COMPLERA

Product NDC

50090-1248

11-digit product format

500901248

Labeler code

50090

Product ID

50090-1248_5b88be70-8056-442d-8fac-a374f029e06a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

A-S Medication Solutions

Application

NDA202123

Marketing category

NDA

Marketing start

2011-08-10

Marketing end

0000-00-00

Substance

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL 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