Guaiatussin Ac
NDC Package 50383-087-07

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

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

Guaiatussin Ac 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 over2 teaspoonfulschildren 6 to under 12 years of age1 teaspoonfulchildren under 6 years of ageConsult a doctor. Marketed by Akorn Operating Company Llc, this product is identified by NDC 50383-087 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
50383-087-07
Package Description
10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (50383-087-05)
Product Code
50383-087
11-Digit Billing Format
50383008707
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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
Guaiatussin Ac Sugar Free
Dosage Form
-
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 over2 teaspoonfulschildren 6 to under 12 years of age1 teaspoonfulchildren under 6 years of ageConsult a doctor

Regulatory & Marketing

Labeler Name
Akorn Operating Company Llc
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
09-08-2010
Listing Expiration
12-31-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50383-087). Click a package code to view its specific billing and regulatory data.

50383-087-04
118 mL in 1 BOTTLE
50383-087-12
10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (50383-087-10)
50383-087-16
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 50383-087-07 identifies a specific commercial package of 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose (50383-087-05) of Guaiatussin Ac Sugar Free, labeled by Akorn Operating Company Llc. 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 Akorn Operating Company Llc on September 08, 2010. The current certification is valid through December 31, 2023.

How is this Akorn Operating Company Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50383008707. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
50383-087-07
11-Digit CMS (5-4-2)
50383-0087-07

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