Vosevi
- Product NDC
- 61958-2401
- 11-digit product format
- 619582401
- Labeler code
- 61958
- Product ID
- 61958-2401_6ce7dd60-defa-4530-bff3-de03885e318a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SOFOSBUVIR, VELPATASVIR, and VOXILAPREVIR
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Gilead Sciences, Inc.
- Application
- NDA209195
- Marketing category
- NDA
- Marketing start
- 2017-07-18
- Substance
- SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
- Active strength
- 400; 100; 100 mg/1; mg/1; mg/1
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], HCV NS3/4A Protease Inhibitors [MoA], Hepatitis C Virus NS3/4A Protease Inhibitor [EPC], Hepatitis C Virus NS5A Inhibitor [EPC], Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], RNA Replicase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Vosevi
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOFOSBUVIR | 400 mg/1 |
| VELPATASVIR | 100 mg/1 |
| VOXILAPREVIR | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WJ6CA3ZU8B, KCU0C7RS7Z, 0570F37359 |
| Rxcui | 1939329, 1939335 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61958-2401-1 | Vosevi | 28 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 28 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61958-2401 | VOSEVI (SOFOSBUVIR, VELPATASVIR, AND VOXILAPREVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240316_17ffc094-8ca7-45d2-80d8-fd043bc9a221.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61958-2401-1 | 61958240101 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2401-1) | 2017-07-18 | 0000-00-00 | No | No | Current |