Hydroxyzine Pamoate Capsule
NDC Package 71335-3003-1

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

Package Information

Hydroxyzine Pamoate capsules is hydroxyzine is used to treat itching caused by allergies. This formulation utilizes a capsule delivery system. Marketed by Bryant Ranch Prepack, this product is identified by NDC 71335-3003 and is authorized under FDA application ANDA087479.

Identification & Billing

NDC Package Code
71335-3003-1
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
71335-3003
11-Digit Billing Format
71335300301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hydroxyzine Pamoate
Non-Proprietary Name
Hydroxyzine Pamoate
Substance Name
Hydroxyzine Pamoate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HYDROXYZINE PAMOATE 25 mg/1
Pharmacologic Class
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
Bryant Ranch Prepack
Product Type
Human Prescription Drug
FDA Application #
ANDA087479
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-14-1981
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71335-3003-1 identifies a specific commercial package of 30 capsule in 1 bottle of Hydroxyzine Pamoate, a human prescription drug labeled by Bryant Ranch Prepack. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This capsule is formulated for oral use and contains hydroxyzine pamoate 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 Bryant Ranch Prepack on December 14, 1981. The current certification is valid through December 31, 2026.

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 Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71335300301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (5-4-1)
71335-3003-1
11-Digit CMS (5-4-2)
71335-3003-01

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