Hydroxyzine Hydrochloride
NDC Package 60687-686-01

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

Hydroxyzine Hydrochloride 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 a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Marketed by American Health Packaging, this product is identified by NDC 60687-686 and is authorized under FDA application ANDA088619.

Identification & Billing

NDC Package Code
60687-686-01
Package Description
100 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-686-11)
Product Code
60687-686
11-Digit Billing Format
60687068601
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hydroxyzine Hydrochloride
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 a premedication and following general anesthesia, hydroxyzine may potentiate meperidine 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
American Health Packaging
FDA Application #
ANDA088619
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-06-2022
End Marketing Date
11-30-2024
Listing Expiration
11-30-2024
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 60687-686-01 identifies a specific commercial package of 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack (60687-686-11) of Hydroxyzine Hydrochloride, labeled by American Health Packaging. 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 American Health Packaging on October 06, 2022. The current certification is valid through November 30, 2024.

How is this American Health Packaging product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60687068601. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
60687-686-01
11-Digit CMS (5-4-2)
60687-0686-01

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