Biktarvy is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate.
| Product ID | 70518-3080_c109cddc-e382-3c5c-e053-2a95a90a455a |
| NDC | 70518-3080 |
| 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 | 2021-04-28 |
| Marketing Category | NDA / |
| Application Number | NDA210251 |
| Labeler Name | REMEDYREPACK INC. |
| Substance Name | BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
| Active Ingredient Strength | 50 mg/1; mg/1; mg/1 |
| Pharm Classes | Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-04-28 |
| 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 |