symfi

Generic: efavirenz, lamivudine and tenofovir disoproxil fumarate

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name symfi
Generic Name efavirenz, lamivudine and tenofovir disoproxil fumarate
Labeler viatris specialty llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

efavirenz 600 mg/1, lamivudine 300 mg/1, tenofovir disoproxil fumarate 300 mg/1

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 49502-475
Product ID 49502-475_0a09befe-6075-4bef-bd45-0e41082559d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022142
Listing Expiration 2026-12-31
Marketing Start 2018-04-25

Pharmacologic Class

Established (EPC)
human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor [epc] hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc] human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
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] nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49502475
Hyphenated Format 49502-475

Supplemental Identifiers

RxCUI
864661 2043464
UPC
0349502475931
UNII
JE6H2O27P8 2T8Q726O95 OTT9J7900I
NUI
N0000175463 N0000175460 N0000009948 N0000190118 N0000187064 N0000185504 N0000182140 N0000182141 N0000175656 N0000175462 N0000009947

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name symfi (source: ndc)
Generic Name efavirenz, lamivudine and tenofovir disoproxil fumarate (source: ndc)
Application Number NDA022142 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (49502-475-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

49502-475-93 1 BOTTLE, PLASTIC in 1 CARTON (49502-475-93) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Ingredients (3)

efavirenz (600 mg/1) lamivudine (300 mg/1) tenofovir disoproxil fumarate (300 mg/1)

Linked Drug Pages (1)

SYMFI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0a09befe-6075-4bef-bd45-0e41082559d8", "openfda": {"nui": ["N0000175463", "N0000175460", "N0000009948", "N0000190118", "N0000187064", "N0000185504", "N0000182140", "N0000182141", "N0000175656", "N0000175462", "N0000009947"], "upc": ["0349502475931"], "unii": ["JE6H2O27P8", "2T8Q726O95", "OTT9J7900I"], "rxcui": ["864661", "2043464"], "spl_set_id": ["81a55dd9-78a8-49c3-88ab-8f5bffafa359"], "pharm_class_epc": ["Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["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]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (49502-475-93)  / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "49502-475-93", "marketing_start_date": "20180425"}], "brand_name": "SYMFI", "product_id": "49502-475_0a09befe-6075-4bef-bd45-0e41082559d8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]", "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Non-Nucleoside Analog [EXT]", "Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]"], "product_ndc": "49502-475", "generic_name": "Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SYMFI", "active_ingredients": [{"name": "EFAVIRENZ", "strength": "600 mg/1"}, {"name": "LAMIVUDINE", "strength": "300 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "NDA022142", "marketing_category": "NDA", "marketing_start_date": "20180425", "listing_expiration_date": "20261231"}