NDC 0310-7820

CAPRELSA

Vandetanib

CAPRELSA is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Vandetanib.

Product ID0310-7820_e7eebdc7-a867-4d35-9b5b-2c1829a4e778
NDC0310-7820
Product TypeHuman Prescription Drug
Proprietary NameCAPRELSA
Generic NameVandetanib
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-07-25
Marketing End Date2020-05-31
Marketing CategoryNDA / NDA
Application NumberNDA022405
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameVANDETANIB
Active Ingredient Strength100 mg/1
Pharm ClassesKinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 0310-7820-30

30 TABLET in 1 BOTTLE, PLASTIC (0310-7820-30)
Marketing Start Date2011-07-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-7820-30 [00310782030]

CAPRELSA TABLET
Marketing CategoryNDA
Application NumberNDA022405
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-25
Marketing End Date2020-05-31

Drug Details

Active Ingredients

IngredientStrength
VANDETANIB100 mg/1

OpenFDA Data

SPL SET ID:4dc7f0af-77fb-4eec-46b9-dd1c2dcb4525
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1098418
  • 1114074
  • 1098416
  • 1114096
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Protein Kinase Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]
    • Organic Cation Transporter 2 Inhibitors [MoA]
    • Kinase Inhibitor [EPC]
    • Protein Kinase Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]
    • Organic Cation Transporter 2 Inhibitors [MoA]

    NDC Crossover Matching brand name "CAPRELSA" or generic name "Vandetanib"

    NDCBrand NameGeneric Name
    0310-7820CAPRELSAVandetanib
    0310-7840CAPRELSAVandetanib
    58468-7820CAPRELSAVandetanib
    58468-7840CAPRELSAVandetanib
    58468-7860CAPRELSAVandetanib

    Trademark Results [CAPRELSA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CAPRELSA
    CAPRELSA
    85360880 4211262 Live/Registered
    GENZYME CORPORATION
    2011-06-30
    CAPRELSA
    CAPRELSA
    78588611 3092679 Live/Registered
    GENZYME CORPORATION
    2005-03-16

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