Varubi
- Product NDC
- 70720-101
- 11-digit product format
- 707200101
- Labeler code
- 70720
- Product ID
- 70720-101_5de36f8a-cbc2-4884-8fcf-e9302d41c2f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rolapitant
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TerSera Therapeutics LLC
- Application
- NDA206500
- Marketing category
- NDA
- Marketing start
- 2015-10-07
- Substance
- ROLAPITANT HYDROCHLORIDE
- Active strength
- 90 mg/1
- Pharmacologic 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]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Varubi
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROLAPITANT HYDROCHLORIDE | 90 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57O5S1QSAQ |
| Rxcui | 1665503, 1673373 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70720-101-02 | Varubi | 2 in 1 BLISTER PACK | TABLET | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70720-101 | VARUBI (ROLAPITANT) TABLET [TERSERA THERAPEUTICS LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20200829_a52896cd-4a98-49b8-82db-bf1985a64d97.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70720-101-02 | 70720010102 | 2 TABLET in 1 BLISTER PACK (70720-101-02) | 2 tablet | 2019-08-06 | 0000-00-00 | No | No | Current |