Biktarvy is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Gilead Sciences, Inc.. The primary component is Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate.
| Product ID | 61958-2505_12754803-c0a0-4971-8c17-8348aab6a417 | 
| NDC | 61958-2505 | 
| Product Type | Human Prescription Drug | 
| Proprietary Name | Biktarvy | 
| Generic Name | Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate | 
| Dosage Form | Tablet | 
| Route of Administration | ORAL | 
| Marketing Start Date | 2021-10-07 | 
| Marketing Category | NDA / | 
| Application Number | NDA210251 | 
| Labeler Name | Gilead Sciences, Inc. | 
| Substance Name | BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | 
| Active Ingredient Strength | 30 mg/1; mg/1; mg/1 | 
| Pharm Classes | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS] | 
| NDC Exclude Flag | N | 
| Listing Certified Through | 2023-12-31 | 
| Marketing Start Date | 2021-10-07 | 
| NDC Exclude Flag | N | 
| Sample Package? | N | 
| NDC | Brand Name | Generic Name | 
|---|---|---|
| 50090-6247 | Biktarvy | bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | 
| 61958-2501 | Biktarvy | bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | 
| 61958-2505 | Biktarvy | bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | 
| 70518-3080 | Biktarvy | bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  BIKTARVY  87226465  5344455 Live/Registered | Gilead Sciences Ireland UC 2016-11-04 |