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 |