NDC 70518-0145

Olanzapine

Olanzapine

Olanzapine is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Olanzapine.

Product ID70518-0145_812b71ea-488d-7e5e-e053-2a91aa0a7e57
NDC70518-0145
Product TypeHuman Prescription Drug
Proprietary NameOlanzapine
Generic NameOlanzapine
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2017-01-19
Marketing CategoryANDA / ANDA
Application NumberANDA203044
Labeler NameREMEDYREPACK INC.
Substance NameOLANZAPINE
Active Ingredient Strength10 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0145-0

30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (70518-0145-0)
Marketing Start Date2017-01-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0145-0 [70518014500]

Olanzapine TABLET, ORALLY DISINTEGRATING
Marketing CategoryANDA
Application NumberANDA203044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-19
Marketing End Date2019-02-04

Drug Details

Active Ingredients

IngredientStrength
OLANZAPINE10 mg/1

OpenFDA Data

SPL SET ID:72aa6640-f4a6-47ce-b146-38242a8bfd79
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312076
  • 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.