Codeine-guaifenesin Solution
NDC Package 69367-272-16

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Codeine-guaifenesin (codeine phosphate and guaifenesin) solution is 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. This formulation utilizes a solution delivery system. Marketed by Westminster Pharmaceuticals, Llc, this product is identified by NDC 69367-272 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
69367-272-16
Package Description
473 mL in 1 BOTTLE
Product Code
69367-272
11-Digit Billing Format
69367027216
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

Clinical Specifications

Proprietary Name
Codeine-guaifenesin
Non-Proprietary Name
Codeine Phosphate And Guaifenesin
Substance Name
Codeine Phosphate; Guaifenesin
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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.
DEA Schedule
Schedule V (CV) Substances

Regulatory & Marketing

Labeler Name
Westminster Pharmaceuticals, Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-15-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69367-272). Click a package code to view its specific billing and regulatory data.

69367-272-04
118 mL in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69367-272-16 identifies a specific commercial package of 473 ml in 1 bottle of Codeine-guaifenesin, a human over the counter drug labeled by Westminster Pharmaceuticals, Llc. This solution is formulated for oral use and contains codeine phosphate; guaifenesin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Westminster Pharmaceuticals, Llc on July 15, 2020. The current certification is valid through December 31, 2026.

How is this Westminster Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69367027216. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
69367-272-16
11-Digit CMS (5-4-2)
69367-0272-16

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.