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  5. NDC Package Code: 50580-434-01 Sudafed Sinus 12 Hour Pressure Plus Pain

NDC Package 50580-434-01 Sudafed Sinus 12 Hour Pressure Plus Pain

Naproxen Sodium And Pseudoephedrine Hydrochloride Tablet, Multilayer, Extended Release - 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:
50580-434-01
Package Description:
2 BLISTER PACK in 1 CARTON / 8 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
50580-434
Proprietary Name:
Sudafed Sinus 12 Hour Pressure Plus Pain
Non-Proprietary Name:
Naproxen Sodium And Pseudoephedrine Hydrochloride
Substance Name:
Naproxen Sodium; Pseudoephedrine Hydrochloride
Usage Information:
Do not take more than directedthe smallest effective dose should be usedswallow whole; do not crush or chewdrink a full glass of water with each doseadults and children 12 years and older1 caplet every 12 hoursdo not take more than 2 caplets in 24 hourschildren under 12 yearsdo not use
11-Digit NDC Billing Format:
50580043401
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
2 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1367426 - naproxen sodium 220 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1367426 - 12 HR naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
  • RxCUI: 1367426 - naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet
Product Type:
Human Otc Drug
Labeler Name:
Kenvue Brands Llc
Dosage Form:
Tablet, Multilayer, Extended Release - A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer portion being the shell, which, additionally, is covered in a designated coating; the tablet is formulated in such manner as to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA076518
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
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.

Frequently Asked Questions

What is NDC 50580-434-01?

The NDC Packaged Code 50580-434-01 is assigned to a package of 2 blister pack in 1 carton / 8 tablet, multilayer, extended release in 1 blister pack of Sudafed Sinus 12 Hour Pressure Plus Pain, a human over the counter drug labeled by Kenvue Brands Llc. The product's dosage form is tablet, multilayer, extended release and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package.

Is NDC 50580-434 included in the NDC Directory?

Yes, Sudafed Sinus 12 Hour Pressure Plus Pain with product code 50580-434 is active and included in the NDC Directory. The product was first marketed by Kenvue Brands Llc 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 NDC billing unit for package 50580-434-01?

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 2.

What is the 11-digit format for NDC 50580-434-01?

The 11-digit format is 50580043401. 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
5-3-250580-434-015-4-250580-0434-01