Loxapine
NDC Package 10135-587-01

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Loxapine is used to treat certain mental/mood disorders (such as schizophrenia). Marketed by Marlex Pharmaceuticals Inc, this product is identified by NDC 10135-587 and is authorized under FDA application ANDA090695.

Identification & Billing

NDC Package Code
10135-587-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
10135-587
11-Digit Billing Format
10135058701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Loxapine
Dosage Form
-
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
Marlex Pharmaceuticals Inc
FDA Application #
ANDA090695
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2014
Listing Expiration
12-31-2018
Exclude Flag
I
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 (10135-587). Click a package code to view its specific billing and regulatory data.

10135-587-10
1000 TABLET 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 10135-587-01 identifies a specific commercial package of 100 tablet in 1 bottle of Loxapine, 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 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 Marlex Pharmaceuticals Inc on October 01, 2014. The current certification is valid through December 31, 2018.

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 Marlex Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135058701. 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)
10135-587-01
11-Digit CMS (5-4-2)
10135-0587-01

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