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  5. NDC Package Code: 63102-104-16 Actinel Dm

NDC Package 63102-104-16 Actinel Dm

Dextromethorphan Hbr,Guaifenesin,Phenylephrine Hcl Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
63102-104-16
Package Description:
474 mL in 1 BOTTLE, PLASTIC
Product Code:
63102-104
Proprietary Name:
Actinel Dm
Non-Proprietary Name:
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Substance Name:
Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
Do not take more than 6 doses in any 24-hour period. Adults and Children 12 years of age and over 5mL (1tsp), every 4 hours Children under 12 years of age ask a doctor
11-Digit NDC Billing Format:
63102010416
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
474 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1091331 - dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution
  • RxCUI: 1091331 - dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution
  • RxCUI: 1091331 - dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Actipharma, Inc
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/5mL
  • GUAIFENESIN 400 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/5mL
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
  • Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    05-20-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 63102-104-16?

    The NDC Packaged Code 63102-104-16 is assigned to a package of 474 ml in 1 bottle, plastic of Actinel Dm, a human over the counter drug labeled by Actipharma, Inc. The product's dosage form is solution and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 474 billable units per package.

    Is NDC 63102-104 included in the NDC Directory?

    Yes, Actinel Dm with product code 63102-104 is active and included in the NDC Directory. The product was first marketed by Actipharma, Inc on May 20, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 63102-104-16?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 474.

    What is the 11-digit format for NDC 63102-104-16?

    The 11-digit format is 63102010416. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-263102-104-165-4-263102-0104-16