NDC Package 58602-811-57 Guaifenesin

Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
58602-811-57
Package Description:
1 BOTTLE in 1 CARTON / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Guaifenesin
Non-Proprietary Name:
Guaifenesin
Substance Name:
Guaifenesin
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).
11-Digit NDC Billing Format:
58602081157
NDC to RxNorm Crosswalk:
  • RxCUI: 310621 - guaiFENesin 1200 MG 12HR Extended Release Oral Tablet
  • RxCUI: 310621 - 12 HR guaifenesin 1200 MG Extended Release Oral Tablet
  • RxCUI: 310621 - guaifenesin 1200 MG 12 HR Extended Release Oral Tablet
  • Product Type:
    Human Otc Drug
    Labeler Name:
    Aurohealth Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA210453
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-21-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    58602-811-011 BLISTER PACK in 1 CARTON / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
    58602-811-022 BLISTER PACK in 1 CARTON / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
    58602-811-033 BLISTER PACK in 1 CARTON / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
    58602-811-051 BOTTLE in 1 CARTON / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE
    58602-811-121 BOTTLE in 1 CARTON / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE
    58602-811-21100 TABLET, EXTENDED RELEASE in 1 BOTTLE
    58602-811-564 BLISTER PACK in 1 CARTON / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
    58602-811-601 BOTTLE in 1 CARTON / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE
    58602-811-641 BLISTER PACK in 1 CARTON / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
    58602-811-731 BOTTLE in 1 CARTON / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58602-811-57?

    The NDC Packaged Code 58602-811-57 is assigned to a package of 1 bottle in 1 carton / 28 tablet, extended release in 1 bottle of Guaifenesin, a human over the counter drug labeled by Aurohealth Llc. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 58602-811 included in the NDC Directory?

    Yes, Guaifenesin with product code 58602-811 is active and included in the NDC Directory. The product was first marketed by Aurohealth Llc on October 21, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 58602-811-57?

    The 11-digit format is 58602081157. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-258602-811-575-4-258602-0811-57