NDC 70720-101

Varubi

Rolapitant

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

• Product ID: 70720-101_5de36f8a-cbc2-4884-8fcf-e9302d41c2f8
• NDC: 70720-101
• 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 Category: NDA / NDA
• Application Number: NDA206500
• Labeler Name: TerSera Therapeutics 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
• Listing Certified Through: 2021-12-31

Packaging

NDC 70720-101-02

2 TABLET in 1 BLISTER PACK (70720-101-02)

• Marketing Start Date: 2019-08-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70720-101-02 [70720010102]

Varubi TABLET

• Marketing Category: NDA
• Application Number: NDA206500
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-06

Drug Details

Active Ingredients

Ingredient	Strength
ROLAPITANT HYDROCHLORIDE	90 mg/1

OpenFDA Data

• SPL SET ID: a52896cd-4a98-49b8-82db-bf1985a64d97
• Manufacturer:
  • TerSera Therapeutics LLC
• UNII:
  • 57O5S1QSAQ
• RxNorm Concept Unique ID - RxCUI:
  • 1665503
  • 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