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  5. NDC Package Code: 43063-801-90 Guaifenesin Dm

NDC Package 43063-801-90 Guaifenesin Dm

Guaifenesin And Dextromethorphan Hydrobromide Tablet 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:
43063-801-90
Package Description:
90 TABLET in 1 BOTTLE, PLASTIC
Product Code:
43063-801
Proprietary Name:
Guaifenesin Dm
Non-Proprietary Name:
Guaifenesin And Dextromethorphan Hydrobromide
Substance Name:
Dextromethorphan Hydrobromide; Guaifenesin
Usage Information:
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common coldHelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucusHelps make coughs more productive.These highlights do not include all the information needed to use Guaifenesin DM, See full prescribing information for Guaifenesin DM Initial U.S. Approval 04/29/2004
11-Digit NDC Billing Format:
43063080190
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
90 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1147685 - dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral Tablet
  • RxCUI: 1147685 - dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet
  • RxCUI: 1147685 - guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Pd-rx Pharmaceuticals, Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1
  • GUAIFENESIN 400 mg/1
    • Pharmacologic Class(es):
  • Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
  • Expectorant - [EPC] (Established Pharmacologic Class)
  • Increased Respiratory Secretions - [PE] (Physiologic Effect)
  • Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
  • Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    04-02-2018
    End Marketing Date:
    11-30-2027
    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
    43063-801-3030 TABLET in 1 BOTTLE, PLASTIC
    43063-801-6060 TABLET in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43063-801-90?

    The NDC Packaged Code 43063-801-90 is assigned to a package of 90 tablet in 1 bottle, plastic of Guaifenesin Dm, a human over the counter drug labeled by Pd-rx Pharmaceuticals, Inc.. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package.

    Is NDC 43063-801 included in the NDC Directory?

    Yes, Guaifenesin Dm with product code 43063-801 is active and included in the NDC Directory. The product was first marketed by Pd-rx Pharmaceuticals, Inc. on April 02, 2018.

    What is the NDC billing unit for package 43063-801-90?

    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 90.

    What is the 11-digit format for NDC 43063-801-90?

    The 11-digit format is 43063080190. 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
    5-3-243063-801-905-4-243063-0801-90