Fazaclo
NDC Package 18860-101-10
Package Information
Fazaclo is see also Warning section. Marketed by Jazz Pharmaceuticals, Inc., this product is identified by NDC 18860-101 and is authorized under FDA application NDA021590.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 18860 - Jazz Pharmaceuticals, Inc.
- 18860-101 - Fazaclo
- 18860-101-10 - 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
- 18860-101 - Fazaclo
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 18860-101-10 identifies a specific commercial package of 100 tablet, orally disintegrating in 1 bottle of Fazaclo, labeled by Jazz 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 Jazz Pharmaceuticals, Inc. on July 01, 2007. The current certification is valid through February 28, 2021.
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: 18860010110. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.