Allergy Relief Tablet, Coated
NDC Package 81522-613-30

11-digit billing NDC: 81522061330
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Allergy Relief (fexofenadine hcl) tablets is adults and children 12 years of age and overtake one 180 mg tablet with water once a day;do not take more than 1 tablet in 24 hourschildren under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor . This formulation utilizes a tablet, coated delivery system. Marketed by Fsa Store Inc. (caring Mills), this product is identified by NDC 81522-613 and is authorized under FDA application ANDA211075.

Identification & Billing

NDC Package Code
81522-613-30
Package Description
1 BOTTLE, PLASTIC in 1 BOX / 30 TABLET, COATED in 1 BOTTLE, PLASTIC
Product Code
81522-613
11-Digit Billing Format
81522061330
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Allergy Relief
Non-Proprietary Name
Fexofenadine Hcl
Substance Name
Fexofenadine Hydrochloride
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FEXOFENADINE HYDROCHLORIDE 180 mg/1
Pharmacologic Class
Usage Information
Adults and children 12 years of age and overtake one 180 mg tablet with water once a day;do not take more than 1 tablet in 24 hourschildren under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor 

Regulatory & Marketing

Labeler Name
Fsa Store Inc. (caring Mills)
Product Type
Human Otc Drug
FDA Application #
ANDA211075
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-08-2021
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 81522-613-30 identifies a specific commercial package of 1 bottle, plastic in 1 box / 30 tablet, coated in 1 bottle, plastic of Allergy Relief, a human over the counter drug labeled by Fsa Store Inc. (caring Mills). This tablet, coated is formulated for oral use and contains fexofenadine 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 Fsa Store Inc. (caring Mills) on October 08, 2021. The current certification is valid through December 31, 2027.

How is this Fsa Store Inc. (caring Mills) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81522061330. 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)
81522-613-30
11-Digit CMS (5-4-2)
81522-0613-30

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