Gencontuss Solution
NDC Package 52083-650-16

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

Package Information

Gencontuss (chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride) solution is a medication used as AntihistamineCough SuppressantNasal Decongestant. This formulation utilizes a solution delivery system. Marketed by Kramer Novis, this product is identified by NDC 52083-650 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
52083-650-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
52083-650
11-Digit Billing Format
52083065016
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk
  • RxCUI: 1363752 - chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral Solution
  • RxCUI: 1363752 - chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution
  • RxCUI: 1363752 - chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Gencontuss
Non-Proprietary Name
Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Substance Name
Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This product is used as AntihistamineCough SuppressantNasal Decongestant. • For temporary relief of runny nose, sneezing, itching of the nose or throat and itchy, watery eyes due to hay fever.• Temporarily relieves cough due to minor throat or bronchial irritation occurring with the common cold.• Temporarily restores freer breathing through the nose.

Regulatory & Marketing

Labeler Name
Kramer Novis
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-08-2015
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 52083-650-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Gencontuss, a human over the counter drug labeled by Kramer Novis. This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package. This solution is formulated for oral use and contains chlorpheniramine maleate; dextromethorphan hydrobromide; phenylephrine hydrochloride 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 Kramer Novis on June 08, 2015. The current certification is valid through December 31, 2026.

How is this Kramer Novis product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52083065016. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
52083-650-16
11-Digit CMS (5-4-2)
52083-0650-16

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