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  5. NDC Package Code: 50580-536-04 Childrens Sudafed Nasal Decongestant

NDC Package 50580-536-04 Childrens Sudafed Nasal Decongestant

Pseudoephedrine Hydrochloride 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:
50580-536-04
Package Description:
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code:
50580-536
Proprietary Name:
Childrens Sudafed Nasal Decongestant
Non-Proprietary Name:
Pseudoephedrine Hydrochloride
Substance Name:
Pseudoephedrine Hydrochloride
Usage Information:
Find right dose on chart belowmL = milliliterrepeat dose every 4 to 6 hoursdo not use more than 4 times in 24 hoursAge (yr)Dose (mL)under 4 yearsdo not use4 to 5 years5 mL6 to 11 years10 mLAttention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
11-Digit NDC Billing Format:
50580053604
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1049143 - pseudoephedrine HCl 15 MG in 5 mL Oral Solution
  • RxCUI: 1049143 - pseudoephedrine hydrochloride 3 MG/ML Oral Solution
  • RxCUI: 1049143 - pseudoephedrine hydrochloride 15 MG per 5 ML Oral Solution
  • RxCUI: 1049770 - SUDAFED 15 MG in 5 mL Oral Solution
  • RxCUI: 1049770 - pseudoephedrine hydrochloride 3 MG/ML Oral Solution [Sudafed]
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Johnson & Johnson Consumer 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):
  • PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg/5mL
    • Pharmacologic Class(es):
  • Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
  • alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    10-01-2008
    Listing Expiration 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.

    Frequently Asked Questions

    What is NDC 50580-536-04?

    The NDC Packaged Code 50580-536-04 is assigned to a package of 1 bottle in 1 carton / 118 ml in 1 bottle of Childrens Sudafed Nasal Decongestant, a human over the counter drug labeled by Johnson & Johnson Consumer Inc.. The product's dosage form is solution and is administered via oral form.

    Is NDC 50580-536 included in the NDC Directory?

    Yes, Childrens Sudafed Nasal Decongestant with product code 50580-536 is active and included in the NDC Directory. The product was first marketed by Johnson & Johnson Consumer Inc. on October 01, 2008 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 50580-536-04?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 50580-536-04?

    The 11-digit format is 50580053604. 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
    5-3-250580-536-045-4-250580-0536-04