Pharbinex-pe
NDC Package 16103-389-04

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.

Pharbinex-pe is take with a full glass of waterthis product can be administered without regard for the timing of mealsdo not exceed 6 doses in 24 hours or as directed by doctoradults and children 12 years of age and overtake 1 caplet every 4 hours as neededchildren 6 to under 12 years of agetake ½ caplet every 4 hours as neededchildren under 6 years of ageconsult a doctor. Marketed by Pharbest Pharmaceuticals, Inc., this product is identified by NDC 16103-389 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
16103-389-04
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 30 TABLET, COATED in 1 BOTTLE, PLASTIC
Product Code
16103-389
11-Digit Billing Format
16103038904
RxNorm Crosswalk
  • RxCUI: 1304111 - guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral Tablet
  • RxCUI: 1304111 - guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral Tablet

Clinical Specifications

Proprietary Name
Pharbinex-pe
Dosage Form
-
Usage Information
Take with a full glass of waterthis product can be administered without regard for the timing of mealsdo not exceed 6 doses in 24 hours or as directed by doctoradults and children 12 years of age and overtake 1 caplet every 4 hours as neededchildren 6 to under 12 years of agetake ½ caplet every 4 hours as neededchildren under 6 years of ageconsult a doctor

Regulatory & Marketing

Labeler Name
Pharbest Pharmaceuticals, Inc.
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
05-01-2018
Listing Expiration
12-31-2021
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 16103-389-04 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 30 tablet, coated in 1 bottle, plastic of Pharbinex-pe, labeled by Pharbest Pharmaceuticals, 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 Pharbest Pharmaceuticals, Inc. on May 01, 2018. The current certification is valid through December 31, 2021.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16103038904. 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)
16103-389-04
11-Digit CMS (5-4-2)
16103-0389-04

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