Acetaminophen Phenylephrine Hcl
NDC Package 69168-261-99

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 Phenylephrine Hcl is adults and children 12 years of age and older: take 2 tablets every 4-6 hours Do not take more than 8 tablets in 24 hours Do not use in children under 12 years of age. Marketed by Allegiant Health, this product is identified by NDC 69168-261 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
69168-261-99
Package Description
23437 TABLET in 1 CARTON
Product Code
69168-261
11-Digit Billing Format
69168026199
RxNorm Crosswalk
  • RxCUI: 1101534 - acetaminophen 500 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1101534 - acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1101534 - APAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Acetaminophen Phenylephrine Hcl
Dosage Form
-
Usage Information
Adults and children 12 years of age and older: take 2 tablets every 4-6 hours Do not take more than 8 tablets in 24 hours Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) and could cause serious health problems

Regulatory & Marketing

Labeler Name
Allegiant Health
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
12-01-2014
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 69168-261-99 identifies a specific commercial package of 23437 tablet in 1 carton of Acetaminophen Phenylephrine Hcl, labeled by Allegiant Health. 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 Allegiant Health on December 01, 2014. The current certification is valid through December 31, 2017.

How is this Allegiant Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69168026199. 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)
69168-261-99
11-Digit CMS (5-4-2)
69168-0261-99

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