Extra Strength Acetaminophen
NDC Package 68210-4097-2

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Extra Strength Acetaminophen is do not take more than directed (see overdose warning) adults and children 12 years and over take 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 doctor children under 12 years ask a doctor. Marketed by Spirit Pharmaceuticals Llc, this product is identified by NDC 68210-4097 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
68210-4097-2
Package Description
1 BOTTLE in 1 PACKAGE / 25 TABLET in 1 BOTTLE
Product Code
68210-4097
11-Digit Billing Format
68210409702
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Extra Strength Acetaminophen
Dosage Form
-
Usage Information
Do not take more than directed (see overdose warning) adults and children 12 years and over take 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 doctor children under 12 years ask a doctor

Regulatory & Marketing

Labeler Name
Spirit Pharmaceuticals Llc
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-02-2020
Listing Expiration
12-31-2025
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68210-4097). Click a package code to view its specific billing and regulatory data.

68210-4097-1
100 TABLET in 1 BOTTLE

* 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 68210-4097-2 identifies a specific commercial package of 1 bottle in 1 package / 25 tablet in 1 bottle of Extra Strength Acetaminophen, labeled by Spirit Pharmaceuticals Llc. 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 Spirit Pharmaceuticals Llc on July 02, 2020. The current certification is valid through December 31, 2025.

How is this Spirit Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68210409702. 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)
68210-4097-2
11-Digit CMS (5-4-2)
68210-4097-02

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