NDC 0069-0550

SUTENT

Sunitinib Malate

SUTENT is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Sunitinib Malate.

Product ID0069-0550_0631931c-59a1-4b76-a79c-24f5d0f27493
NDC0069-0550
Product TypeHuman Prescription Drug
Proprietary NameSUTENT
Generic NameSunitinib Malate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2006-01-26
Marketing CategoryNDA / NDA
Application NumberNDA021938
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameSUNITINIB MALATE
Active Ingredient Strength13 mg/1
Pharm ClassesProtein Kinase Inhibitors [MoA],Kinase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0069-0550-38

28 CAPSULE in 1 BOTTLE (0069-0550-38)
Marketing Start Date2006-01-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-0550-38 [00069055038]

SUTENT CAPSULE
Marketing CategoryNDA
Application NumberNDA021938
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-01-26

Drug Details

Active Ingredients

IngredientStrength
SUNITINIB MALATE12.5 mg/1

OpenFDA Data

SPL SET ID:43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616279
  • 1541890
  • 616289
  • 616292
  • 1541928
  • 616283
  • 616285
  • 616287
    • UPC Code
  • 0300690550381
  • 0300690770383
  • 0300690830384
  • 0300690980386

    • Pharmacological Class

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

    NDC Crossover Matching brand name "SUTENT" or generic name "Sunitinib Malate"

    NDCBrand NameGeneric Name
    0069-0550SUTENTSunitinib malate
    0069-0770SUTENTSunitinib malate
    0069-0830SUTENTSunitinib malate
    0069-0980SUTENTSunitinib malate
    63539-017SUTENTSUTENT
    63539-019SUTENTSUTENT
    0093-8199Sunitinib MalateSunitinib Malate
    0093-8224Sunitinib MalateSunitinib Malate
    0093-8229Sunitinib MalateSunitinib Malate
    0093-8231Sunitinib MalateSunitinib Malate
    0378-6678Sunitinib Malatesunitinib malate
    0378-6679Sunitinib Malatesunitinib malate
    0378-6680Sunitinib Malatesunitinib malate
    0378-6681Sunitinib Malatesunitinib malate
    16714-676Sunitinib malateSunitinib malate
    16714-677Sunitinib malateSunitinib malate

    Trademark Results [SUTENT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SUTENT
    SUTENT
    78750554 3170173 Live/Registered
    C.P. PHARMACEUTICALS INTERNATIONAL C.V.
    2005-11-09
    SUTENT
    SUTENT
    78639799 not registered Dead/Abandoned
    Pharmacia & Upjohn Company LLC
    2005-05-31
    SUTENT
    SUTENT
    76388649 2948764 Live/Registered
    C.P. PHARMACEUTICALS INTERNATIONAL C.V.
    2002-03-26
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