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  5. NDC Package Code: 49580-0499-4 Night Time Cough

NDC Package 49580-0499-4 Night Time Cough

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:
49580-0499-4
Package Description:
118 mL in 1 BOTTLE, PLASTIC
Product Code:
49580-0499
Proprietary Name:
Night Time Cough
Non-Proprietary Name:
Dextromethorphan Hydrobromide, Doxylamine Succinate
Substance Name:
Dextromethorphan Hydrobromide; Doxylamine Succinate
Usage Information:
Do not take more than 4 doses in any 24-hour periodtake only as directedmeasure only with dosing cup provided. Do not use any other dosing devicemL = milliliteradults and children 12 years and over: 30 mL every 6 hourschildren under 12 years of age: do not use
11-Digit NDC Billing Format:
49580049904
NDC to RxNorm Crosswalk:
  • RxCUI: 1234386 - dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution
  • RxCUI: 1234386 - dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
  • RxCUI: 1234386 - dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
  • RxCUI: 1234386 - dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 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):
  • DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL
  • DOXYLAMINE SUCCINATE 12.5 mg/30mL
    • 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:
    12-31-2017
    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
    49580-0499-2355 mL in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 49580-0499-4?

    The NDC Packaged Code 49580-0499-4 is assigned to a package of 118 ml in 1 bottle, plastic of Night Time Cough, 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 49580-0499 included in the NDC Directory?

    Yes, Night Time Cough with product code 49580-0499 is active and included in the NDC Directory. The product was first marketed by P & L Development, Llc on December 31, 2017.

    What is the 11-digit format for NDC 49580-0499-4?

    The 11-digit format is 49580049904. 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
    5-4-149580-0499-45-4-249580-0499-04