NDC 69809-0126
Clozaril
Clozapine
Clozaril is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Hls Therapeutics (usa), Inc.. The primary component is Clozapine.
| Product ID | 69809-0126_29feed9f-c971-4c63-bcfc-0776c12215cf |
| NDC | 69809-0126 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Clozaril |
| Generic Name | Clozapine |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-05-06 |
| Marketing Category | NDA / NDA |
| Application Number | NDA019758 |
| Labeler Name | HLS Therapeutics (USA), Inc. |
| Substance Name | CLOZAPINE |
| Active Ingredient Strength | 25 mg/1 |
| Pharm Classes | Atypical Antipsychotic [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 69809-0126-5
100 TABLET in 1 BOTTLE (69809-0126-5)
| Marketing Start Date | 2016-05-06 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 69809-0126-5 [69809012605]
Clozaril TABLET
| Marketing Category | NDA |
| Application Number | NDA019758 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-05-06 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| CLOZAPINE | 25 mg/1 |
OpenFDA Data
| SPL SET ID: | 90876802-0e3a-44c9-9ff7-1754dfbe736a |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- Atypical Antipsychotic [EPC]
NDC Crossover Matching brand name "Clozaril" or generic name "Clozapine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 69809-0126 | Clozaril | Clozaril |
| 69809-0127 | Clozaril | Clozaril |
| 64725-1260 | Clozaril | Clozaril |
| 69809-0130 | Clozaril | Clozaril |
| 69809-0135 | Clozaril | Clozaril |
| 0093-3010 | Clozapine | clozapine |
| 0093-3011 | Clozapine | clozapine |
| 0093-3012 | Clozapine | clozapine |
| 0093-3086 | Clozapine | clozapine |
| 0093-3087 | Clozapine | clozapine |
| 0093-4359 | Clozapine | Clozapine |
| 0093-4404 | Clozapine | Clozapine |
| 0093-4405 | Clozapine | Clozapine |
| 0093-5376 | Clozapine | Clozapine |
| 0093-5377 | Clozapine | Clozapine |
Trademark Results [Clozaril]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLOZARIL 86255900 4998741 Live/Registered |
Novartis AG 2014-04-18 |
 CLOZARIL 74230944 1833795 Dead/Cancelled |
NOVARTIS AG 1991-12-16 |
 CLOZARIL 73394129 1265560 Live/Registered |
Sandoz, Inc. 1982-09-29 |
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