NDC 58468-7860

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 ID58468-7860_a8442300-a9bd-466b-ae0c-57531cf15820
NDC58468-7860
Product TypeHuman Prescription Drug
Proprietary NameCAPRELSA
Generic NameVandetanib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2022-06-24
Marketing CategoryUNAPPROVED DRUG FOR USE IN DRUG SHORTAGE /
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 58468-7860-3

3 BLISTER PACK in 1 CARTON (58468-7860-3) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2022-06-24
NDC Exclude FlagN
Sample Package?N

Drug Details

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.