Codeine-guaifenesin Solution
NDC Package 68071-5173-4

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-5173 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
68071-5173-4
Package Description
120 mL in 1 BOTTLE
Product Code
68071-5173
11-Digit Billing Format
68071517304
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
Nucare Pharmaceuticals,inc.
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-01-2014
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68071-5173-4 identifies a specific commercial package of 120 ml in 1 bottle of Codeine-guaifenesin, a human over the counter drug labeled by Nucare Pharmaceuticals,inc.. 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 Nucare Pharmaceuticals,inc. on April 01, 2014. The current certification is valid through December 31, 2026.

How is this Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071517304. 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 (5-4-1)
68071-5173-4
11-Digit CMS (5-4-2)
68071-5173-04

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