NDC 69656-101

Varubi

Rolapitant

Varubi is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithline Llc. The primary component is Rolapitant Hydrochloride.

• Product ID: 69656-101_41a8662a-8aa7-4c63-8fc6-b29286e08ac8
• NDC: 69656-101
• Product Type: Human Prescription Drug
• Proprietary Name: Varubi
• Generic Name: Rolapitant
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-10-07
• Marketing End Date: 2021-10-31
• Marketing Category: NDA / NDA
• Application Number: NDA206500
• Labeler Name: GlaxoSmithLine LLC
• Substance Name: ROLAPITANT HYDROCHLORIDE
• Active Ingredient Strength: 90 mg/1
• 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

Packaging

NDC 69656-101-02

2 TABLET in 1 BLISTER PACK (69656-101-02)

• Marketing Start Date: 2015-10-07
• Marketing End Date: 2021-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69656-101-02 [69656010102]

Varubi TABLET

• Marketing Category: NDA
• Application Number: NDA206500
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-10-07

Drug Details

Active Ingredients

Ingredient	Strength
ROLAPITANT HYDROCHLORIDE	90 mg/1

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