Cetirizine Hydrochloride (allergy) Capsule
NDC Package 21130-099-97

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cetirizine Hydrochloride (allergy) (cetirizine hydrochloride) capsules is adults and children6 years and overone 10 mg capsule once daily;do not take more than one 10 mgcapsule in 24 hours. This formulation utilizes a capsule delivery system. Marketed by Better Living Brands, Llc, this product is identified by NDC 21130-099 and is authorized under FDA application ANDA209107.

Identification & Billing

NDC Package Code
21130-099-97
Package Description
1 BOTTLE in 1 CARTON / 25 CAPSULE in 1 BOTTLE
Product Code
21130-099
11-Digit Billing Format
21130009997
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetirizine Hydrochloride (allergy)
Non-Proprietary Name
Cetirizine Hydrochloride
Substance Name
Cetirizine Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CETIRIZINE HYDROCHLORIDE 10 mg/1
Pharmacologic Class
Usage Information
Adults and children6 years and overone 10 mg capsule once daily;do not take more than one 10 mgcapsule in 24 hours. A 5 mgproduct may be appropriate forless severe symptoms.adults 65 years and overask a doctorchildren under 6 years of ageask a doctorconsumers with liver orkidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Better Living Brands, Llc
Product Type
Human Otc Drug
FDA Application #
ANDA209107
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-15-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 21130-099-97 identifies a specific commercial package of 1 bottle in 1 carton / 25 capsule in 1 bottle of Cetirizine Hydrochloride (allergy), a human over the counter drug labeled by Better Living Brands, Llc. This capsule 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 Better Living Brands, Llc on November 15, 2023. The current certification is valid through December 31, 2026.

How is this Better Living Brands, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21130009997. 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)
21130-099-97
11-Digit CMS (5-4-2)
21130-0099-97

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