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  5. NDC Package Code: 49580-0297-4 Childrens Plus Cough And Runny Nose

NDC Package 49580-0297-4 Childrens Plus Cough And Runny Nose

Acetaminophen,Chlorpheniramine Maleate,Dextromethorphan Hydrobromide Suspension 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:
49580-0297-4
Package Description:
1 BOTTLE, PLASTIC in 1 BOX / 118 mL in 1 BOTTLE, PLASTIC
Product Code:
49580-0297
Proprietary Name:
Childrens Plus Cough And Runny Nose
Non-Proprietary Name:
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide
Substance Name:
Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide
Usage Information:
This product does not contain directions or complete warnings for adult use.mL = millilitershake well before usingdo not give more than 5 doses in any 24-hour periodmeasure only with dosing cup provided. Do not use any other dosing device.keep dosing cup with productif needed, repeat dose every 4 hours while symptoms lastfind the right dose on chart below. If possible, use weight to dose; otherwise, use ageWeight (lb)Age (yr)Dose (mL) 48-95 6-11 10 mL 36-47 4-5 do not use unless directed by a doctor under 36 under 4do not use
11-Digit NDC Billing Format:
49580029704
NDC to RxNorm Crosswalk:
  • RxCUI: 1086750 - acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG in 5 mL Oral Suspension
  • RxCUI: 1086750 - acetaminophen 32 MG/ML / chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension
  • RxCUI: 1086750 - acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral Suspension
  • RxCUI: 1086750 - APAP 32 MG/ML / Chlorpheniramine Maleate 0.2 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Suspension
    • Product Type:
    Human Otc Drug
    Labeler Name:
    P & L Development, Llc
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 160 mg/5mL
  • CHLORPHENIRAMINE MALEATE 1 mg/5mL
  • DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • 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:
    06-30-2015
    End Marketing Date:
    06-30-2025
    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.

    Frequently Asked Questions

    What is NDC 49580-0297-4?

    The NDC Packaged Code 49580-0297-4 is assigned to a package of 1 bottle, plastic in 1 box / 118 ml in 1 bottle, plastic of Childrens Plus Cough And Runny Nose, a human over the counter drug labeled by P & L Development, Llc. The product's dosage form is suspension and is administered via oral form.

    Is NDC 49580-0297 included in the NDC Directory?

    Yes, Childrens Plus Cough And Runny Nose with product code 49580-0297 is active and included in the NDC Directory. The product was first marketed by P & L Development, Llc on June 30, 2015.

    What is the 11-digit format for NDC 49580-0297-4?

    The 11-digit format is 49580029704. 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
    5-4-149580-0297-45-4-249580-0297-04