NDC 0093-5417

Clozapine

Clozapine

Clozapine is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Clozapine.

Product ID0093-5417_0c53e758-c02f-4b2a-a57d-60766050f8cb
NDC0093-5417
Product TypeHuman Prescription Drug
Proprietary NameClozapine
Generic NameClozapine
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2017-07-25
Marketing CategoryANDA / ANDA
Application NumberANDA090308
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameCLOZAPINE
Active Ingredient Strength25 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0093-5417-01

100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5417-01)
Marketing Start Date2017-07-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-5417-19 [00093541719]

Clozapine TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA090308
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-25

NDC 0093-5417-84 [00093541784]

Clozapine TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA090308
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-25

NDC 0093-5417-01 [00093541701]

Clozapine TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA090308
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-25

Drug Details

Active Ingredients

IngredientStrength
CLOZAPINE25 mg/1

OpenFDA Data

SPL SET ID:6fccf4f7-2e30-4272-9800-225aaef20584
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 476177
  • 476179
  • 721773
    • UPC Code
  • 0300935416014

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]

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

    NDCBrand NameGeneric Name
    0093-3010Clozapineclozapine
    0093-3011Clozapineclozapine
    0093-3012Clozapineclozapine
    0093-3086Clozapineclozapine
    0093-3087Clozapineclozapine
    0093-4359ClozapineClozapine
    0093-4404ClozapineClozapine
    0093-4405ClozapineClozapine
    0093-5376ClozapineClozapine
    0093-5377ClozapineClozapine
    0781-5989ClozapineClozapine
    0781-5992ClozapineClozapine
    0093-5417ClozapineClozapine
    0093-5419ClozapineClozapine
    0093-5416ClozapineClozapine
    16729-142ClozapineClozapine
    16729-141ClozapineClozapine
    0093-7772ClozapineClozapine
    51079-922ClozapineClozapine
    51079-212ClozapineClozapine
    51079-288ClozapineClozapine
    51079-749ClozapineClozapine
    51079-921ClozapineClozapine
    51862-271ClozapineClozapine
    51862-273ClozapineClozapine
    51862-274ClozapineClozapine
    51862-272ClozapineClozapine
    55154-8285ClozapineClozapine
    57664-211CLOZAPINECLOZAPINE
    57664-241CLOZAPINECLOZAPINE
    57664-345CLOZAPINECLOZAPINE
    57664-347CLOZAPINECLOZAPINE
    60429-989ClozapineClozapine
    60429-990ClozapineClozapine
    60687-404CLOZAPINECLOZAPINE
    60687-415CLOZAPINECLOZAPINE
    60687-426CLOZAPINECLOZAPINE
    0378-0825ClozapineClozapine
    0378-0860ClozapineClozapine
    0378-0973ClozapineClozapine
    0378-0972ClozapineClozapine
    0378-3813ClozapineClozapine
    0378-3815ClozapineClozapine
    65862-846CLOZAPINECLOZAPINE
    65862-845CLOZAPINECLOZAPINE
    65862-847CLOZAPINECLOZAPINE
    65862-844CLOZAPINECLOZAPINE
    72721-1760ClozapineClozapine
    72721-1725ClozapineClozapine
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