NDC 42385-915

Efavirenz, emtricitabine and tenofovir disoproxil fumarate

Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate

Efavirenz, emtricitabine 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; Emtricitabine; Tenofovir Disoproxil Fumarate.

Product ID42385-915_aca22076-f435-4533-9fcf-566b0734c313
NDC42385-915
Product TypeHuman Prescription Drug
Proprietary NameEfavirenz, emtricitabine and tenofovir disoproxil fumarate
Generic NameEfavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2021-12-22
Marketing CategoryANDA /
Application NumberANDA213541
Labeler NameLaurus Labs Limited
Substance NameEFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active Ingredient Strength600 mg/1; mg/1; mg/1
Pharm ClassesHuman 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],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],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]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 42385-915-30

30 TABLET, FILM COATED in 1 BOTTLE (42385-915-30)
Marketing Start Date2021-12-22
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Efavirenz, emtricitabine and tenofovir disoproxil fumarate" or generic name "Efavirenz, Emtricitabine And Tenofovir Disoproxil Fumarate"

NDCBrand NameGeneric Name
0093-5234Efavirenz, Emtricitabine and Tenofovir Disoproxil FumarateEfavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
31722-736Efavirenz, Emtricitabine and Tenofovir Disoproxil FumarateEfavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
33342-138Efavirenz, Emtricitabine and Tenofovir Disoproxil FumarateEfavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
42385-915Efavirenz, emtricitabine and tenofovir disoproxil fumarateEfavirenz, emtricitabine and tenofovir disoproxil fumarate
65862-497Efavirenz, Emtricitabine And Tenofovir Disoproxil FumarateEfavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
69097-210efavirenz, emtricitabine and tenofovir disoproxil fumarateefavirenz, emtricitabine and tenofovir disoproxil fumarate
70518-2905Efavirenz, Emtricitabine and Tenofovir Disoproxil FumarateEfavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate
76282-678efavirenz, emtricitabine and tenofovir disoproxil fumarateefavirenz, emtricitabine and tenofovir disoproxil fumarate

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