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  5. NDC Package Code: 58602-426-20 Fexofenadine Hydrochloride

NDC Package 58602-426-20 Fexofenadine Hydrochloride

Fexofenadine Hydrochloride Oral Suspension Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

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:
58602-426-20
Package Description:
1 BOTTLE in 1 CARTON / 240 mL in 1 BOTTLE
Product Code:
58602-426
Proprietary Name:
Fexofenadine Hydrochloride
Non-Proprietary Name:
Fexofenadine Hydrochloride Oral
Substance Name:
Fexofenadine Hydrochloride
Usage Information:
Shake well before usinguse only with enclosed dosing cupadults and children 12 years of age and overtake 10 mL every 12 hours; do not take more than 20 mL in 24 hourschildren 2 to under 12 years of agetake 5 mL every 12 hours; do not take more than 10 mL in 24 hourschildren under 2 years of ageask a doctoradults 65 years of age and olderask a doctorconsumers with kidney diseaseask a doctorNote: mL = milliliters
11-Digit NDC Billing Format:
58602042620
NDC to RxNorm Crosswalk:
  • RxCUI: 997491 - fexofenadine HCl 30 MG in 5 mL Oral Suspension
  • RxCUI: 997491 - fexofenadine hydrochloride 6 MG/ML Oral Suspension
  • RxCUI: 997491 - fexofenadine HCl 30 MG per 5 ML Oral Suspension
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Aurohealth Llc
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • FEXOFENADINE HYDROCHLORIDE 30 mg/5mL
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA213466
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-23-2023
    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
    58602-426-241 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58602-426-20?

    The NDC Packaged Code 58602-426-20 is assigned to a package of 1 bottle in 1 carton / 240 ml in 1 bottle of Fexofenadine Hydrochloride, a human over the counter drug labeled by Aurohealth Llc. The product's dosage form is suspension and is administered via oral form.

    Is NDC 58602-426 included in the NDC Directory?

    Yes, Fexofenadine Hydrochloride with product code 58602-426 is active and included in the NDC Directory. The product was first marketed by Aurohealth Llc on May 23, 2023 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 58602-426-20?

    The 11-digit format is 58602042620. 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
    5-3-258602-426-205-4-258602-0426-20