Acetaminophen With Codeine
NDC Package 54348-015-01

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

Package Information

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

Acetaminophen With Codeine is codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. Marketed by Pharmpak, Inc., this product is identified by NDC 54348-015 and is authorized under FDA application ANDA089805.

Identification & Billing

NDC Package Code
54348-015-01
Package Description
1 BLISTER PACK in 1 BOX / 1 TABLET in 1 BLISTER PACK
Product Code
54348-015
11-Digit Billing Format
54348001501
RxNorm Crosswalk
  • RxCUI: 993781 - codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet
  • RxCUI: 993781 - acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet
  • RxCUI: 993781 - APAP 300 MG / codeine phosphate 30 MG Oral Tablet

Clinical Specifications

Proprietary Name
Acetaminophen With Codeine
Dosage Form
-
Usage Information
Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy.This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.

Regulatory & Marketing

Labeler Name
Pharmpak, Inc.
FDA Application #
ANDA089805
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-31-2013
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54348-015-01 identifies a specific commercial package of 1 blister pack in 1 box / 1 tablet in 1 blister pack of Acetaminophen With Codeine, labeled by Pharmpak, Inc.. 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 Pharmpak, Inc. on December 31, 2013. The current certification is valid through December 31, 2017.

How is this Pharmpak, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54348001501. 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)
54348-015-01
11-Digit CMS (5-4-2)
54348-0015-01

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