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  5. NDC Package Code: 36800-989-50 Topcare Chest Congestion And Sinus Congestion Relief Pe

NDC Package 36800-989-50 Topcare Chest Congestion And Sinus Congestion Relief Pe

Guaifenesin/phenylephrine Tablet 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:
36800-989-50
Package Description:
1 BOTTLE in 1 CARTON / 50 TABLET in 1 BOTTLE
Product Code:
36800-989
Proprietary Name:
Topcare Chest Congestion And Sinus Congestion Relief Pe
Non-Proprietary Name:
Guaifenesin/phenylephrine
Substance Name:
Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
■ adults and children 12 years and over:take 1 caplet every 4 hours as needed■ children 6 to under 12 years:take 1/2 caplet every 4 hours as needed■ children under 6 years: consult a doctorDo not exceed 6 doses in a 24 hour period or as directed by a doctor.
11-Digit NDC Billing Format:
36800098950
NDC to RxNorm Crosswalk:
  • RxCUI: 1304111 - guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral Tablet
  • RxCUI: 1304111 - guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Topco Associates Llc
    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):
  • GUAIFENESIN 400 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
  • Expectorant - [EPC] (Established Pharmacologic Class)
  • Increased Respiratory Secretions - [PE] (Physiologic Effect)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    06-05-2006
    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 36800-989-50?

    The NDC Packaged Code 36800-989-50 is assigned to a package of 1 bottle in 1 carton / 50 tablet in 1 bottle of Topcare Chest Congestion And Sinus Congestion Relief Pe, a human over the counter drug labeled by Topco Associates Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 36800-989 included in the NDC Directory?

    Yes, Topcare Chest Congestion And Sinus Congestion Relief Pe with product code 36800-989 is active and included in the NDC Directory. The product was first marketed by Topco Associates Llc on June 05, 2006 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 36800-989-50?

    The 11-digit format is 36800098950. 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
    5-3-236800-989-505-4-236800-0989-50