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  5. NDC Package Code: 0067-8205-01 Theraflu Flu Relief Max Strength Nighttime

NDC Package 0067-8205-01 Theraflu Flu Relief Max Strength Nighttime

Acetaminophen,Chlorpheniramine Maleate,Dextromethorphan Hbr Syrup 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:
0067-8205-01
Package Description:
245.5 mL in 1 BOTTLE
Product Code:
0067-8205
Proprietary Name:
Theraflu Flu Relief Max Strength Nighttime
Non-Proprietary Name:
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr
Substance Name:
Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide
Usage Information:
•do not use more than directed•measure the dose correctly using the enclosed dosing cup•adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist•do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor •children under 12 years of age: do not use
11-Digit NDC Billing Format:
00067820501
NDC to RxNorm Crosswalk:
  • RxCUI: 2604562 - acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution
  • RxCUI: 2604562 - acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution
  • RxCUI: 2604562 - acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG per 30 mL Oral Solution
  • RxCUI: 2604562 - APAP 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Haleon Us Holdings Llc
    Dosage Form:
    Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 1000 mg/30mL
  • CHLORPHENIRAMINE MALEATE 4 mg/30mL
  • DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • 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)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    06-27-2022
    Listing Expiration Date:
    12-31-2025
    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 0067-8205-01?

    The NDC Packaged Code 0067-8205-01 is assigned to a package of 245.5 ml in 1 bottle of Theraflu Flu Relief Max Strength Nighttime, a human over the counter drug labeled by Haleon Us Holdings Llc. The product's dosage form is syrup and is administered via oral form.

    Is NDC 0067-8205 included in the NDC Directory?

    Yes, Theraflu Flu Relief Max Strength Nighttime with product code 0067-8205 is active and included in the NDC Directory. The product was first marketed by Haleon Us Holdings Llc on June 27, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0067-8205-01?

    The 11-digit format is 00067820501. 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 4-4-2 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
    4-4-20067-8205-015-4-200067-8205-01