Desgen Solution/ Drops
NDC Package 52083-641-01

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

Package Information

Desgen (dextromethorphan hbr, guiafenesin, phenylephrine hcl) solution/ dropses is other information Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.Store at controlled room temperature 15-30°C (59-86°F).Avoid excessive heat and humidity. This formulation utilizes a solution/ drops delivery system. Marketed by Kramer Novis, this product is identified by NDC 52083-641 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
52083-641-01
Package Description
30 mL in 1 BOTTLE, DROPPER
Product Code
52083-641
11-Digit Billing Format
52083064101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
30 ML
RxNorm Crosswalk
  • RxCUI: 1095503 - dextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 1 mL Oral Solution
  • RxCUI: 1095503 - dextromethorphan hydrobromide 5 MG/ML / guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution
  • RxCUI: 1095503 - dextromethorphan HBr 5 MG / guaifenesin 50 MG / phenylephrine HCl 2.5 MG per 1 ML Oral Drops

Clinical Specifications

Proprietary Name
Desgen Pediatric
Non-Proprietary Name
Dextromethorphan Hbr, Guiafenesin, Phenylephrine Hcl
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Other information Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.Store at controlled room temperature 15-30°C (59-86°F).Avoid excessive heat and humidity.

Regulatory & Marketing

Labeler Name
Kramer Novis
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-27-2014
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 52083-641-01 identifies a specific commercial package of 30 ml in 1 bottle, dropper of Desgen Pediatric, a human over the counter drug labeled by Kramer Novis. This product is billed per "ML" milliliter and contains an estimated amount of 30 billable units per package. This solution/ drops is formulated for oral use and contains dextromethorphan hydrobromide; guaifenesin; 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 January 27, 2014. 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: 52083064101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 30 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)
52083-641-01
11-Digit CMS (5-4-2)
52083-0641-01

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