Clozapine
NDC Package 0093-3012-84
Package Information
Clozapine is see also Warning section. Marketed by Teva Pharmaceuticals Usa Inc, this product is identified by NDC 0093-3012 and is authorized under FDA application NDA021590.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0093 - Teva Pharmaceuticals Usa Inc
- 0093-3012 - Clozapine
- 0093-3012-84 - 48 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-3012-19)
- 0093-3012 - Clozapine
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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Other Available Packages
The following commercial packages are registered under the same Product NDC (0093-3012). Click a package code to view its specific billing and regulatory data.
* 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 0093-3012-84 identifies a specific commercial package of 48 blister pack in 1 carton / 1 tablet, orally disintegrating in 1 blister pack (0093-3012-19) of Clozapine, labeled by Teva Pharmaceuticals Usa Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 48 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 Teva Pharmaceuticals Usa Inc on August 30, 2012. The current certification is valid through November 30, 2019.
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 Teva Pharmaceuticals Usa Inc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00093301284. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 48 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 Labeler segment to maintain the 5-4-2 structure.