Prescription drug · NDA
Vosevi NDC 61958-2401
sofosbuvir, velpatasvir, and voxilaprevir · Sofosbuvir 400 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Gilead Sciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61958-2401-1 | 61958240101 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2401-1)Marketed from Jul 18, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Vosevi
- Generic name (nonproprietary)
- sofosbuvir, velpatasvir, and voxilaprevir
- Active ingredients
- Sofosbuvir — 400 mg/1Velpatasvir — 100 mg/1Voxilaprevir — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Gilead Sciences, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209195
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Breast Cancer Resistance Protein Inhibitors (Mechanism)HCV NS3/4A Protease Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 2B1 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)RNA Replicase Inhibitors (Mechanism)
- Identifiers
- Product ID 61958-2401_6ce7dd60-defa-4530-bff3-de03885e318aSPL ID 6ce7dd60-defa-4530-bff3-de03885e318aSPL set ID 17ffc094-8ca7-45d2-80d8-fd043bc9a221RxCUI 1939329, 1939335UNII WJ6CA3ZU8B, KCU0C7RS7Z, 0570F37359
- Pharmacologic class
- Hepatitis C Virus NS3/4A Protease Inhibitor; Hepatitis C Virus NS5A Inhibitor; Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
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
N461958240101followed by a unit qualifier and the quantityPackage 61958-2401-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
VOSEVI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have [see Dosage and Administration (2.2) and Clinical Studies (14) ]: genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor. genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. Additional benefit of VOSEVI over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor. VOSEVI is a fixed-dose …
Excerpt only. Read the full label for complete information.