Assured Headache Pm (aspirin Free)
NDC Package 68210-4135-2

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

Package Information

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

Assured Headache Pm (aspirin Free) is do not use more than directeddo not use in children under 12 years of ageadults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor. Marketed by Spirit Pharmaceutical Llc, this product is identified by NDC 68210-4135 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
68210-4135-2
Package Description
1 BOTTLE in 1 CARTON / 20 TABLET, COATED in 1 BOTTLE
Product Code
68210-4135
11-Digit Billing Format
68210413502
RxNorm Crosswalk
  • RxCUI: 1099872 - acetaminophen 500 MG / diphenhydrAMINE citrate 38 MG Oral Tablet
  • RxCUI: 1099872 - acetaminophen 500 MG / diphenhydramine citrate 38 MG Oral Tablet
  • RxCUI: 1099872 - APAP 500 MG / Diphenhydramine Citrate 38 MG Oral Tablet

Clinical Specifications

Proprietary Name
Assured Headache Pm (aspirin Free)
Dosage Form
-
Usage Information
Do not use more than directeddo not use in children under 12 years of ageadults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor

Regulatory & Marketing

Labeler Name
Spirit Pharmaceutical Llc
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-28-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68210-4135-2 identifies a specific commercial package of 1 bottle in 1 carton / 20 tablet, coated in 1 bottle of Assured Headache Pm (aspirin Free), labeled by Spirit Pharmaceutical 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 Pharmaceutical Llc on April 28, 2021. The current certification is valid through December 31, 2025.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68210413502. 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)
68210-4135-2
11-Digit CMS (5-4-2)
68210-4135-02

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