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  5. NDC Package Code: 70000-0004-1 Leader Mucus Relief D

NDC Package 70000-0004-1 Leader Mucus Relief D

Guaifenesin,Pseudoephedrine Hydrochloride Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
70000-0004-1
Package Description:
36 BLISTER PACK in 1 CARTON / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
70000-0004
Proprietary Name:
Leader Mucus Relief D
Non-Proprietary Name:
Guaifenesin, Pseudoephedrine Hydrochloride
Substance Name:
Guaifenesin; Pseudoephedrine Hydrochloride
Usage Information:
•do not crush, chew, or break tablet•take with a full glass of water•this product can be administered without regard for timing of meals•adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours•children under 12 years of age: do not use
11-Digit NDC Billing Format:
70000000401
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
36 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1305603 - guaiFENesin 600 MG / pseudoephedrine HCl 60 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1305603 - 12 HR guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG Extended Release Oral Tablet
  • RxCUI: 1305603 - guaifenesin 600 MG / pseudoephedrine hydrochloride 60 MG 12 HR Extended Release Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Cardinal Health 110, Llc. Dba Leader
    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):
  • GUAIFENESIN 600 mg/1
  • PSEUDOEPHEDRINE HYDROCHLORIDE 60 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:
    ANDA091071
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-16-2020
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    70000-0004-218 BLISTER PACK in 1 CARTON / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70000-0004-1?

    The NDC Packaged Code 70000-0004-1 is assigned to a package of 36 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack of Leader Mucus Relief D, a human over the counter drug labeled by Cardinal Health 110, Llc. Dba Leader. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 70000-0004 included in the NDC Directory?

    Yes, Leader Mucus Relief D with product code 70000-0004 is active and included in the NDC Directory. The product was first marketed by Cardinal Health 110, Llc. Dba Leader on January 16, 2020 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 70000-0004-1?

    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 36.

    What is the 11-digit format for NDC 70000-0004-1?

    The 11-digit format is 70000000401. 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
    5-4-170000-0004-15-4-270000-0004-01