NDC 58468-7840

CAPRELSA

Vandetanib

CAPRELSA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Vandetanib.

Product ID58468-7840_1b138df2-ee22-47e9-aa69-06445ff56eed
NDC58468-7840
Product TypeHuman Prescription Drug
Proprietary NameCAPRELSA
Generic NameVandetanib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-07-25
Marketing CategoryNDA / NDA
Application NumberNDA022405
Labeler NameGenzyme Corporation
Substance NameVANDETANIB
Active Ingredient Strength300 mg/1
Pharm ClassesKinase Inhibitor [EPC], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 58468-7840-3

1 BOTTLE, PLASTIC in 1 CARTON (58468-7840-3) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Start Date2011-07-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58468-7840-3 [58468784003]

CAPRELSA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022405
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-25

Drug Details

Active Ingredients

IngredientStrength
VANDETANIB300 mg/1

OpenFDA Data

SPL SET ID:e5721cb8-4185-47b9-bbb3-1c587e558a03
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1098418
  • 1114074
  • 1098416
  • 1114096
  • UPC Code
  • 0358468782038
  • 0358468784032
  • 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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