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 ID: 0310-7820_e7eebdc7-a867-4d35-9b5b-2c1829a4e778
• NDC: 0310-7820
• Product Type: Human Prescription Drug
• Proprietary Name: CAPRELSA
• Generic Name: Vandetanib
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2011-07-25
• Marketing End Date: 2020-05-31
• Marketing Category: NDA / NDA
• Application Number: NDA022405
• Labeler Name: AstraZeneca Pharmaceuticals LP
• Substance Name: VANDETANIB
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
• NDC Exclude Flag: N

Packaging

NDC 0310-7820-30

30 TABLET in 1 BOTTLE, PLASTIC (0310-7820-30)

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

NDC SPL Data Element Entries

NDC 0310-7820-30 [00310782030]

CAPRELSA TABLET

• Marketing Category: NDA
• Application Number: NDA022405
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-07-25
• Marketing End Date: 2020-05-31

Drug Details

Active Ingredients

Ingredient	Strength
VANDETANIB	100 mg/1

OpenFDA Data

• SPL SET ID: 4dc7f0af-77fb-4eec-46b9-dd1c2dcb4525
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • YO460OQ37K
• 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"

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