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  5. NDC Package Code: 69367-272-04 Codeine-guaifenesin

NDC Package 69367-272-04 Codeine-guaifenesin

Codeine Phosphate And Guaifenesin Solution 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:
69367-272-04
Package Description:
118 mL in 1 BOTTLE
Product Code:
69367-272
Proprietary Name:
Codeine-guaifenesin
Non-Proprietary Name:
Codeine Phosphate And Guaifenesin
Substance Name:
Codeine Phosphate; Guaifenesin
Usage Information:
Do not exceed 6 doses in 24 hours.Adults and children 12 years of age and over:2 tsp (10 mL) every 4 hours, or as directed by a doctor.Children 6 to under 12 years of age:1 tsp (5 mL) every 4 hours, or as directed by a doctor.Children under 6 years of age:Consult a doctor.
11-Digit NDC Billing Format:
69367027204
NDC to RxNorm Crosswalk:
  • RxCUI: 995868 - codeine phosphate 10 MG / guaiFENesin 100 MG in 5 mL Oral Solution
  • RxCUI: 995868 - codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML Oral Solution
  • RxCUI: 995868 - codeine phosphate 10 MG / guaifenesin 100 MG per 5 ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Westminster Pharmaceuticals, Llc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CODEINE PHOSPHATE 10 mg/5mL
  • GUAIFENESIN 100 mg/5mL
    • Pharmacologic Class(es):
  • Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
  • Expectorant - [EPC] (Established Pharmacologic Class)
  • Full Opioid Agonists - [MoA] (Mechanism of Action)
  • Increased Respiratory Secretions - [PE] (Physiologic Effect)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule V (CV) Substances
    Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    07-15-2020
    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
    69367-272-16473 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69367-272-04?

    The NDC Packaged Code 69367-272-04 is assigned to a package of 118 ml in 1 bottle of Codeine-guaifenesin, a human over the counter drug labeled by Westminster Pharmaceuticals, Llc. The product's dosage form is solution and is administered via oral form.

    Is NDC 69367-272 included in the NDC Directory?

    Yes, Codeine-guaifenesin with product code 69367-272 is active and included in the NDC Directory. The product was first marketed by Westminster Pharmaceuticals, Llc on July 15, 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 11-digit format for NDC 69367-272-04?

    The 11-digit format is 69367027204. 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
    5-3-269367-272-045-4-269367-0272-04