Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate

Product NDC

33342-138

11-digit product format

333420138

Labeler code

33342

Product ID

33342-138_3b244bb3-2e8b-4fde-b69d-330aca56fb8e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Macleods Pharmaceuticals Limited

Application

ANDA204287

Marketing category

ANDA

Marketing start

2021-09-13

Substance

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Active strength

600; 200; 300 mg/1; mg/1; mg/1

Pharmacologic classes

Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], 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