its specific billing and regulatory data.

51316-401-72
72 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 51316-401-81 identifies a specific commercial package of 18 tablet in 1 bottle of Acetaminophen And Ibuprofen, labeled by Cvs. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Cvs on July 01, 2025. The current certification is valid through December 31, 2027.

How is this Cvs product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51316040181. 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)
51316-401-81
11-Digit CMS (5-4-2)
51316-0401-81

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