NDC 49502-425

SYMFI LO

Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate

SYMFI LO is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Specialty L.p.. The primary component is Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate.

• Product ID: 49502-425_28b7968a-0ce5-46f3-bbb5-f8acfda3da89
• NDC: 49502-425
• Product Type: Human Prescription Drug
• Proprietary Name: SYMFI LO
• Generic Name: Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-03-13
• Marketing Category: NDA / NDA
• Application Number: NDA208255
• Labeler Name: Mylan Specialty L.P.
• 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: 2021-12-31

Packaging

NDC 49502-425-93

1 BOTTLE, PLASTIC in 1 CARTON (49502-425-93) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2018-03-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49502-425-93 [49502042593]

SYMFI LO TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA208255
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-03-13

Drug Details

Active Ingredients

Ingredient	Strength
EFAVIRENZ	400 mg/1

OpenFDA Data

• SPL SET ID: 86aad85d-5460-4c38-9761-a225e6bce190
• Manufacturer:
  • Mylan Specialty L.P.
• UNII:
  • OTT9J7900I
  • JE6H2O27P8
  • 2T8Q726O95
• RxNorm Concept Unique ID - RxCUI:
  • 2001424
  • 2001430

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 "SYMFI LO" or generic name "Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate"

NDC	Brand Name	Generic Name
49502-425	SYMFI LO	Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
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