NDC 50419-171

Stivarga

Regorafenib

Stivarga 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 Regorafenib Monohydrate.

Product ID50419-171_39f424e8-6b78-4a30-b19f-de42dc208856
NDC50419-171
Product TypeHuman Prescription Drug
Proprietary NameStivarga
Generic NameRegorafenib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-09-27
Marketing CategoryNDA / NDA
Application NumberNDA203085
Labeler NameBayer HealthCare Pharmaceuticals Inc.
Substance NameREGORAFENIB MONOHYDRATE
Active Ingredient Strength40 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50419-171-00

210 BOTTLE in 1 BOX (50419-171-00) > 28 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2012-09-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50419-171-01 [50419017101]

Stivarga TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA203085
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-27

NDC 50419-171-03 [50419017103]

Stivarga TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA203085
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-27

NDC 50419-171-00 [50419017100]

Stivarga TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA203085
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-27

NDC 50419-171-04 [50419017104]

Stivarga TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA203085
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-27

Drug Details

Active Ingredients

IngredientStrength
REGORAFENIB MONOHYDRATE40 mg/1

OpenFDA Data

SPL SET ID:824f19c9-0546-4a8a-8d8f-c4055c04f7c7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1312408
  • 1312402
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Protein Kinase Inhibitors [MoA]
    • Cytochrome P450 2C9 Inhibitors [MoA]

    Trademark Results [Stivarga]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    STIVARGA
    STIVARGA
    85392954 4111942 Live/Registered
    Bayer Aktiengesellschaft
    2011-08-09

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