NDC Package 50580-208-12 Motrin Dual Action With Tylenol

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

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:
50580-208-12
Package Description:
1 BOTTLE in 1 CARTON / 120 TABLET, FILM COATED in 1 BOTTLE
Product Code:
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:
50580020812
NDC to RxNorm Crosswalk:
Product Type:
Human Otc Drug
Labeler Name:
Kenvue Brands Llc
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.
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:
12-31-2026
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
50580-208-081 BOTTLE in 1 CARTON / 80 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 50580-208-12?

The NDC Packaged Code 50580-208-12 is assigned to a package of 1 bottle in 1 carton / 120 tablet, film coated in 1 bottle of Motrin Dual Action With Tylenol, a human over the counter drug labeled by Kenvue Brands Llc. 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 Kenvue Brands Llc on March 20, 2023 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 50580-208-12?

The 11-digit format is 50580020812. 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
5-3-250580-208-125-4-250580-0208-12