NDC Package 50580-437-03 Sudafed Pe Sinus Congestion

Phenylephrine Hydrochloride Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

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:
50580-437-03
Package Description:
3 CARTON in 1 PACKAGE / 2 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
Proprietary Name:
Sudafed Pe Sinus Congestion
Non-Proprietary Name:
Phenylephrine Hydrochloride
Substance Name:
Phenylephrine Hydrochloride
Usage Information:
Adults and children 12 years and overtake 1 tablet every 4 hoursdo not take more than 6 tablets in 24 hourschildren under 12 yearsask a doctor
11-Digit NDC Billing Format:
50580043703
NDC to RxNorm Crosswalk:
  • RxCUI: 1049182 - phenylephrine HCl 10 MG Oral Tablet
  • RxCUI: 1049182 - phenylephrine hydrochloride 10 MG Oral Tablet
  • RxCUI: 1052767 - SUDAFED PE 10 MG Oral Tablet
  • RxCUI: 1052767 - phenylephrine hydrochloride 10 MG Oral Tablet [Sudafed PE]
  • RxCUI: 1052767 - Sudafed PE 10 MG Oral Tablet
  • Product Type:
    Human Otc Drug
    Labeler Name:
    Johnson & Johnson Consumer Inc.
    Dosage Form:
    Tablet, Film Coated - 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.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    06-17-2019
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    50580-437-011 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK
    50580-437-022 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50580-437-03?

    The NDC Packaged Code 50580-437-03 is assigned to a package of 3 carton in 1 package / 2 blister pack in 1 carton / 18 tablet, film coated in 1 blister pack of Sudafed Pe Sinus Congestion, a human over the counter drug labeled by Johnson & Johnson Consumer Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 50580-437 included in the NDC Directory?

    Yes, Sudafed Pe Sinus Congestion with product code 50580-437 is active and included in the NDC Directory. The product was first marketed by Johnson & Johnson Consumer Inc. on June 17, 2019 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 11-digit format for NDC 50580-437-03?

    The 11-digit format is 50580043703. 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
    5-3-250580-437-035-4-250580-0437-03