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  5. NDC Package Code: 49580-0342-2 Night Time Cold And Flu

NDC Package 49580-0342-2 Night Time Cold And Flu

Acetaminophen,Dextromethorphan Hydrobromide,Doxylamine Succinate Liquid 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:
49580-0342-2
Package Description:
355 mL in 1 BOTTLE, PLASTIC
Product Code:
49580-0342
Proprietary Name:
Night Time Cold And Flu
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate
Usage Information:
Take only as recommended (see overdose warning)do not exceed 4 doses per 24 hours use dosing cup provided mL= milliliter agedoseadults & children 12 yrs and over30 mL every 6 hourschildren 4 to 11 yrsdo not use unless directed by a doctorchildren under 4 yrsdo not useWhen using Day Time or Night Time products, carefully read each label to ensure correct dosing.
11-Digit NDC Billing Format:
49580034202
NDC to RxNorm Crosswalk:
  • RxCUI: 1042684 - acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution
  • RxCUI: 1042684 - acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
  • RxCUI: 1042684 - acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
  • RxCUI: 1042684 - acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
  • RxCUI: 1042684 - APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    P & L Development, Llc
    Dosage Form:
    Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 500 mg/15mL
  • DEXTROMETHORPHAN HYDROBROMIDE 15 mg/15mL
  • DOXYLAMINE SUCCINATE 6.25 mg/15mL
    • Pharmacologic Class(es):
  • Antihistamine - [EPC] (Established Pharmacologic Class)
  • Histamine Receptor Antagonists - [MoA] (Mechanism of Action)
  • Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
  • Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    02-28-2015
    End Marketing Date:
    12-31-2025
    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
    49580-0342-1296 mL in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 49580-0342-2?

    The NDC Packaged Code 49580-0342-2 is assigned to a package of 355 ml in 1 bottle, plastic of Night Time Cold And Flu, a human over the counter drug labeled by P & L Development, Llc. The product's dosage form is liquid and is administered via oral form.

    Is NDC 49580-0342 included in the NDC Directory?

    Yes, Night Time Cold And Flu with product code 49580-0342 is active and included in the NDC Directory. The product was first marketed by P & L Development, Llc on February 28, 2015.

    What is the 11-digit format for NDC 49580-0342-2?

    The 11-digit format is 49580034202. 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
    5-4-149580-0342-25-4-249580-0342-02