Guaifenesin And Codeine Phosphate
NDC Package 68071-2935-4

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Guaifenesin And Codeine Phosphate 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. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-2935 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
68071-2935-4
Package Description
118 mL in 1 BOTTLE
Product Code
68071-2935
11-Digit Billing Format
68071293504
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
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals,inc.
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
05-23-2022
Listing Expiration
12-31-2024
Exclude Flag
I
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 68071-2935-4 identifies a specific commercial package of 118 ml in 1 bottle of Guaifenesin And Codeine Phosphate, labeled by Nucare Pharmaceuticals,inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Nucare Pharmaceuticals,inc. on May 23, 2022. The current certification is valid through December 31, 2024.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071293504. 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)
68071-2935-4
11-Digit CMS (5-4-2)
68071-2935-04

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