Hydroxyzine Hydrochloride Solution
NDC Package 71656-090-16

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

Package Information

Hydroxyzine Hydrochloride solution 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 meperidineand 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. This formulation utilizes a solution delivery system. Marketed by Saptalis Pharmaceuticals, Llc., this product is identified by NDC 71656-090 and is authorized under FDA application ANDA220271.

Identification & Billing

NDC Package Code
71656-090-16
Package Description
473 mL in 1 BOTTLE
Product Code
71656-090
11-Digit Billing Format
71656009016

Clinical Specifications

Proprietary Name
Hydroxyzine Hydrochloride
Non-Proprietary Name
Hydroxyzine Hydrochloride
Substance Name
Hydroxyzine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HYDROXYZINE HYDROCHLORIDE 10 mg/5mL
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 premedication and following general anesthesia, hydroxyzine may potentiate meperidineand 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
Saptalis Pharmaceuticals, Llc.
Product Type
Human Prescription Drug
FDA Application #
ANDA220271
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-17-2026
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71656-090-16 identifies a specific commercial package of 473 ml in 1 bottle of Hydroxyzine Hydrochloride, a human prescription drug labeled by Saptalis Pharmaceuticals, Llc.. This solution is formulated for oral use and contains hydroxyzine hydrochloride 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 Saptalis Pharmaceuticals, Llc. on June 17, 2026. The current certification is valid through December 31, 2027.

How is this Saptalis Pharmaceuticals, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71656009016. 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)
71656-090-16
11-Digit CMS (5-4-2)
71656-0090-16

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