ODEFSEY
- Product NDC
- 70518-0695
- 11-digit product format
- 705180695
- Labeler code
- 70518
- Product ID
- 70518-0695_8ac774f9-6358-64cb-e053-2995a90a9fa7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA208351
- Marketing category
- NDA
- Marketing start
- 2017-08-17
- Marketing end
- 0000-00-00
- Substance
- EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
- Active strength
- 200 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 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [EXT],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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record