ODEFSEY

Product NDC

50090-2340

11-digit product format

500902340

Labeler code

50090

Product ID

50090-2340_26120f57-70c4-4368-81de-9167e306a0a4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

emtricitabine, rilpivirine, and tenofovir alafenamide

Dosage form

TABLET

Route

ORAL

Labeler

A-S Medication Solutions

Application

NDA208351

Marketing category

NDA

Marketing start

2016-03-01

Marketing end

0000-00-00

Substance

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE

Active strength

200 mg/1; mg/1; mg/1

Pharmacologic 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

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record