Prescription drug · NDA
Varubi (Rolapitant) NDC 70720-101
Rolapitant hydrochloride 90 mg/1 · Tablet · Oral · TerSera Therapeutics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70720-101-02 | 7072001010270720010102 | 2 TABLET in 1 BLISTER PACK (70720-101-02)Marketed from Aug 6, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Varubi
- Generic name (nonproprietary)
- rolapitant
- Active ingredients
- Rolapitant hydrochloride — 90 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TerSera Therapeutics LLCNDC labeler code 70720
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206500
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Neurokinin 1 Antagonists (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 70720-101_5de36f8a-cbc2-4884-8fcf-e9302d41c2f8SPL ID 5de36f8a-cbc2-4884-8fcf-e9302d41c2f8SPL set ID a52896cd-4a98-49b8-82db-bf1985a64d97RxCUI 1665503, 1673373UNII 57O5S1QSAQUPC 0370720101029
- Pharmacologic class
- Substance P/Neurokinin-1 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470720010102followed by a unit qualifier and the quantityPackage 70720-0101-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
VARUBI ® is indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is a substance P/neurokinin 1 (NK1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 70720-101
- What is NDC 70720-101?
- 70720-101 is the product NDC for Varubi (rolapitant), Rolapitant hydrochloride 90 mg/1 tablet, listed with the FDA by TerSera Therapeutics LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Varubi (Rolapitant).
- What is the active ingredient?
- Rolapitant hydrochloride.
- Who is the labeler?
- TerSera Therapeutics LLC, NDC labeler code 70720. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Varubi?
- 1 other product NDC are listed under this name. See all Varubi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Varubi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Varubirolapitant | Rolapitant hydrochloride 90 mg/1 | TabletOral | Luria Therapeutics LLC | 87628-101 | 87628-0101-02 |
Other NDCs under NDA 206500
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Varubirolapitant | Rolapitant hydrochloride 90 mg/1 | TabletOral | Luria Therapeutics LLC | 87628-101 |