Levocetirizine Dihydrochloride Powder
NDC Package 49574-521-01

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.

Levocetirizine Dihydrochloride powders is levocetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing. This formulation utilizes a powder delivery system. Marketed by Hunan Jiudian Pharmaceutical Co.,ltd., this product is identified by NDC 49574-521.

Identification & Billing

NDC Package Code
49574-521-01
Package Description
25 kg in 1 DRUM
Product Code
49574-521
11-Digit Billing Format
49574052101

Clinical Specifications

Proprietary Name
Levocetirizine Dihydrochloride
Non-Proprietary Name
Levocetirizine Dihydrochloride
Substance Name
Levocetirizine Dihydrochloride
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)
LEVOCETIRIZINE DIHYDROCHLORIDE 1 kg/kg
Usage Information
Levocetirizine is an antihistamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing. It is also used to relieve itching and hives. It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Levocetirizine does not prevent hives or prevent/treat a serious allergic reaction (such as anaphylaxis). If your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use levocetirizine in place of your epinephrine.

Regulatory & Marketing

Labeler Name
Hunan Jiudian Pharmaceutical Co.,ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
06-01-2019
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 49574-521-01 identifies a specific commercial package of 25 kg in 1 drum of Levocetirizine Dihydrochloride (UNFINISHED drug), a bulk ingredient labeled by Hunan Jiudian Pharmaceutical Co.,ltd.. This powder is formulated for use and contains levocetirizine dihydrochloride 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 Hunan Jiudian Pharmaceutical Co.,ltd. on June 01, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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

How is this Hunan Jiudian Pharmaceutical Co.,ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49574052101. 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)
49574-521-01
11-Digit CMS (5-4-2)
49574-0521-01

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