NDC 69656-102

Varubi

Rolapitant

Varubi is a Intravenous Injection, Emulsion in the Human Prescription Drug category. It is labeled and distributed by Tesaro, Inc.. The primary component is Rolapitant.

• Product ID: 69656-102_4e6fc087-797c-49a6-905a-dcf658d60aa5
• NDC: 69656-102
• Product Type: Human Prescription Drug
• Proprietary Name: Varubi
• Generic Name: Rolapitant
• Dosage Form: Injection, Emulsion
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-10-25
• Marketing Category: NDA / NDA
• Application Number: NDA208399
• Labeler Name: Tesaro, Inc.
• Substance Name: ROLAPITANT
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69656-102-10

1 VIAL, SINGLE-DOSE in 1 CARTON (69656-102-10) > 92.5 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2017-10-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69656-102-10 [69656010210]

Varubi INJECTION, EMULSION

• Marketing Category: NDA
• Application Number: NDA208399
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-10-25

Drug Details

Active Ingredients

Ingredient	Strength
ROLAPITANT	1.8 mg/mL

OpenFDA Data

• SPL SET ID: ed3ef3f8-8cb7-40db-9d75-e728ee607760
• Manufacturer:
  • Tesaro, Inc.
• UNII:
  • 57O5S1QSAQ
  • NLE429IZUC
• RxNorm Concept Unique ID - RxCUI:
  • 1986889
  • 1665503
  • 1986885
  • 1673373

Pharmacological Class

• Neurokinin 1 Antagonists [MoA]
• Substance P/Neurokinin-1 Receptor Antagonist [EPC]
• Cytochrome P450 2D6 Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Neurokinin 1 Antagonists [MoA]
• Substance P/Neurokinin-1 Receptor Antagonist [EPC]
• Cytochrome P450 2D6 Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]

NDC Crossover Matching brand name "Varubi" or generic name "Rolapitant"

NDC	Brand Name	Generic Name
69656-101	Varubi	rolapitant
69656-102	Varubi	rolapitant
70720-101	Varubi	rolapitant