Allergy Relief Capsule, Coated
NDC Package 69168-413-06

11-digit billing NDC: 69168041306
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Allergy Relief (fexofenadine hcl) capsules is adults and children 12 years of age and over  take one 180 mg caplet with water, once a day; do not take more than 1 caplet in 24 hours Children under 12 years of age do not useAdults 65 years of age and older ask a doctor Consumers with kidney disease  ask a doctor. This formulation utilizes a capsule, coated delivery system. Marketed by Allegiant Health, this product is identified by NDC 69168-413 and is authorized under FDA application ANDA211075.

Identification & Billing

NDC Package Code
69168-413-06
Package Description
120 CAPSULE, COATED in 1 BOTTLE
Product Code
69168-413
11-Digit Billing Format
69168041306

Clinical Specifications

Proprietary Name
Allergy Relief
Non-Proprietary Name
Fexofenadine Hcl
Substance Name
Fexofenadine Hydrochloride
Dosage Form
Capsule, Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in 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 over  take one 180 mg caplet with water, once a day; do not take more than 1 caplet in 24 hours Children under 12 years of age do not useAdults 65 years of age and older ask a doctor Consumers with kidney disease  ask a doctor

Regulatory & Marketing

Labeler Name
Allegiant Health
Product Type
Human Otc Drug
FDA Application #
ANDA211075
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-22-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69168-413). Click a package code to view its specific billing and regulatory data.

69168-413-03
3 CAPSULE, COATED in 1 CARTON
69168-413-14
250 CAPSULE, COATED in 1 BOTTLE
69168-413-30
30 CAPSULE, COATED in 1 BOTTLE
69168-413-80
180 CAPSULE, COATED in 1 BOTTLE
69168-413-82
90 CAPSULE, COATED in 1 BOTTLE

* 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 69168-413-06 identifies a specific commercial package of 120 capsule, coated in 1 bottle of Allergy Relief, a human over the counter drug labeled by Allegiant Health. This capsule, 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 Allegiant Health on March 22, 2021. The current certification is valid through December 31, 2027.

How is this Allegiant Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69168041306. 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)
69168-413-06
11-Digit CMS (5-4-2)
69168-0413-06

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