Hydroxyzine Hcl
NDC Package 54879-006-16

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Hydroxyzine Hcl is hydroxyzine is used to treat itching caused by allergies. Marketed by Sti Pharma Llc, this product is identified by NDC 54879-006 and is authorized under FDA application ANDA086880.

Identification & Billing

NDC Package Code
54879-006-16
Package Description
473 mL in 1 BOTTLE
Product Code
54879-006
11-Digit Billing Format
54879000616

Clinical Specifications

Proprietary Name
Hydroxyzine Hcl
Dosage Form
-
Usage Information
Hydroxyzine is used to treat itching caused by allergies. It is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Hydroxyzine may also be used short-term to treat anxiety or to help you feel sleepy/relaxed before and after surgery.

Regulatory & Marketing

Labeler Name
Sti Pharma Llc
FDA Application #
ANDA086880
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-1982
End Marketing Date
01-01-2022
Listing Expiration
01-01-2022
Exclude Flag
D
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 54879-006-16 identifies a specific commercial package of 473 ml in 1 bottle of Hydroxyzine Hcl, labeled by Sti Pharma Llc. 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 Sti Pharma Llc on January 01, 1982. The current certification is valid through January 01, 2022.

What are the primary indications for this medication?

Hydroxyzine is used to treat itching caused by allergies. It is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Hydroxyzine may also be used short-term to treat anxiety or to help you feel sleepy/relaxed before and after surgery.

How is this Sti Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54879000616. 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)
54879-006-16
11-Digit CMS (5-4-2)
54879-0006-16

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