Pharbinex-dm Tablet
NDC Package 16103-381-04

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

Package Information

Pharbinex-dm (guaifenesin 400mg and dextromethorphan hbr 20mg) tablets 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 tablet every 4 hours as neededchildren 6 to under 12 years of agetake ½ tablet every 4 hours as neededchildren under 6 years of ageconsult a doctor. This formulation utilizes a tablet delivery system. Marketed by Pharbest Pharmaceuticals, Inc., this product is identified by NDC 16103-381 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
16103-381-04
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 30 TABLET in 1 BOTTLE, PLASTIC
Product Code
16103-381
11-Digit Billing Format
16103038104
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1147685 - dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral Tablet
  • RxCUI: 1147685 - dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet
  • RxCUI: 1147685 - guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral Tablet

Clinical Specifications

Proprietary Name
Pharbinex-dm
Non-Proprietary Name
Guaifenesin 400mg And Dextromethorphan Hbr 20mg
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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 tablet every 4 hours as neededchildren 6 to under 12 years of agetake ½ tablet every 4 hours as neededchildren under 6 years of ageconsult a doctor

Regulatory & Marketing

Labeler Name
Pharbest Pharmaceuticals, Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-02-2018
Listing Expiration
12-31-2026
Exclude Flag
N
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 16103-381-04 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 30 tablet in 1 bottle, plastic of Pharbinex-dm, a human over the counter drug labeled by Pharbest Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet is formulated for oral use and contains dextromethorphan hydrobromide; guaifenesin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Pharbest Pharmaceuticals, Inc. on April 02, 2018. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16103038104. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
16103-381-04
11-Digit CMS (5-4-2)
16103-0381-04

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