Fazaclo
NDC Package 18860-102-01

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 discontinued by the firm.

Fazaclo is see also Warning section. Marketed by Jazz Pharmaceuticals, Inc., this product is identified by NDC 18860-102 and is authorized under FDA application NDA021590.

Identification & Billing

NDC Package Code
18860-102-01
Package Description
8 BLISTER PACK in 1 CARTON / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code
18860-102
11-Digit Billing Format
18860010201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
8 EA

Clinical Specifications

Proprietary Name
Fazaclo
Dosage Form
-
Usage Information
See also Warning section. This medication is used to treat certain mental/mood disorders (schizophrenia, schizoaffective disorders). Clozapine is a psychiatric medication (anti-psychotic type) that works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. Clozapine decreases hallucinations and helps prevent suicide in people who are likely to try to harm themselves. It helps you to think more clearly and positively about yourself, feel less nervous, and take part in everyday life.

Regulatory & Marketing

Labeler Name
Jazz Pharmaceuticals, Inc.
FDA Application #
NDA021590
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-01-2008
End Marketing Date
03-31-2020
Listing Expiration
03-31-2020
Exclude Flag
D
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 (18860-102). Click a package code to view its specific billing and regulatory data.

18860-102-10
100 TABLET, ORALLY DISINTEGRATING 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 18860-102-01 identifies a specific commercial package of 8 blister pack in 1 carton / 6 tablet, orally disintegrating in 1 blister pack of Fazaclo, labeled by Jazz Pharmaceuticals, Inc.. 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 Jazz Pharmaceuticals, Inc. on June 01, 2008. The current certification is valid through March 31, 2020.

What are the primary indications for this medication?

See also Warning section. This medication is used to treat certain mental/mood disorders (schizophrenia, schizoaffective disorders). Clozapine is a psychiatric medication (anti-psychotic type) that works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. Clozapine decreases hallucinations and helps prevent suicide in people who are likely to try to harm themselves. It helps you to think more clearly and positively about yourself, feel less nervous, and take part in everyday life.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 18860010201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 8 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)
18860-102-01
11-Digit CMS (5-4-2)
18860-0102-01

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