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  5. NDC Package Code: 50580-240-01 Sudafed Sinus Congestion 24 Hour

NDC Package 50580-240-01 Sudafed Sinus Congestion 24 Hour

Pseudoephedrine Hydrochloride Tablet, Film Coated, Extended Release 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:
50580-240-01
Package Description:
1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
50580-240
Proprietary Name:
Sudafed Sinus Congestion 24 Hour
Non-Proprietary Name:
Pseudoephedrine Hydrochloride
Substance Name:
Pseudoephedrine Hydrochloride
Usage Information:
Adults and children 12 years and overswallow one whole tablet with water every 24 hoursdo not exceed one tablet in 24 hoursdo not divide, crush, chew or dissolve the tabletthe tablet does not completely dissolve and may be seen in the stool (this is normal)children under 12 yearsdo not use this product in children under 12 years of age
11-Digit NDC Billing Format:
50580024001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1049670 - pseudoephedrine HCl 240 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1049670 - 24 HR pseudoephedrine hydrochloride 240 MG Extended Release Oral Tablet
  • RxCUI: 1049670 - pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1049672 - SUDAFED 240 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1049672 - 24 HR pseudoephedrine hydrochloride 240 MG Extended Release Oral Tablet [Sudafed]
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Johnson & Johnson Consumer Inc.
    Dosage Form:
    Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • PSEUDOEPHEDRINE HYDROCHLORIDE 240 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
  • alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA020021
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-17-2019
    End Marketing Date:
    09-30-2025
    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 50580-240-01?

    The NDC Packaged Code 50580-240-01 is assigned to a package of 1 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack of Sudafed Sinus Congestion 24 Hour, a human over the counter drug labeled by Johnson & Johnson Consumer Inc.. The product's dosage form is tablet, film coated, extended release and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 50580-240 included in the NDC Directory?

    Yes, Sudafed Sinus Congestion 24 Hour with product code 50580-240 is active and included in the NDC Directory. The product was first marketed by Johnson & Johnson Consumer Inc. on June 17, 2019.

    What is the NDC billing unit for package 50580-240-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 50580-240-01?

    The 11-digit format is 50580024001. 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
    5-3-250580-240-015-4-250580-0240-01