NDC 0002-4732

Olumiant

Baricitinib

Olumiant is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Baricitinib.

Product ID0002-4732_15ef688b-408f-4678-96b6-20068241d6db
NDC0002-4732
Product TypeHuman Prescription Drug
Proprietary NameOlumiant
Generic NameBaricitinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-10-08
Marketing CategoryNDA / NDA
Application NumberNDA207924
Labeler NameEli Lilly and Company
Substance NameBARICITINIB
Active Ingredient Strength1 mg/1
Pharm ClassesJanus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0002-4732-30

30 TABLET, FILM COATED in 1 BOTTLE (0002-4732-30)
Marketing Start Date2019-10-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0002-4732-30 [00002473230]

Olumiant TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA207924
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-08

Drug Details

Active Ingredients

IngredientStrength
BARICITINIB1 mg/1

OpenFDA Data

SPL SET ID:866e9f35-9035-4581-a4b1-75a621ab55cf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2047247
  • 2205472
  • 2205474
  • 2047241
  • UPC Code
  • 0300024732308
  • Pharmacological Class

    • Janus Kinase Inhibitor [EPC]
    • Janus Kinase Inhibitors [MoA]

    NDC Crossover Matching brand name "Olumiant" or generic name "Baricitinib"

    NDCBrand NameGeneric Name
    0002-4182Olumiantbaricitinib
    0002-4479Olumiantbaricitinib
    0002-4732Olumiantbaricitinib
    0002-6885Baricitinibbaricitinib

    Trademark Results [Olumiant]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OLUMIANT
    OLUMIANT
    86827321 not registered Dead/Abandoned
    Eli Lilly and Company
    2015-11-20
    OLUMIANT
    OLUMIANT
    86827315 5745831 Live/Registered
    Eli Lilly and Company
    2015-11-20
    OLUMIANT
    OLUMIANT
    86827301 not registered Dead/Abandoned
    Eli Lilly and Company
    2015-11-20
    OLUMIANT
    OLUMIANT
    86827297 not registered Dead/Abandoned
    Eli Lilly and Company
    2015-11-20
    OLUMIANT
    OLUMIANT
    86608577 not registered Dead/Abandoned
    Eli Lilly and Company
    2015-04-24
    OLUMIANT
    OLUMIANT
    85476697 4918353 Live/Registered
    Eli Lilly and Company
    2011-11-18

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