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 |
Marketing Start Date | 2019-08-06 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA206500 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2019-08-06 |
Ingredient | Strength |
---|---|
ROLAPITANT HYDROCHLORIDE | 90 mg/1 |
SPL SET ID: | a52896cd-4a98-49b8-82db-bf1985a64d97 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
69656-101 | Varubi | rolapitant |
69656-102 | Varubi | rolapitant |
70720-101 | Varubi | rolapitant |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VARUBI 86591285 4893721 Live/Registered |
Tesaro, Inc. 2015-04-08 |