Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate

Product NDC

0378-5440

11-digit product format

003785440

Labeler code

0378

Product ID

0378-5440_d9a4185e-43fa-4aeb-9b0f-8db01b166038

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA208452

Marketing category

ANDA

Marketing start

2025-05-27

Substance

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE

Active strength

200; 25; 300 mg/1; mg/1; mg/1

Pharmacologic classes

Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]

NDC exclude flag

No

Listing certified through

2026-12-31

Current FDA listing

Yes