Hydroxyzine Hydrochloride
NDC Package 52959-481-06

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Hydroxyzine Hydrochloride is oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride.Hydroxyzine is contraindicated in patients with a prolonged QT interval.Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Marketed by H.j Harkins Company Inc., this product is identified by NDC 52959-481 and is authorized under FDA application ANDA204279.

Identification & Billing

NDC Package Code
52959-481-06
Package Description
6 TABLET in 1 CONTAINER
Product Code
52959-481
11-Digit Billing Format
52959048106
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hydroxyzine Hydrochloride
Dosage Form
-
Usage Information
Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride.Hydroxyzine is contraindicated in patients with a prolonged QT interval.Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.

Regulatory & Marketing

Labeler Name
H.j Harkins Company Inc.
FDA Application #
ANDA204279
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-03-2017
Listing Expiration
12-31-2019
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (52959-481). Click a package code to view its specific billing and regulatory data.

52959-481-10
10 TABLET in 1 CONTAINER
52959-481-12
12 TABLET in 1 CONTAINER
52959-481-15
15 TABLET in 1 CONTAINER
52959-481-20
20 TABLET in 1 CONTAINER
52959-481-25
25 TABLET in 1 CONTAINER
52959-481-30
30 TABLET in 1 CONTAINER
52959-481-60
60 TABLET in 1 CONTAINER

* 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 52959-481-06 identifies a specific commercial package of 6 tablet in 1 container of Hydroxyzine Hydrochloride, labeled by H.j Harkins Company Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by H.j Harkins Company Inc. on January 03, 2017. The current certification is valid through December 31, 2019.

How is this H.j Harkins Company Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52959048106. 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)
52959-481-06
11-Digit CMS (5-4-2)
52959-0481-06

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