Loxapine Capsule
NDC Package 64850-892-01

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

Package Information

Loxapine capsules is loxapine is used to treat certain mental/mood disorders (such as schizophrenia). This formulation utilizes a capsule delivery system. Marketed by Elite Laboratories, Inc., this product is identified by NDC 64850-892 and is authorized under FDA application ANDA076868.

Identification & Billing

NDC Package Code
64850-892-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
64850-892
11-Digit Billing Format
64850089201
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
Loxapine
Non-Proprietary Name
Loxapine
Substance Name
Loxapine Succinate
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)
LOXAPINE SUCCINATE 25 mg/1
Usage Information
Loxapine is used to treat certain mental/mood disorders (such as schizophrenia). This medicine helps you to think more clearly, feel less nervous, and take part in everyday life. It can reduce aggression and the desire to hurt yourself/others. It may also help to decrease hallucinations (such as hearing/seeing things that are not there). Loxapine is a psychiatric medication (antipsychotic type) that works by helping to restore the balance of certain natural substances (such as dopamine) in the brain.

Regulatory & Marketing

Labeler Name
Elite Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076868
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-27-2020
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 64850-892-01 identifies a specific commercial package of 100 capsule in 1 bottle of Loxapine, a human prescription drug labeled by Elite Laboratories, Inc.. This capsule is formulated for oral use and contains loxapine succinate 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 Elite Laboratories, Inc. on January 27, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Loxapine is used to treat certain mental/mood disorders (such as schizophrenia). This medicine helps you to think more clearly, feel less nervous, and take part in everyday life. It can reduce aggression and the desire to hurt yourself/others. It may also help to decrease hallucinations (such as hearing/seeing things that are not there). Loxapine is a psychiatric medication (antipsychotic type) that works by helping to restore the balance of certain natural substances (such as dopamine) in the brain.

How is this Elite Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64850089201. 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)
64850-892-01
11-Digit CMS (5-4-2)
64850-0892-01

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