Cetirizine Dihydrochloride Powder
NDC Package 51604-0021-0

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Cetirizine Dihydrochloride powders is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a powder delivery system. Marketed by Cosma Spa, this product is identified by NDC 51604-0021.

Identification & Billing

NDC Package Code
51604-0021-0
Package Description
40 kg in 1 DRUM
Product Code
51604-0021
11-Digit Billing Format
51604002100

Clinical Specifications

Proprietary Name
Cetirizine Dihydrochloride
Non-Proprietary Name
Cetirizine Dihydrochloride
Substance Name
Cetirizine Dihydrochloride, (s)-
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
CETIRIZINE DIHYDROCHLORIDE, (S)- 1 kg/kg

Regulatory & Marketing

Labeler Name
Cosma Spa
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
11-26-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 51604-0021-0 identifies a specific commercial package of 40 kg in 1 drum of Cetirizine Dihydrochloride (UNFINISHED drug), a bulk ingredient labeled by Cosma Spa. This powder is formulated for use and contains cetirizine dihydrochloride, (s)- 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 Cosma Spa on November 26, 2018. The current certification is valid through December 31, 2026.

How is this Cosma Spa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51604002100. 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 (5-4-1)
51604-0021-0
11-Digit CMS (5-4-2)
51604-0021-00

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