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  5. NDC Package Code: 70000-0475-1 Leader 12 Hour Nasal Decongestant

NDC Package 70000-0475-1 Leader 12 Hour Nasal Decongestant

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:
70000-0475-1
Package Description:
10 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
70000-0475
Proprietary Name:
Leader 12 Hour Nasal Decongestant
Non-Proprietary Name:
Pseudoephedrine Hydrochloride
Substance Name:
Pseudoephedrine Hydrochloride
Usage Information:
Adults and children 12 years and over •take 1 tablet every 12 hours•do 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:
70000047501
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
10 EA
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:
    Cardinal Health 110, Llc. Dba Leader
    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 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:
    ANDA075153
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-11-2019
    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 70000-0475-1?

    The NDC Packaged Code 70000-0475-1 is assigned to a package of 10 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack of Leader 12 Hour Nasal Decongestant, a human over the counter drug labeled by Cardinal Health 110, Llc. Dba Leader. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 70000-0475 included in the NDC Directory?

    Yes, Leader 12 Hour Nasal Decongestant with product code 70000-0475 is active and included in the NDC Directory. The product was first marketed by Cardinal Health 110, Llc. Dba Leader on February 11, 2019 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 NDC billing unit for package 70000-0475-1?

    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 10.

    What is the 11-digit format for NDC 70000-0475-1?

    The 11-digit format is 70000047501. 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 5-4-1 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
    5-4-170000-0475-15-4-270000-0475-01