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  5. NDC Package Code: 50580-344-01 Extra Strength Tylenol Cold Plus Flu Multi-action Day

NDC Package 50580-344-01 Extra Strength Tylenol Cold Plus Flu Multi-action Day

Acetaminophen,Pseudoephedrine Hydrochloride,And Dextromethorphan Hydrobromide Tablet, Film - 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:
50580-344-01
Package Description:
2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
50580-344
Proprietary Name:
Extra Strength Tylenol Cold Plus Flu Multi-action Day
Non-Proprietary Name:
Acetaminophen, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Pseudoephedrine Hydrochloride
Usage Information:
Do not take more than directed (see overdose warning)adults and children 12 years and overtake 2 caplets every 6 hours while symptoms lastdo not take more than 6 caplets in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctorchildren under 12 yearsask a doctor
11-Digit NDC Billing Format:
50580034401
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
2 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1250743 - acetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet
  • RxCUI: 1250743 - acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet
  • RxCUI: 1250743 - APAP 500 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Johnson & Johnson Consumer Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 500 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
  • PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha-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-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    06-21-2021
    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 50580-344-01?

    The NDC Packaged Code 50580-344-01 is assigned to a package of 2 blister pack in 1 carton / 12 tablet, film coated in 1 blister pack of Extra Strength Tylenol Cold Plus Flu Multi-action Day, a human over the counter drug labeled by Johnson & Johnson Consumer Inc.. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package.

    Is NDC 50580-344 included in the NDC Directory?

    Yes, Extra Strength Tylenol Cold Plus Flu Multi-action Day with product code 50580-344 is active and included in the NDC Directory. The product was first marketed by Johnson & Johnson Consumer Inc. on June 21, 2021 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 NDC billing unit for package 50580-344-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 2.

    What is the 11-digit format for NDC 50580-344-01?

    The 11-digit format is 50580034401. 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
    5-3-250580-344-015-4-250580-0344-01