NDC 65862-844

CLOZAPINE

Clozapine

CLOZAPINE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Clozapine.

Product ID65862-844_58ed79c1-76e2-4fa5-942f-edf87395f857
NDC65862-844
Product TypeHuman Prescription Drug
Proprietary NameCLOZAPINE
Generic NameClozapine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-11-29
Marketing CategoryANDA / ANDA
Application NumberANDA206433
Labeler NameAurobindo Pharma Limited
Substance NameCLOZAPINE
Active Ingredient Strength25 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 65862-844-01

100 TABLET in 1 BOTTLE (65862-844-01)
Marketing Start Date2016-11-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-844-05 [65862084405]

CLOZAPINE TABLET
Marketing CategoryANDA
Application NumberANDA206433
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-29

NDC 65862-844-78 [65862084478]

CLOZAPINE TABLET
Marketing CategoryANDA
Application NumberANDA206433
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-29

NDC 65862-844-10 [65862084410]

CLOZAPINE TABLET
Marketing CategoryANDA
Application NumberANDA206433
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-29

NDC 65862-844-01 [65862084401]

CLOZAPINE TABLET
Marketing CategoryANDA
Application NumberANDA206433
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-29

Drug Details

Active Ingredients

IngredientStrength
CLOZAPINE25 mg/1

OpenFDA Data

SPL SET ID:5021d643-32d2-4167-b5d8-90870e68a787
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197535
  • 309374
  • 197536
  • 429212
  • UPC Code
  • 0365862847782
  • 0365862845016
  • 0365862844019
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    Medicade Reported Pricing

    65862084401 CLOZAPINE 25 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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