Cetirizine Hydrochloride Tablet
NDC Package 69848-006-09

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

Package Information

Cetirizine Hydrochloride tablets is adults and children 6 years and over- one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. This formulation utilizes a tablet delivery system. Marketed by Granules Usa, Inc., this product is identified by NDC 69848-006 and is authorized under FDA application ANDA209274.

Identification & Billing

NDC Package Code
69848-006-09
Package Description
90 TABLET in 1 BOTTLE
Product Code
69848-006
11-Digit Billing Format
69848000609
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetirizine Hydrochloride
Non-Proprietary Name
Cetirizine Hydrochloride
Substance Name
Cetirizine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
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 children 6 years and over- one 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 doctor children under 6 years of age - ask a doctor consumers with liver or kidney disease - ask a doctor

Regulatory & Marketing

Labeler Name
Granules Usa, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA209274
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-30-2021
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 69848-006-09 identifies a specific commercial package of 90 tablet in 1 bottle of Cetirizine Hydrochloride, a human over the counter drug labeled by Granules Usa, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 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 Granules Usa, Inc. on June 30, 2021. The current certification is valid through December 31, 2026.

How is this Granules Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69848000609. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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)
69848-006-09
11-Digit CMS (5-4-2)
69848-0006-09

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