Actinel Solution
NDC Package 63102-101-16

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

Package Information

Actinel (dextromethorphan hbr, guaifenesin, pseudoephedrine hcl) solution is • Adults and children 12 years of age and over: Take 1 to 2 teaspoonfuls every 6 hours if needed, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor.• Children 6-12 years, Take ½ to 1 teaspoonful every 6 hours if needed, do not exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor.• Children under 6 years of age: consult a doctor. This formulation utilizes a solution delivery system. Marketed by Actipharma, Llc, this product is identified by NDC 63102-101 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
63102-101-16
Package Description
474 mL in 1 BOTTLE
Product Code
63102-101
11-Digit Billing Format
63102010116
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
474 ML
RxNorm Crosswalk
  • RxCUI: 1098227 - dextromethorphan HBr 15 MG / guaiFENesin 200 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution
  • RxCUI: 1098227 - dextromethorphan hydrobromide 3 MG/ML / guaifenesin 40 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution
  • RxCUI: 1098227 - dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Actinel
Non-Proprietary Name
Dextromethorphan Hbr, Guaifenesin, Pseudoephedrine Hcl
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin; Pseudoephedrine 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
• Adults and children 12 years of age and over: Take 1 to 2 teaspoonfuls every 6 hours if needed, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor.• Children 6-12 years, Take ½ to 1 teaspoonful every 6 hours if needed, do not exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor.• Children under 6 years of age: consult a doctor

Regulatory & Marketing

Labeler Name
Actipharma, Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-24-2014
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 63102-101-16 identifies a specific commercial package of 474 ml in 1 bottle of Actinel, a human over the counter drug labeled by Actipharma, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 474 billable units per package. This solution is formulated for oral use and contains dextromethorphan hydrobromide; guaifenesin; pseudoephedrine 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 Actipharma, Llc on September 24, 2014. The current certification is valid through December 31, 2026.

How is this Actipharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63102010116. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 474 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)
63102-101-16
11-Digit CMS (5-4-2)
63102-0101-16

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