NDC 58468-7820

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 ID: 58468-7820_1b138df2-ee22-47e9-aa69-06445ff56eed
• NDC: 58468-7820
• Product Type: Human Prescription Drug
• Proprietary Name: CAPRELSA
• Generic Name: Vandetanib
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-07-25
• Marketing Category: NDA / NDA
• Application Number: NDA022405
• Labeler Name: Genzyme Corporation
• Substance Name: VANDETANIB
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Kinase Inhibitor [EPC], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 58468-7820-3

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

• Marketing Start Date: 2011-07-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58468-7820-3 [58468782003]

CAPRELSA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022405
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-07-25

Drug Details

Active Ingredients

Ingredient	Strength
VANDETANIB	100 mg/1

OpenFDA Data

• SPL SET ID: e5721cb8-4185-47b9-bbb3-1c587e558a03
• Manufacturer:
  • Genzyme Corporation
• UNII:
  • YO460OQ37K
• 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"

NDC	Brand Name	Generic Name
0310-7820	CAPRELSA	Vandetanib
0310-7840	CAPRELSA	Vandetanib
58468-7820	CAPRELSA	Vandetanib
58468-7840	CAPRELSA	Vandetanib
58468-7860	CAPRELSA	Vandetanib