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  5. NDC Package Code: 79395-011-45 Cold And Flu Severe Night

NDC Package 79395-011-45 Cold And Flu Severe Night

Acetaminophen,Diphenhydramine Hcl,Phenylephrine Hcl Solution 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:
79395-011-45
Package Description:
177 mL in 1 BOTTLE, PLASTIC
Product Code:
79395-011
Proprietary Name:
Cold And Flu Severe Night
Non-Proprietary Name:
Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
Substance Name:
Acetaminophen; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride
Usage Information:
Do not take more than directeddo not take more than 6 doses in any 24-hour periodmL = milliliter; FL OZ = fluid ounceuse only enclosed dosing cup designed for use with this product. Do not use any other dosing device.adults and children 12 years and over: 20 mL in dosing cup provided every 4 hourschildren under 12 years: do not use
11-Digit NDC Billing Format:
79395001145
NDC to RxNorm Crosswalk:
  • RxCUI: 1375932 - acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution
  • RxCUI: 1375932 - acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1375932 - acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution
  • RxCUI: 1375932 - acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution
  • RxCUI: 1375932 - APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Chalkboard Health Inc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 650 mg/20mL
  • DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/20mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL
    • 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 DRUG -
    Start Marketing Date:
    08-26-2020
    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 79395-011-45?

    The NDC Packaged Code 79395-011-45 is assigned to a package of 177 ml in 1 bottle, plastic of Cold And Flu Severe Night, a human over the counter drug labeled by Chalkboard Health Inc. The product's dosage form is solution and is administered via oral form.

    Is NDC 79395-011 included in the NDC Directory?

    Yes, Cold And Flu Severe Night with product code 79395-011 is active and included in the NDC Directory. The product was first marketed by Chalkboard Health Inc on August 26, 2020 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 79395-011-45?

    The 11-digit format is 79395001145. 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
    5-3-279395-011-455-4-279395-0011-45