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  5. NDC Package Code: 68210-4135-2 Assured Headache Pm (aspirin Free)

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

Acetaminophen And Diphenhydramine Citrate Tablet, Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
68210-4135-2
Package Description:
1 BOTTLE in 1 CARTON / 20 TABLET, COATED in 1 BOTTLE
Product Code:
68210-4135
Proprietary Name:
Assured Headache Pm (aspirin Free)
Non-Proprietary Name:
Acetaminophen And Diphenhydramine Citrate
Substance Name:
Acetaminophen; Diphenhydramine Citrate
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
11-Digit NDC Billing Format:
68210413502
NDC to 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
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Spirit Pharmaceutical Llc
    Dosage Form:
    Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 500 mg/1
  • DIPHENHYDRAMINE CITRATE 38 mg/1
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M013
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    04-28-2021
    Listing Expiration Date:
    12-31-2024
    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.

    Frequently Asked Questions

    What is NDC 68210-4135-2?

    The NDC Packaged Code 68210-4135-2 is assigned to a package of 1 bottle in 1 carton / 20 tablet, coated in 1 bottle of Assured Headache Pm (aspirin Free), a human over the counter drug labeled by Spirit Pharmaceutical Llc. The product's dosage form is tablet, coated and is administered via oral form.

    Is NDC 68210-4135 included in the NDC Directory?

    Yes, Assured Headache Pm (aspirin Free) with product code 68210-4135 is active and included in the NDC Directory. The product was first marketed by Spirit Pharmaceutical Llc on April 28, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 68210-4135-2?

    The 11-digit format is 68210413502. 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 5-4-1 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
    5-4-168210-4135-25-4-268210-4135-02