NDC 0078-0670

VOTRIENT

Pazopanib Hydrochloride

VOTRIENT is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Pazopanib Hydrochloride.

• Product ID: 0078-0670_0cac337d-43d8-4ab5-a204-b0ca33fd6d20
• NDC: 0078-0670
• Product Type: Human Prescription Drug
• Proprietary Name: VOTRIENT
• Generic Name: Pazopanib Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2016-07-12
• Marketing Category: NDA / NDA
• Application Number: NDA022465
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: PAZOPANIB HYDROCHLORIDE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0078-0670-66

120 TABLET, FILM COATED in 1 BOTTLE (0078-0670-66)

• Marketing Start Date: 2016-07-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0670-66 [00078067066]

VOTRIENT TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022465
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-12

Drug Details

Active Ingredients

Ingredient	Strength
PAZOPANIB HYDROCHLORIDE	200 mg/1

OpenFDA Data

• SPL SET ID: eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 33Y9ANM545
• RxNorm Concept Unique ID - RxCUI:
  • 867506
  • 867502

Pharmacological Class

• Kinase Inhibitor [EPC]
• Protein Kinase Inhibitors [MoA]
• Cytochrome P450 3A4 Inhibitors [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]
• Cytochrome P450 2C8 Inhibitors [MoA]

NDC Crossover Matching brand name "VOTRIENT" or generic name "Pazopanib Hydrochloride"

NDC	Brand Name	Generic Name
0078-0670	VOTRIENT	pazopanib hydrochloride
0078-1077	VOTRIENT	pazopanib hydrochloride