NDC 50419-488

Nexavar

Sorafenib

Nexavar is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Sorafenib.

Product ID50419-488_20ab7dba-4d59-4221-ad33-2dc86cd4f4e5
NDC50419-488
Product TypeHuman Prescription Drug
Proprietary NameNexavar
Generic NameSorafenib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2005-12-20
Marketing CategoryNDA / NDA
Application NumberNDA021923
Labeler NameBayer HealthCare Pharmaceuticals Inc.
Substance NameSORAFENIB
Active Ingredient Strength200 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50419-488-58

120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-488-58)
Marketing Start Date2005-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50419-488-58 [50419048858]

Nexavar TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021923
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-12-20

Drug Details

Active Ingredients

IngredientStrength
SORAFENIB200 mg/1

OpenFDA Data

SPL SET ID:b50667e4-5ebc-4968-a646-d605058dbef0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 597747
  • 615979
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Nexavar" or generic name "Sorafenib"

    NDCBrand NameGeneric Name
    50419-488Nexavarsorafenib
    0480-5425SorafenibSorafenib
    24979-715SorafenibSorafenib
    43598-458sorafenibsorafenib
    51990-201SorafenibSorafenib
    0378-1201Sorafenib TosylateSorafenib

    Trademark Results [Nexavar]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NEXAVAR
    NEXAVAR
    78670152 3537095 Live/Registered
    Bayer Aktiengesellschaft
    2005-07-14
    NEXAVAR
    NEXAVAR
    75943985 2745627 Live/Registered
    Bayer Aktiengesellschaft
    2000-03-14

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