NDC 0078-0393

Simulect

Basiliximab

Simulect is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Basiliximab.

Product ID0078-0393_0673b70a-a94f-4a8b-8153-1402e33fa3e0
NDC0078-0393
Product TypeHuman Prescription Drug
Proprietary NameSimulect
Generic NameBasiliximab
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1998-05-12
Marketing CategoryBLA / BLA
Application NumberBLA103764
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameBASILIXIMAB
Active Ingredient Strength10 mg/2.5mL
Pharm ClassesInterleukin 2 Receptor Antagonists [MoA],Interleukin 2 Receptor-directed Antibody Interactions [MoA],Interleukin-2 Receptor Blocking Antibody [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0078-0393-61

1 VIAL, SINGLE-USE in 1 CARTON (0078-0393-61) > 2.5 mL in 1 VIAL, SINGLE-USE
Marketing Start Date1998-05-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0393-61 [00078039361]

Simulect INJECTION, POWDER, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA103764
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-05-12

Drug Details

Active Ingredients

IngredientStrength
BASILIXIMAB10 mg/2.5mL

OpenFDA Data

SPL SET ID:1af01887-b69d-444b-91ed-ebfe12784440
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1656650
  • 1656646
  • 1656648
  • 1656643
  • Pharmacological Class

    • Interleukin 2 Receptor Antagonists [MoA]
    • Interleukin 2 Receptor-directed Antibody Interactions [MoA]
    • Interleukin-2 Receptor Blocking Antibody [EPC]

    NDC Crossover Matching brand name "Simulect" or generic name "Basiliximab"

    NDCBrand NameGeneric Name
    0078-0331Simulectbasiliximab
    0078-0393Simulectbasiliximab

    Trademark Results [Simulect]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SIMULECT
    SIMULECT
    79059709 3639864 Live/Registered
    Novartis AG
    2008-09-24
    SIMULECT
    SIMULECT
    74665427 2122043 Live/Registered
    NOVARTIS AG
    1995-04-24
    SIMULECT
    SIMULECT
    74342122 not registered Dead/Abandoned
    SANDOZ AG (SANDOZ LTD., SANDOZ S.A.)
    1992-12-18

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