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  5. NDC Package Code: 50580-208-08 Motrin Dual Action With Tylenol

NDC Package 50580-208-08 Motrin Dual Action With Tylenol

Acetaminophen And Ibuprofen Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
50580-208-08
Package Description:
1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLE
Product Code:
50580-208
Proprietary Name:
Motrin Dual Action With Tylenol
Non-Proprietary Name:
Acetaminophen And Ibuprofen
Substance Name:
Acetaminophen; Ibuprofen
Usage Information:
■ do not take more than directedadults and children 12 years and over■ take 2 tablets every 8 hours while symptoms persist children under 12 years■ ask a doctor■ do not take more than 6 tablets in 24 hours, unless directed by a doctor
11-Digit NDC Billing Format:
50580020808
NDC to RxNorm Crosswalk:
  • RxCUI: 2387532 - acetaminophen 250 MG / ibuprofen 125 MG Oral Tablet
  • RxCUI: 2387532 - APAP 250 MG / ibuprofen 125 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 250 mg/1
  • IBUPROFEN 125 mg/1
    • Pharmacologic Class(es):
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA214836
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-20-2023
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    50580-208-021 BOTTLE in 1 CARTON / 20 TABLET, FILM COATED in 1 BOTTLE
    50580-208-121 BOTTLE in 1 CARTON / 120 TABLET, FILM COATED in 1 BOTTLE
    50580-208-162 CARTON in 1 CARTON / 1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50580-208-08?

    The NDC Packaged Code 50580-208-08 is assigned to a package of 1 bottle in 1 carton / 80 tablet, film coated in 1 bottle of Motrin Dual Action With Tylenol, 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.

    Is NDC 50580-208 included in the NDC Directory?

    Yes, Motrin Dual Action With Tylenol with product code 50580-208 is active and included in the NDC Directory. The product was first marketed by Johnson & Johnson Consumer Inc. on March 20, 2023 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 50580-208-08?

    The 11-digit format is 50580020808. 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
    5-3-250580-208-085-4-250580-0208-08