Biktarvy
- Product NDC
- 70518-3080
- 11-digit product format
- 705183080
- Labeler code
- 70518
- Product ID
- 70518-3080_c71bbdf7-528d-aaf8-e053-2a95a90a271d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA210251
- Marketing category
- NDA
- Marketing start
- 2021-04-28
- Marketing end
- 0000-00-00
- Substance
- BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
- Active strength
- 50 mg/1; mg/1; mg/1
- Pharmacologic 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
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3080-0 | 70518308000 | 3 TABLET in 1 BLISTER PACK (70518-3080-0) | 3 tablet | 2021-04-28 | 0000-00-00 | No | No | Current |
| 70518-3080-1 | 70518308001 | 30 POUCH in 1 BOX (70518-3080-1) > 1 TABLET in 1 POUCH (70518-3080-2) | 30 pouch | 2021-07-14 | 0000-00-00 | No | No | Current |