Hydroxyzine Hydrochloride Tablet, Film Coated
NDC Package 10135-810-01

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

Hydroxyzine Hydrochloride tablets is for symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. This formulation utilizes a tablet, film coated delivery system. Marketed by Marlex Pharmaceuticals, Inc., this product is identified by NDC 10135-810 and is authorized under FDA application ANDA207121.

Identification & Billing

NDC Package Code
10135-810-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
10135-810
11-Digit Billing Format
10135081001
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
Non-Proprietary Name
Hydroxyzine Hydrochloride
Substance Name
Hydroxyzine Dihydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HYDROXYZINE DIHYDROCHLORIDE 10 mg/1
Pharmacologic Class
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
Marlex Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207121
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2025
Listing Expiration
12-31-2026
Exclude Flag
N
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 (10135-810). Click a package code to view its specific billing and regulatory data.

10135-810-10
1000 TABLET, FILM COATED in 1 BOTTLE

* 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 10135-810-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Hydroxyzine Hydrochloride, a human prescription drug labeled by Marlex Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet, film coated is formulated for oral use and contains hydroxyzine 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 Marlex Pharmaceuticals, Inc. on March 01, 2025. The current certification is valid through December 31, 2026.

How is this Marlex Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135081001. 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)
10135-810-01
11-Digit CMS (5-4-2)
10135-0810-01

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