NDC 42385-928

Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate

Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate

Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Laurus Labs Limited. The primary component is Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate.

Product ID42385-928_1f8f9fe1-b8fd-4f65-8832-9d3d6802d076
NDC42385-928
Product TypeHuman Prescription Drug
Proprietary NameEfavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
Generic NameEfavirenz, Lamivudine And Tenofovir Disoproxil Fumarate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-05-14
Marketing CategoryANDA / ANDA
Application NumberANDA212786
Labeler NameLaurus Labs Limited
Substance NameEFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Active Ingredient Strength600 mg/1; mg/1; mg/1
Pharm ClassesHepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 42385-928-30

30 TABLET, FILM COATED in 1 BOTTLE (42385-928-30)
Marketing Start Date2020-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42385-928-30 [42385092830]

Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA212786
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-14

NDC 42385-928-90 [42385092890]

Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA212786
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-14

Drug Details

NDC Crossover Matching brand name "Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate" or generic name "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate"

NDCBrand NameGeneric Name
33342-362efavirenz, lamivudine and tenofovir disoproxil fumarateefavirenz, lamivudine and tenofovir disoproxil fumarate
42385-928Efavirenz, Lamivudine and Tenofovir Disoproxil FumarateEfavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
42385-929Efavirenz, Lamivudine and Tenofovir Disoproxil FumarateEfavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
49502-475SYMFIEfavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
49502-425SYMFI LOEfavirenz, Lamivudine and Tenofovir Disoproxil Fumarate

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