Tylenol
NDC Package 50580-412-01
Package Information
Tylenol is 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. Marketed by Kenvue Brands Llc, this product is identified by NDC 50580-412 and is authorized under FDA application M013.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 50580 - Kenvue Brands Llc
- 50580-412 - Tylenol
- 50580-412-01 - 100 TABLET, FILM COATED in 1 BOTTLE
- 50580-412 - Tylenol
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 full disclaimer at the bottom of this page.
Other Available Packages
The following commercial packages are registered under the same Product NDC (50580-412). Click a package code to view its specific billing and regulatory data.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 50580-412-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Tylenol Extra Strength, labeled by Kenvue Brands Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Kenvue Brands Llc on September 19, 2016. The current certification is valid through June 30, 2022.
How is this Kenvue Brands Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 50580041201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
