NDC 55289-213

Zyprexa

Olanzapine

Zyprexa is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Olanzapine.

Product ID55289-213_7bd524e6-2b5c-6377-e053-2a91aa0a2814
NDC55289-213
Product TypeHuman Prescription Drug
Proprietary NameZyprexa
Generic NameOlanzapine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1996-10-01
Marketing CategoryNDA / NDA
Application NumberNDA020592
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NameOLANZAPINE
Active Ingredient Strength10 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55289-213-30

30 TABLET in 1 BOTTLE, PLASTIC (55289-213-30)
Marketing Start Date2011-06-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-213-30 [55289021330]

Zyprexa TABLET
Marketing CategoryNDA
Application NumberNDA020592
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-21
Marketing End Date2019-09-11

Drug Details

Active Ingredients

IngredientStrength
OLANZAPINE10 mg/1

OpenFDA Data

SPL SET ID:7c6ff491-c30c-4ada-85a0-cbee98f2fe32
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 153048
  • 314154
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

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

    NDCBrand NameGeneric Name
    0002-4112ZyprexaOlanzapine
    0002-4115ZyprexaOlanzapine
    0002-4116ZyprexaOlanzapine
    0002-4117ZyprexaOlanzapine
    0002-4415ZyprexaOlanzapine
    0002-4420ZyprexaOlanzapine
    0002-4453ZYPREXAOlanzapine
    0002-4454ZYPREXAOlanzapine
    0002-4455ZYPREXAOlanzapine
    68258-7092ZyprexaZyprexa
    68258-7093ZyprexaZyprexa
    68258-7090ZyprexaZyprexa
    68258-7091ZyprexaZyprexa
    70518-1465ZyprexaZyprexa
    21695-144ZyprexaZyprexa
    21695-140ZyprexaZyprexa
    21695-142ZyprexaZyprexa
    49999-606ZyprexaZyprexa
    52959-579ZyprexaZyprexa
    55289-213ZyprexaZyprexa

    Trademark Results [Zyprexa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZYPREXA
    ZYPREXA
    75078626 2072867 Live/Registered
    Eli Lilly and Company
    1996-03-26

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