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  5. NDC Package Code: 76095-010-20 Cold Medicine Xl3 Forte

NDC Package 76095-010-20 Cold Medicine Xl3 Forte

Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
76095-010-20
Package Description:
2 BLISTER PACK in 1 BOX / 10 TABLET in 1 BLISTER PACK (76095-010-02)
Product Code:
76095-010
Proprietary Name:
Cold Medicine Xl3 Forte
Non-Proprietary Name:
Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
Substance Name:
Acetaminophen; Chlorpheniramine Maleate; Phenylephrine Hydrochloride
Usage Information:
■ Do not use more than directed (see overdose warning) ■ Adults and children 12 years of age and older: take 1 tablet every 4 hours Do not take more than 6 tablets in 24 hours ■ Children under 12 years of age: do not use because this product contains to much medication for children under this age.
11-Digit NDC Billing Format:
76095001020
NDC to RxNorm Crosswalk:
  • RxCUI: 1193293 - acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral Tablet
  • RxCUI: 1193293 - acetaminophen 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet
  • RxCUI: 1193293 - APAP 325 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Midway Importing Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 325 mg/1
  • CHLORPHENIRAMINE MALEATE 4 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    08-01-2017
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    76095-010-101 BLISTER PACK in 1 BOX / 10 TABLET in 1 BLISTER PACK (76095-010-01)
    76095-010-5050 PACKET in 1 BOX / 4 TABLET in 1 PACKET (76095-010-04)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 76095-010-20?

    The NDC Packaged Code 76095-010-20 is assigned to a package of 2 blister pack in 1 box / 10 tablet in 1 blister pack (76095-010-02) of Cold Medicine Xl3 Forte, a human over the counter drug labeled by Midway Importing Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 76095-010 included in the NDC Directory?

    Yes, Cold Medicine Xl3 Forte with product code 76095-010 is active and included in the NDC Directory. The product was first marketed by Midway Importing Inc. on August 01, 2017 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 76095-010-20?

    The 11-digit format is 76095001020. 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 5-3-2 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
    5-3-276095-010-205-4-276095-0010-20