Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride Tablet, Film Coated, Extended Release
NDC Package 58602-703-76

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

Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride tablets is do not break or chew tablet; swallow tablet wholeadults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and overask a doctorchildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Aurohealth Llc, this product is identified by NDC 58602-703 and is authorized under FDA application ANDA212409.

Identification & Billing

NDC Package Code
58602-703-76
Package Description
4 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
58602-703
11-Digit Billing Format
58602070376
RxNorm Crosswalk
  • RxCUI: 1014571 - cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1014571 - 12 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
  • RxCUI: 1014571 - cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride
Non-Proprietary Name
Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride
Substance Name
Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not break or chew tablet; swallow tablet wholeadults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and overask a doctorchildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Aurohealth Llc
Product Type
Human Otc Drug
FDA Application #
ANDA212409
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-08-2023
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 (58602-703). Click a package code to view its specific billing and regulatory data.

58602-703-09
12 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
58602-703-53
12 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
58602-703-75
2 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED, 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 58602-703-76 identifies a specific commercial package of 4 blister pack in 1 carton / 6 tablet, film coated, extended release in 1 blister pack of Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride, a human over the counter drug labeled by Aurohealth Llc. This tablet, film coated, extended release is formulated for oral use and contains cetirizine hydrochloride; pseudoephedrine hydrochloride 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 March 08, 2023. The current certification is valid through December 31, 2026.

How is this Aurohealth Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58602070376. 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)
58602-703-76
11-Digit CMS (5-4-2)
58602-0703-76

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