Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate

Product NDC

42385-929

11-digit product format

423850929

Labeler code

42385

Product ID

42385-929_80228c3a-152e-4170-9469-b4e13b137bcb

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Laurus Labs Limited

Application

ANDA213038

Marketing category

ANDA

Marketing start

2020-05-14

Substance

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Active strength

400; 300; 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], 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]

NDC exclude flag

No

Listing certified through

2026-12-31

Current FDA listing

Yes