Guaifenesin Tablet, Extended Release
NDC Package 82804-265-20

11-digit billing NDC: 82804026520
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Guaifenesin tablets is •do not crush, chew, or break tablet•take with a full glass of water•this product can be administered without regard for timing of meals•adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. This formulation utilizes a tablet, extended release delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 82804-265 and is authorized under FDA application ANDA213420.

Identification & Billing

NDC Package Code
82804-265-20
Package Description
20 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
82804-265
11-Digit Billing Format
82804026520
RxNorm Crosswalk
  • RxCUI: 636522 - guaiFENesin 600 MG 12HR Extended Release Oral Tablet
  • RxCUI: 636522 - 12 HR guaifenesin 600 MG Extended Release Oral Tablet
  • RxCUI: 636522 - guaifenesin 600 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Guaifenesin
Non-Proprietary Name
Guaifenesin
Substance Name
Guaifenesin
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GUAIFENESIN 600 mg/1
Pharmacologic Class
Usage Information
•do not crush, chew, or break tablet•take with a full glass of water•this product can be administered without regard for timing of meals•adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours(For 600mg)•children under 12 years of age: do not use

Regulatory & Marketing

Labeler Name
Proficient Rx Lp
Product Type
Human Otc Drug
FDA Application #
ANDA213420
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-19-2022
Listing Expiration
12-31-2027
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 82804-265-20 identifies a specific commercial package of 20 tablet, extended release in 1 bottle of Guaifenesin, a human over the counter drug labeled by Proficient Rx Lp. This tablet, extended release is formulated for oral use and contains 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 Proficient Rx Lp on August 19, 2022. The current certification is valid through December 31, 2027.

How is this Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82804026520. 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)
82804-265-20
11-Digit CMS (5-4-2)
82804-0265-20

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