NDC 52343-042

OLANZAPINE

Olanzapine

OLANZAPINE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Acetris Health, Llc. The primary component is Olanzapine.

Product ID52343-042_4354fe74-d83c-4a15-b3de-2b04c8950eeb
NDC52343-042
Product TypeHuman Prescription Drug
Proprietary NameOLANZAPINE
Generic NameOlanzapine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-09-26
Marketing CategoryANDA / ANDA
Application NumberANDA202050
Labeler NameACETRIS HEALTH, LLC
Substance NameOLANZAPINE
Active Ingredient Strength15 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52343-042-30

30 TABLET in 1 BOTTLE (52343-042-30)
Marketing Start Date2014-09-26
Marketing End Date2021-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52343-042-99 [52343004299]

OLANZAPINE TABLET
Marketing CategoryANDA
Application NumberANDA202050
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-26
Marketing End Date2021-05-01

NDC 52343-042-30 [52343004230]

OLANZAPINE TABLET
Marketing CategoryANDA
Application NumberANDA202050
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-26
Marketing End Date2021-05-01

Drug Details

Active Ingredients

IngredientStrength
OLANZAPINE15 mg/1

OpenFDA Data

SPL SET ID:13591d0b-0d4a-4bb4-bf49-d54ba5ca1759
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200034
  • 312077
  • 312079
  • 312078
  • 314154
  • 283639
  • UPC Code
  • 0352343040305
  • 0352343042309
  • 0352343039309
  • 0352343038302
  • 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.