Tylenol Extra Strength Tablet, Film Coated
NDC Package 53209-1001-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tylenol Extra Strength (acetaminophen) tablets is a medication used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever. This formulation utilizes a tablet, film coated delivery system. Marketed by Morning Star Otc, this product is identified by NDC 53209-1001 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
53209-1001-2
Package Description
25 BLISTER PACK in 1 POUCH / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1001-1)
Product Code
53209-1001
11-Digit Billing Format
53209100102
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tylenol Extra Strength
Non-Proprietary Name
Acetaminophen
Substance Name
Acetaminophen
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ACETAMINOPHEN 500 mg/1
Usage Information
This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Regulatory & Marketing

Labeler Name
Morning Star Otc
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-19-1984
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53209-1001-2 identifies a specific commercial package of 25 blister pack in 1 pouch / 2 tablet, film coated in 1 blister pack (53209-1001-1) of Tylenol Extra Strength, a human over the counter drug labeled by Morning Star Otc. This tablet, film coated is formulated for oral use and contains acetaminophen as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Morning Star Otc on August 19, 1984. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

How is this Morning Star Otc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53209100102. 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:

10-Digit Format (5-4-1)
53209-1001-2
11-Digit CMS (5-4-2)
53209-1001-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.