Hydroxyzine Pamoate
NDC Package 42495-170-30

11-digit billing NDC: 42495017030
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 inactivated by the FDA.

Hydroxyzine Pamoate is  For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Marketed by Westwood Manufacturing, this product is identified by NDC 42495-170 and is authorized under FDA application ANDA201507.

Identification & Billing

NDC Package Code
42495-170-30
Package Description
30 CAPSULE in 1 BLISTER PACK
Product Code
42495-170
11-Digit Billing Format
42495017030
RxNorm Crosswalk
  • RxCUI: 995278 - hydrOXYzine pamoate 50 MG Oral Capsule
  • RxCUI: 995278 - hydroxyzine pamoate 50 MG Oral Capsule
  • RxCUI: 995278 - hydroxyzine pamoate 50 MG (hydroxyzine pamoate 85.2 MG eqv to hydroxyzine HCl 50 MG) Oral Capsule

Clinical Specifications

Proprietary Name
Hydroxyzine Pamoate
Dosage Form
-
Usage Information
 For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

Regulatory & Marketing

Labeler Name
Westwood Manufacturing
FDA Application #
ANDA201507
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-17-2010
Listing Expiration
12-31-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42495-170-30 identifies a specific commercial package of 30 capsule in 1 blister pack of Hydroxyzine Pamoate, labeled by Westwood Manufacturing. 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 Westwood Manufacturing on November 17, 2010. The current certification is valid through December 31, 2017.

How is this Westwood Manufacturing product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42495017030. 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)
42495-170-30
11-Digit CMS (5-4-2)
42495-0170-30

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