Guaifenesin And Codeine Phosphate Solution
NDC Package 0121-0775-08

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

Guaifenesin And Codeine Phosphate solution is take every 4 hoursdo not exceed 6 doses in 24 hoursa special measuring device should be used to give an accurate dose of this product to children under 6 years of agegiving a higher dose than recommended by a doctor can result in serious side effects for a childadults and children 12 years and over10 mL (2 teaspoonfuls)children 6 to under 12 years of age5 mL (1 teaspoonful)children under 6 years of ageConsult a doctor. This formulation utilizes a solution delivery system. Marketed by Pai Holdings, Llc, this product is identified by NDC 0121-0775 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0121-0775-08
Package Description
237 mL in 1 BOTTLE
Product Code
0121-0775
11-Digit Billing Format
00121077508
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
237 ML
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
Guaifenesin And Codeine Phosphate
Non-Proprietary Name
Guaifenesin And Codeine Phosphate
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
Take every 4 hoursdo not exceed 6 doses in 24 hoursa special measuring device should be used to give an accurate dose of this product to children under 6 years of agegiving a higher dose than recommended by a doctor can result in serious side effects for a childadults and children 12 years and over10 mL (2 teaspoonfuls)children 6 to under 12 years of age5 mL (1 teaspoonful)children under 6 years of ageConsult a doctor
DEA Schedule
Schedule V (CV) Substances

Regulatory & Marketing

Labeler Name
Pai Holdings, Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-01-2006
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 (0121-0775). Click a package code to view its specific billing and regulatory data.

0121-0775-04
118 mL in 1 BOTTLE
0121-0775-16
473 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 0121-0775-08 identifies a specific commercial package of 237 ml in 1 bottle of Guaifenesin And Codeine Phosphate, a human over the counter drug labeled by Pai Holdings, 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 Pai Holdings, Llc on October 01, 2006. The current certification is valid through December 31, 2026.

How is this Pai Holdings, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121077508. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 237 total billable units per package. 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 (4-4-2)
0121-0775-08
11-Digit CMS (5-4-2)
00121-0775-08

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