| Product NDC: | 18860-104 | 
| Proprietary Name: | FazaClo | 
| Non Proprietary Name: | clozapine | 
| Active Ingredient(s): | 100 mg/1 & nbsp; clozapine | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET, ORALLY DISINTEGRATING | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 18860-104 | 
| Labeler Name: | Jazz Pharmaceuticals, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA021590 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20080601 | 
| Package NDC: | 18860-104-10 | 
| Package Description: | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (18860-104-10) | 
| NDC Code | 18860-104-10 | 
| Proprietary Name | FazaClo | 
| Package Description | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (18860-104-10) | 
| Product NDC | 18860-104 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | clozapine | 
| Dosage Form Name | TABLET, ORALLY DISINTEGRATING | 
| Route Name | ORAL | 
| Start Marketing Date | 20080601 | 
| Marketing Category Name | NDA | 
| Labeler Name | Jazz Pharmaceuticals, Inc. | 
| Substance Name | CLOZAPINE | 
| Strength Number | 100 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Atypical Antipsychotic [EPC] |