NDC 68382-365

olanzapine

Olanzapine

olanzapine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals Usa Inc.. The primary component is Olanzapine.

Product ID68382-365_07ce1a1f-b10a-4dfc-a96e-15d1d7db3678
NDC68382-365
Product TypeHuman Prescription Drug
Proprietary Nameolanzapine
Generic NameOlanzapine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-01-03
Marketing CategoryANDA / ANDA
Application NumberANDA090459
Labeler NameZydus Pharmaceuticals USA Inc.
Substance NameOLANZAPINE
Active Ingredient Strength5 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68382-365-01

100 TABLET, FILM COATED in 1 BOTTLE (68382-365-01)
Marketing Start Date2019-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-365-01 [68382036501]

olanzapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090459
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-03

NDC 68382-365-30 [68382036530]

olanzapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090459
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-03

NDC 68382-365-14 [68382036514]

olanzapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090459
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-03

NDC 68382-365-10 [68382036510]

olanzapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090459
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-03

NDC 68382-365-06 [68382036506]

olanzapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090459
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-03

NDC 68382-365-77 [68382036577]

olanzapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090459
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-03

Drug Details

Active Ingredients

IngredientStrength
OLANZAPINE5 mg/1

OpenFDA Data

SPL SET ID:3bdb98d1-1c19-4439-93da-c7f4e96063aa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200034
  • 312077
  • 312079
  • 312078
  • 314154
  • 283639
    • UPC Code
  • 0368382365101
  • 0368382368102

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "olanzapine" or generic name "Olanzapine"

    NDCBrand NameGeneric Name
    67877-175OlanzapineOlanzapine
    67877-174OlanzapineOlanzapine
    67877-172OlanzapineOlanzapine
    67877-173OlanzapineOlanzapine
    67877-176OlanzapineOlanzapine
    67877-177OlanzapineOlanzapine
    68084-529OlanzapineOlanzapine
    68084-723OlanzapineOlanzapine
    68084-528OlanzapineOlanzapine
    68084-740OlanzapineOlanzapine
    68084-525OlanzapineOlanzapine
    68258-7095OlanzapineOlanzapine
    68258-7152OlanzapineOlanzapine
    68258-7153OlanzapineOlanzapine
    68258-7154OlanzapineOlanzapine
    68382-365olanzapineolanzapine
    68382-368olanzapineolanzapine
    68258-7096OlanzapineOlanzapine
    68382-367olanzapineolanzapine
    68382-364olanzapineolanzapine
    68382-366olanzapineolanzapine
    68382-369olanzapineolanzapine
    68788-7161OlanzapineOlanzapine
    0517-0955OlanzapineOlanzapine
    69189-5510OlanzapineOlanzapine
    69543-384OlanzapineOlanzapine
    69543-380OlanzapineOlanzapine
    69543-381OlanzapineOlanzapine
    69543-383OlanzapineOlanzapine
    69543-382OlanzapineOlanzapine
    69543-385OlanzapineOlanzapine
    69807-2012OlanzapineOlanzapine
    69807-2011OlanzapineOlanzapine
    69807-2013OlanzapineOlanzapine
    70518-0026OlanzapineOlanzapine
    70518-0148OlanzapineOlanzapine
    70518-0145OlanzapineOlanzapine
    70518-0149OlanzapineOlanzapine
    70518-0314OlanzapineOlanzapine
    70518-0477OlanzapineOlanzapine
    70518-0110OlanzapineOlanzapine
    70518-0616OlanzapineOlanzapine
    70518-0144OlanzapineOlanzapine
    70518-0433OlanzapineOlanzapine
    70518-1206OlanzapineOlanzapine
    70518-0921OlanzapineOlanzapine
    70518-1207OlanzapineOlanzapine
    70518-0615OlanzapineOlanzapine
    70518-1115OlanzapineOlanzapine
    70518-1154OlanzapineOlanzapine
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