NDC 69809-0135

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 ID69809-0135_29feed9f-c971-4c63-bcfc-0776c12215cf
NDC69809-0135
Product TypeHuman Prescription Drug
Proprietary NameClozaril
Generic NameClozapine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-12-17
Marketing CategoryNDA / NDA
Application NumberNDA019758
Labeler NameHLS Therapeutics (USA), Inc.
Substance NameCLOZAPINE
Active Ingredient Strength200 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 69809-0135-5

100 TABLET in 1 BOTTLE (69809-0135-5)
Marketing Start Date2019-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69809-0135-5 [69809013505]

Clozaril TABLET
Marketing CategoryNDA
Application NumberNDA019758
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-12-17

Drug Details

Active Ingredients

IngredientStrength
CLOZAPINE200 mg/1

OpenFDA Data

SPL SET ID:90876802-0e3a-44c9-9ff7-1754dfbe736a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2269081
  • 429212
  • 2269079
  • 309374
  • 104776
  • 104775
  • 197535
  • 197536
    • UPC Code
  • 0369809012752
  • 0369809013551
  • 0369809013056
  • 0369809012653

    • 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
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