NDC 0078-0592

Tasigna

Nilotinib

Tasigna is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Nilotinib.

Product ID0078-0592_404b85a1-6329-432c-a18f-a9588c009551
NDC0078-0592
Product TypeHuman Prescription Drug
Proprietary NameTasigna
Generic NameNilotinib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2007-10-29
Marketing CategoryNDA / NDA
Application NumberNDA022068
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameNILOTINIB
Active Ingredient Strength150 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0078-0592-51

28 CAPSULE in 1 BLISTER PACK (0078-0592-51)
Marketing Start Date2007-10-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0592-51 [00078059251]

Tasigna CAPSULE
Marketing CategoryNDA
Application NumberNDA022068
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-10-29

NDC 0078-0592-87 [00078059287]

Tasigna CAPSULE
Marketing CategoryNDA
Application NumberNDA022068
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-10-29

Drug Details

Active Ingredients

IngredientStrength
NILOTINIB150 mg/1

OpenFDA Data

SPL SET ID:6093952a-5248-45cb-ad17-33716a411146
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2002717
  • 746606
  • 997653
  • 2002719
  • 746609
  • 1002300
  • UPC Code
  • 0300780951661
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Tasigna" or generic name "Nilotinib"

    NDCBrand NameGeneric Name
    0078-0526Tasignanilotinib
    0078-0592Tasignanilotinib
    0078-0951Tasignanilotinib

    Trademark Results [Tasigna]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TASIGNA
    TASIGNA
    79062925 3635627 Live/Registered
    Novartis AG
    2008-08-07
    TASIGNA
    TASIGNA
    78458843 2995313 Dead/Cancelled
    Novartis AG
    2004-07-29

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