Cetirizine Hcl Capsule
NDC Package 46122-613-63

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

Package Information

Cetirizine Hcl capsules is cetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. This formulation utilizes a capsule delivery system. Marketed by Amerisource Bergen, this product is identified by NDC 46122-613 and is authorized under FDA application NDA022429.

Identification & Billing

NDC Package Code
46122-613-63
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 25 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
46122-613
11-Digit Billing Format
46122061363
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetirizine Hcl
Non-Proprietary Name
Cetirizine Hcl
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
Cetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Cetirizine does not prevent hives or prevent/treat a serious allergic reaction (such as anaphylaxis). Therefore, if your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use cetirizine in place of your epinephrine.

Regulatory & Marketing

Labeler Name
Amerisource Bergen
Product Type
Human Otc Drug
FDA Application #
NDA022429
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-18-2019
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 46122-613-63 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 25 capsule in 1 bottle, plastic of Cetirizine Hcl, a human over the counter drug labeled by Amerisource Bergen. 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 Amerisource Bergen on June 18, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Cetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Cetirizine does not prevent hives or prevent/treat a serious allergic reaction (such as anaphylaxis). Therefore, if your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use cetirizine in place of your epinephrine.

How is this Amerisource Bergen product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46122061363. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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:

10-Digit Format (5-3-2)
46122-613-63
11-Digit CMS (5-4-2)
46122-0613-63

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