NDC 0904-6286

Olanzapine

Olanzapine

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

Product ID0904-6286_4530c210-e39b-41e9-b751-7edb9dd4eb8a
NDC0904-6286
Product TypeHuman Prescription Drug
Proprietary NameOlanzapine
Generic NameOlanzapine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-04-23
Marketing CategoryANDA / ANDA
Application NumberANDA076133
Labeler NameMajor Pharmaceuticals
Substance NameOLANZAPINE
Active Ingredient Strength15 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0904-6286-06

50 BLISTER PACK in 1 CARTON (0904-6286-06) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2012-04-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6286-79 [00904628679]

Olanzapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076133
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-23
Marketing End Date2012-08-07

NDC 0904-6286-30 [00904628630]

Olanzapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076133
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-23
Marketing End Date2012-08-07

NDC 0904-6286-05 [00904628605]

Olanzapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076133
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-23
Marketing End Date2012-08-07

NDC 0904-6286-61 [00904628661]

Olanzapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076133
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-23

NDC 0904-6286-01 [00904628601]

Olanzapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076133
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-23
Marketing End Date2012-08-07

NDC 0904-6286-78 [00904628678]

Olanzapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076133
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-23
Marketing End Date2012-08-07

NDC 0904-6286-06 [00904628606]

Olanzapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076133
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-23

Drug Details

Active Ingredients

IngredientStrength
OLANZAPINE15 mg/1

OpenFDA Data

SPL SET ID:709d79a1-2742-4629-af43-161be166833a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283639
  • 312077

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