varubi

Generic: rolapitant

Labeler: tersera therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name varubi
Generic Name rolapitant
Labeler tersera therapeutics llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

rolapitant hydrochloride 90 mg/1

Manufacturer
TerSera Therapeutics LLC

Identifiers & Regulatory

Product NDC 70720-101
Product ID 70720-101_5de36f8a-cbc2-4884-8fcf-e9302d41c2f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206500
Listing Expiration 2026-12-31
Marketing Start 2015-10-07

Pharmacologic Class

Classes
breast cancer resistance protein inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] neurokinin 1 antagonists [moa] p-glycoprotein inhibitors [moa] substance p/neurokinin-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70720101
Hyphenated Format 70720-101

Supplemental Identifiers

RxCUI
1665503 1673373
UPC
0370720101029
UNII
57O5S1QSAQ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name varubi (source: ndc)
Generic Name rolapitant (source: ndc)
Application Number NDA206500 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 90 mg/1
source: ndc
Packaging
  • 2 TABLET in 1 BLISTER PACK (70720-101-02)
source: ndc

Packages (1)

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

Ingredients (1)

rolapitant hydrochloride (90 mg/1)

Linked Drug Pages (1)

Varubi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5de36f8a-cbc2-4884-8fcf-e9302d41c2f8", "openfda": {"upc": ["0370720101029"], "unii": ["57O5S1QSAQ"], "rxcui": ["1665503", "1673373"], "spl_set_id": ["a52896cd-4a98-49b8-82db-bf1985a64d97"], "manufacturer_name": ["TerSera Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET in 1 BLISTER PACK (70720-101-02)", "package_ndc": "70720-101-02", "marketing_start_date": "20190806"}], "brand_name": "Varubi", "product_id": "70720-101_5de36f8a-cbc2-4884-8fcf-e9302d41c2f8", "dosage_form": "TABLET", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Neurokinin 1 Antagonists [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Substance P/Neurokinin-1 Receptor Antagonist [EPC]"], "product_ndc": "70720-101", "generic_name": "rolapitant", "labeler_name": "TerSera Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Varubi", "active_ingredients": [{"name": "ROLAPITANT HYDROCHLORIDE", "strength": "90 mg/1"}], "application_number": "NDA206500", "marketing_category": "NDA", "marketing_start_date": "20151007", "listing_expiration_date": "20261231"}