caprelsa

Generic: vandetanib

Labeler: genzyme corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name caprelsa
Generic Name vandetanib
Labeler genzyme corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

vandetanib 100 mg/1

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-7820
Product ID 58468-7820_cf08f2bd-2d9a-4129-b2d7-06a79983bd20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022405
Listing Expiration 2027-12-31
Marketing Start 2011-07-25

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
protein kinase inhibitors [moa] p-glycoprotein inhibitors [moa] organic cation transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584687820
Hyphenated Format 58468-7820

Supplemental Identifiers

RxCUI
1098416 1098418 1114074 1114096
UNII
YO460OQ37K
NUI
N0000175605 N0000175076 N0000185503 N0000187061

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name caprelsa (source: ndc)
Generic Name vandetanib (source: ndc)
Application Number NDA022405 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (58468-7820-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

58468-7820-3 1 BOTTLE, PLASTIC in 1 CARTON (58468-7820-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

vandetanib (100 mg/1)

Linked Drug Pages (1)

CAPRELSA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cf08f2bd-2d9a-4129-b2d7-06a79983bd20", "openfda": {"nui": ["N0000175605", "N0000175076", "N0000185503", "N0000187061"], "unii": ["YO460OQ37K"], "rxcui": ["1098416", "1098418", "1114074", "1114096"], "spl_set_id": ["e5721cb8-4185-47b9-bbb3-1c587e558a03"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58468-7820-3)  / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "58468-7820-3", "marketing_start_date": "20110725"}], "brand_name": "CAPRELSA", "product_id": "58468-7820_cf08f2bd-2d9a-4129-b2d7-06a79983bd20", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Organic Cation Transporter 2 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "58468-7820", "generic_name": "Vandetanib", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CAPRELSA", "active_ingredients": [{"name": "VANDETANIB", "strength": "100 mg/1"}], "application_number": "NDA022405", "marketing_category": "NDA", "marketing_start_date": "20110725", "listing_expiration_date": "20271231"}