NDC 64725-1260

Clozaril

Clozapine

Clozaril is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Tya Pharmaceuticals. The primary component is Clozapine.

Product ID64725-1260_089b76b6-71af-4893-bb1b-4890fcc4a3e5
NDC64725-1260
Product TypeHuman Prescription Drug
Proprietary NameClozaril
Generic NameClozapine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1989-09-30
Marketing CategoryNDA / NDA
Application NumberNDA019758
Labeler NameTYA Pharmaceuticals
Substance NameCLOZAPINE
Active Ingredient Strength25 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 64725-1260-1

30 TABLET in 1 CONTAINER (64725-1260-1)
Marketing Start Date1989-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64725-1260-1 [64725126001]

Clozaril TABLET
Marketing CategoryNDA
Application NumberNDA019758
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1989-09-30
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
CLOZAPINE25 mg/1

OpenFDA Data

SPL SET ID:0cf63b13-48b2-4b07-b241-617725b52f6b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197536
  • 104775
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "Clozaril" or generic name "Clozapine"

    NDCBrand NameGeneric Name
    69809-0126ClozarilClozaril
    69809-0127ClozarilClozaril
    64725-1260ClozarilClozaril
    69809-0130ClozarilClozaril
    69809-0135ClozarilClozaril
    0093-3010Clozapineclozapine
    0093-3011Clozapineclozapine
    0093-3012Clozapineclozapine
    0093-3086Clozapineclozapine
    0093-3087Clozapineclozapine
    0093-4359ClozapineClozapine
    0093-4404ClozapineClozapine
    0093-4405ClozapineClozapine
    0093-5376ClozapineClozapine
    0093-5377ClozapineClozapine

    Trademark Results [Clozaril]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CLOZARIL
    CLOZARIL
    86255900 4998741 Live/Registered
    Novartis AG
    2014-04-18
    CLOZARIL
    CLOZARIL
    74230944 1833795 Dead/Cancelled
    NOVARTIS AG
    1991-12-16
    CLOZARIL
    CLOZARIL
    73394129 1265560 Live/Registered
    Sandoz, Inc.
    1982-09-29

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.