Guaifenesin Tablet, Extended Release
NDC Package 58602-810-96

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 tablets is a medication used for the temporary relief of coughs caused by the common cold, bronchitis, and other breathing illnesses. This formulation utilizes a tablet, extended release delivery system. Marketed by Aurohealth Llc, this product is identified by NDC 58602-810 and is authorized under FDA application ANDA210453.

Identification & Billing

NDC Package Code
58602-810-96
Package Description
1 BLISTER PACK in 1 CARTON / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
58602-810
11-Digit Billing Format
58602081096
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
This medication is used for the temporary relief of coughs caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. This product (sustained-release) is not recommended for use in children younger than 12 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold. To decrease the risk for side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Regulatory & Marketing

Labeler Name
Aurohealth Llc
Product Type
Human Otc Drug
FDA Application #
ANDA210453
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-21-2019
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 (58602-810). Click a package code to view its specific billing and regulatory data.

58602-810-12
1 BOTTLE in 1 CARTON / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE
58602-810-21
1 BOTTLE in 1 CARTON / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
58602-810-38
8 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
58602-810-73
1 BOTTLE in 1 CARTON / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE
58602-810-97
2 BLISTER PACK in 1 CARTON / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
58602-810-98
5 BLISTER PACK in 1 CARTON / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

* 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 58602-810-96 identifies a specific commercial package of 1 blister pack in 1 carton / 20 tablet, extended release in 1 blister pack of Guaifenesin, a human over the counter drug labeled by Aurohealth Llc. 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 Aurohealth Llc on October 21, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used for the temporary relief of coughs caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. This product (sustained-release) is not recommended for use in children younger than 12 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold. To decrease the risk for side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

How is this Aurohealth Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58602081096. 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)
58602-810-96
11-Digit CMS (5-4-2)
58602-0810-96

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