NDC 64725-0955

Olanzapine

Olanzapine

Olanzapine is a Intramuscular Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Tya Pharmaceuticals. The primary component is Olanzapine.

Product ID64725-0955_e66eb52e-210e-49f2-910d-38ac51616e63
NDC64725-0955
Product TypeHuman Prescription Drug
Proprietary NameOlanzapine
Generic NameOlanzapine
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2012-06-27
Marketing CategoryANDA / ANDA
Application NumberANDA201741
Labeler NameTYA Pharmaceuticals
Substance NameOLANZAPINE
Active Ingredient Strength10 mg/2mL
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 64725-0955-1

1 mL in 1 CARTON (64725-0955-1)
Marketing Start Date2012-06-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64725-0955-1 [64725095501]

Olanzapine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA201741
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-06-27
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OLANZAPINE10 mg/2mL

OpenFDA Data

SPL SET ID:591f9bb1-f119-4739-87b0-de29c9446727
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485968
  • 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.