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  5. NDC Package Code: 76162-823-12 Cold And Flu Severe Daytime/nighttime

NDC Package 76162-823-12 Cold And Flu Severe Daytime/nighttime

Acetaminophen,Dextromethorphan Hydrobromide,Guaifenesin,Phenylephrine - 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:
76162-823-12
Package Description:
1 KIT in 1 CARTON * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code:
76162-823
Proprietary Name:
Cold And Flu Severe Daytime/nighttime
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, Doxylamine Succinate
Usage Information:
• take only as directed • do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use • take only as directed • do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
11-Digit NDC Billing Format:
76162082312
NDC to RxNorm Crosswalk:
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1297288 - APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule
  • RxCUI: 1656815 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1656815 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Topco Associates Llc
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    11-03-2023
    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 76162-823-12?

    The NDC Packaged Code 76162-823-12 is assigned to a package of 1 kit in 1 carton * 12 capsule, liquid filled in 1 blister pack * 12 capsule, liquid filled in 1 blister pack of Cold And Flu Severe Daytime/nighttime, a human over the counter drug labeled by Topco Associates Llc. The product's dosage form is kit and is administered via form.

    Is NDC 76162-823 included in the NDC Directory?

    Yes, Cold And Flu Severe Daytime/nighttime with product code 76162-823 is active and included in the NDC Directory. The product was first marketed by Topco Associates Llc on November 03, 2023 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 76162-823-12?

    The 11-digit format is 76162082312. 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
    5-3-276162-823-125-4-276162-0823-12