Apinophen
NDC Package 46084-061-22

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Apinophen is do not take more than directed (see overdose warning)adults and children 12 years and over: take 2 caplets every 6 hours while symptoms lastswallow whole – do not crush, chew, or dissolvedo not take more than 6 caplets in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctorchildren under 12 years : ask a doctor. Marketed by A P J Laboratories Limited, this product is identified by NDC 46084-061 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
46084-061-22
Package Description
60 TABLET in 1 BLISTER PACK
Product Code
46084-061
11-Digit Billing Format
46084006122
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Apinophen Extra Strength
Dosage Form
-
Usage Information
Do not take more than directed (see overdose warning)adults and children 12 years and over: take 2 caplets every 6 hours while symptoms lastswallow whole – do not crush, chew, or dissolvedo not take more than 6 caplets in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctorchildren under 12 years : ask a doctor

Regulatory & Marketing

Labeler Name
A P J Laboratories Limited
FDA Application #
part343
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
03-01-2013
Listing Expiration
12-31-2017
Exclude Flag
I
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 (46084-061). Click a package code to view its specific billing and regulatory data.

46084-061-11
2 TABLET in 1 BLISTER PACK
46084-061-23
120 TABLET in 1 BLISTER PACK
46084-061-24
250 TABLET in 1 BLISTER PACK
46084-061-25
500 TABLET in 1 BLISTER PACK
46084-061-26
100 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 46084-061-22 identifies a specific commercial package of 60 tablet in 1 blister pack of Apinophen Extra Strength, labeled by A P J Laboratories Limited. 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 A P J Laboratories Limited on March 01, 2013. The current certification is valid through December 31, 2017.

How is this A P J Laboratories Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46084006122. 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)
46084-061-22
11-Digit CMS (5-4-2)
46084-0061-22

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