NDC 33342-362

efavirenz, lamivudine and tenofovir disoproxil fumarate

Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate

efavirenz, lamivudine and tenofovir disoproxil fumarate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Macleods Pharmaceuticals Limited. The primary component is Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate.

• Product ID: 33342-362_648bf898-b7be-497c-b935-cfa5c057b318
• NDC: 33342-362
• Product Type: Human Prescription Drug
• Proprietary Name: efavirenz, lamivudine and tenofovir disoproxil fumarate
• Generic Name: Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-03-29
• Marketing Category: NDA / NDA
• Application Number: NDA210649
• Labeler Name: Macleods Pharmaceuticals Limited
• Substance Name: EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
• Active Ingredient Strength: 400 mg/1; mg/1; mg/1
• Pharm Classes: 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],Hepatitis 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],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 33342-362-10

90 TABLET in 1 BOTTLE (33342-362-10)

• Marketing Start Date: 2019-03-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 33342-362-57 [33342036257]

efavirenz, lamivudine and tenofovir disoproxil fumarate TABLET

• Marketing Category: NDA
• Application Number: NDA210649
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-29
• Marketing End Date: 2019-12-26

NDC 33342-362-10 [33342036210]

efavirenz, lamivudine and tenofovir disoproxil fumarate TABLET

• Marketing Category: NDA
• Application Number: NDA210649
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-29
• Marketing End Date: 2019-12-26

NDC 33342-362-07 [33342036207]

efavirenz, lamivudine and tenofovir disoproxil fumarate TABLET

• Marketing Category: NDA
• Application Number: NDA210649
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-03-29
• Marketing End Date: 2019-12-26

Drug Details

Active Ingredients

Ingredient	Strength
EFAVIRENZ	400 mg/1

OpenFDA Data

• SPL SET ID: 648bf898-b7be-497c-b935-cfa5c057b318
• Manufacturer:
  • Macleods Pharmaceuticals Limited
• UNII:
  • OTT9J7900I
  • JE6H2O27P8
  • 2T8Q726O95
• RxNorm Concept Unique ID - RxCUI:
  • 2001424
• UPC Code:
  • 0333342362070
  • 0333342362100
  • 0333342362575

Pharmacological Class

• 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]
• Hepatitis 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]
• Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Nucleoside Analog [EXT]
• Nucleoside Reverse Transcriptase Inhibitors [MoA]
• Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]

NDC Crossover Matching brand name "efavirenz, lamivudine and tenofovir disoproxil fumarate" or generic name "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate"

NDC	Brand Name	Generic Name
33342-362	efavirenz, lamivudine and tenofovir disoproxil fumarate	efavirenz, lamivudine and tenofovir disoproxil fumarate
42385-928	Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate	Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
42385-929	Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate	Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
49502-475	SYMFI	Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
49502-425	SYMFI LO	Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate