Cetirizine Hydrochloride (allergy) Tablet
NDC Package 58602-445-40
Package Information
Cetirizine Hydrochloride (allergy) (cetirizine hydrochloride) tablets is for 5 mg:adults and children 6 years and over1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hourschildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctorFor 10 mg:adults and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.adults 65 years and over ask a doctorchildren under 6 years of age ask a doctorconsumers with liver or kidney diseaseask a doctor. This formulation utilizes a tablet delivery system. Marketed by Aurohealth Llc, this product is identified by NDC 58602-445 and is authorized under FDA application ANDA090760.
Identification & Billing
- RxCUI: 1014676 - cetirizine HCl 5 MG Oral Tablet
- RxCUI: 1014676 - cetirizine hydrochloride 5 MG Oral Tablet
- RxCUI: 1014678 - cetirizine HCl 10 MG Oral Tablet
- RxCUI: 1014678 - cetirizine hydrochloride 10 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 58602 - Aurohealth Llc
- 58602-445 - Cetirizine Hydrochloride (allergy)
- 58602-445-40 - 500 TABLET in 1 BOTTLE
- 58602-445 - Cetirizine Hydrochloride (allergy)
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 (58602-445). Click a package code to view its specific billing and regulatory data.
* 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 58602-445-40 identifies a specific commercial package of 500 tablet in 1 bottle of Cetirizine Hydrochloride (allergy), a human over the counter drug labeled by Aurohealth Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 500 billable units per package. This tablet is formulated for oral use and contains cetirizine 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 August 05, 2015. 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: 58602044540. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 total billable units per package. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
