ODEFSEY is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Alafenamide Fumarate.
Product ID | 50090-2340_26120f57-70c4-4368-81de-9167e306a0a4 |
NDC | 50090-2340 |
Product Type | Human Prescription Drug |
Proprietary Name | ODEFSEY |
Generic Name | Emtricitabine, Rilpivirine, And Tenofovir Alafenamide |
Dosage Form | Tablet |
Route of Administration | ORAL |
Marketing Start Date | 2016-03-01 |
Marketing Category | NDA / NDA |
Application Number | NDA208351 |
Labeler Name | A-S Medication Solutions |
Substance Name | EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE |
Active Ingredient Strength | 200 mg/1; mg/1; mg/1 |
Pharm Classes | Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Non-Nucleoside Analog [EXT],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2019-12-31 |
Marketing Start Date | 2016-04-04 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA208351 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2016-04-04 |
Inactivation Date | 2020-01-31 |
Ingredient | Strength |
---|---|
EMTRICITABINE | 200 mg/1 |
SPL SET ID: | f8689541-6526-47a5-9ff5-b8fc39ef4099 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
50090-2340 | ODEFSEY | emtricitabine, rilpivirine, and tenofovir alafenamide |
61958-2101 | ODEFSEY | emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide |
70518-0695 | ODEFSEY | emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ODEFSEY 86553716 4879988 Live/Registered |
Gilead Sciences Ireland UC 2015-03-04 |