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  5. NDC Package Code: 53943-204-10 Pseudoephedrine Hydrochloride

NDC Package 53943-204-10 Pseudoephedrine Hydrochloride

Tablet, 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:
53943-204-10
Package Description:
1 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
53943-204
Proprietary Name:
Pseudoephedrine Hydrochloride
Non-Proprietary Name:
Pseudoephedrine Hydrochloride
Substance Name:
Pseudoephedrine Hydrochloride
Usage Information:
Adults and children 12 years and overtake 1 tablet every 12 hoursdo not take more than 2 tablets in 24 hourschildren under 12 yearsdo not use this product in children under 12 years of age
11-Digit NDC Billing Format:
53943020410
NDC to RxNorm Crosswalk:
  • RxCUI: 1049154 - pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1049154 - 12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
  • RxCUI: 1049154 - pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Discount Drug Mart
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • PSEUDOEPHEDRINE HYDROCHLORIDE 120 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:
    ANDA077442
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-02-2018
    Listing Expiration Date:
    12-31-2024
    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 53943-204-10?

    The NDC Packaged Code 53943-204-10 is assigned to a package of 1 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack of Pseudoephedrine Hydrochloride, a human over the counter drug labeled by Discount Drug Mart. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 53943-204 included in the NDC Directory?

    Yes, Pseudoephedrine Hydrochloride with product code 53943-204 is active and included in the NDC Directory. The product was first marketed by Discount Drug Mart on March 02, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53943-204-10?

    The 11-digit format is 53943020410. 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
    5-3-253943-204-105-4-253943-0204-10