NDC 0078-0734

Ilaris

Canakinumab

Ilaris is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Canakinumab.

Product ID0078-0734_110863fe-9a07-49e2-85ea-f0442fc0eb41
NDC0078-0734
Product TypeHuman Prescription Drug
Proprietary NameIlaris
Generic NameCanakinumab
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2016-12-22
Marketing CategoryBLA / BLA
Application NumberBLA125319
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameCANAKINUMAB
Active Ingredient Strength150 mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0078-0734-61

1 VIAL, SINGLE-USE in 1 CARTON (0078-0734-61) > 1 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2016-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0734-61 [00078073461]

Ilaris INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125319
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-12-22

Drug Details

Active Ingredients

IngredientStrength
CANAKINUMAB150 mg/mL

OpenFDA Data

SPL SET ID:7d271f3b-e4f9-4d80-8dcf-28d49123f80e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 853494
  • 1864326
  • 853498
  • 1864324
  • NDC Crossover Matching brand name "Ilaris" or generic name "Canakinumab"

    NDCBrand NameGeneric Name
    0078-0582Ilariscanakinumab
    0078-0734Ilariscanakinumab

    Trademark Results [Ilaris]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ILARIS
    ILARIS
    79018797 3181206 Live/Registered
    Novartis AG
    2005-10-19
    ILARIS
    ILARIS
    78004890 2446597 Dead/Cancelled
    Novartis AG
    2000-04-20
    ILARIS
    ILARIS
    77708333 3797205 Live/Registered
    Novartis AG
    2009-04-07
    ILARIS
    ILARIS
    77626337 not registered Dead/Abandoned
    Novartis AG
    2008-12-04
    ILARIS
    ILARIS
    75638247 2349785 Dead/Cancelled
    Novartis AG
    1999-02-16

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