1. Home
  2. Labeler Index
  3. Aurohealth Llc
  4. 58602-844
  5. NDC Package Code: 58602-844-60 Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride

NDC Package 58602-844-60 Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride

Tablet, Film Coated, Extended Release 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:
58602-844-60
Package Description:
1 BLISTER PACK in 1 CARTON / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
58602-844
Proprietary Name:
Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride
Non-Proprietary Name:
Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride
Substance Name:
Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride
Usage Information:
Do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 24 hours on an empty stomach; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctorOther informationsafety sealed: do not use if carton is opened or if individual blister units are torn or openedstore between 20° and 25°C (68° and 77°F)FDA approved dissolution test specifications differ from USP
11-Digit NDC Billing Format:
58602084460
NDC to RxNorm Crosswalk:
  • RxCUI: 997415 - fexofenadine HCl 180 MG / pseudoephedrine HCl 240 MG 24HR Extended Release Oral Tablet
  • RxCUI: 997415 - 24 HR fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG Extended Release Oral Tablet
  • RxCUI: 997415 - fexofenadine hydrochloride 180 MG / pseudoephedrine hydrochloride 240 MG 24 HR Extended Release Oral Tablet
Product Type:
Human Otc Drug
Labeler Name:
Aurohealth Llc
Dosage Form:
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA215232
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
04-17-2025
Listing Expiration Date:
12-31-2026
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
58602-844-662 BLISTER PACK in 1 CARTON / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
58602-844-853 BLISTER PACK in 1 CARTON / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 58602-844-60?

The NDC Packaged Code 58602-844-60 is assigned to a package of 1 blister pack in 1 carton / 5 tablet, film coated, extended release in 1 blister pack of Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride, a human over the counter drug labeled by Aurohealth Llc. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Is NDC 58602-844 included in the NDC Directory?

Yes, Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride with product code 58602-844 is active and included in the NDC Directory. The product was first marketed by Aurohealth Llc on April 17, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 58602-844-60?

The 11-digit format is 58602084460. 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
5-3-258602-844-605-4-258602-0844-60