NDC product

Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate

NDC 33342-138 · Macleods Pharmaceuticals Limited

Key facts

Product NDC 33342-138
Proprietary name Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
Nonproprietary name Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
Substances EFAVIRENZ, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA204287
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] and 6 more
Marketing start Sep 13, 2021
Listing certified through Dec 31, 2026

At a glance

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Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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