genvoya

Generic: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide

Labeler: gilead sciences, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name genvoya
Generic Name elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
Labeler gilead sciences, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cobicistat 150 mg/1, elvitegravir 150 mg/1, emtricitabine 200 mg/1, tenofovir alafenamide fumarate 10 mg/1

Manufacturer
Gilead Sciences, Inc.

Identifiers & Regulatory

Product NDC 61958-1901
Product ID 61958-1901_7bb9d232-d878-47d0-8262-abc4d06b37f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207561
Listing Expiration 2026-12-31
Marketing Start 2015-11-05

Pharmacologic Class

Established (EPC)
cytochrome p450 3a inhibitor [epc] human immunodeficiency virus integrase strand transfer inhibitor [epc] human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]
Mechanism of Action
cytochrome p450 3a inhibitors [moa] p-glycoprotein inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] organic anion transporting polypeptide 1b1 inhibitors [moa] organic anion transporting polypeptide 1b3 inhibitors [moa] breast cancer resistance protein inhibitors [moa] multidrug and toxin extrusion transporter 1 inhibitors [moa] hiv integrase inhibitors [moa] cytochrome p450 2c9 inducers [moa] nucleoside reverse transcriptase inhibitors [moa]
Chemical Structure
nucleosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 619581901
Hyphenated Format 61958-1901

Supplemental Identifiers

RxCUI
1721613 1721619
UNII
LW2E03M5PG 4GDQ854U53 G70B4ETF4S FWF6Q91TZO
NUI
N0000190114 N0000191001 N0000185503 N0000182137 N0000190107 N0000190108 N0000190113 N0000191423 N0000000127 N0000175887 N0000185507 N0000175462 M0015066 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 genvoya (source: ndc)
Generic Name elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (source: ndc)
Application Number NDA207561 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
  • 200 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (61958-1901-1)
source: ndc

Packages (1)

61958-1901-1 30 TABLET in 1 BOTTLE, PLASTIC (61958-1901-1)

Ingredients (4)

cobicistat (150 mg/1) elvitegravir (150 mg/1) emtricitabine (200 mg/1) tenofovir alafenamide fumarate (10 mg/1)

Linked Drug Pages (1)

Genvoya ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7bb9d232-d878-47d0-8262-abc4d06b37f7", "openfda": {"nui": ["N0000190114", "N0000191001", "N0000185503", "N0000182137", "N0000190107", "N0000190108", "N0000190113", "N0000191423", "N0000000127", "N0000175887", "N0000185507", "N0000175462", "M0015066", "N0000009947"], "unii": ["LW2E03M5PG", "4GDQ854U53", "G70B4ETF4S", "FWF6Q91TZO"], "rxcui": ["1721613", "1721619"], "spl_set_id": ["34784acf-15ed-4715-b504-eb30430518e9"], "pharm_class_cs": ["Nucleosides [CS]"], "pharm_class_epc": ["Cytochrome P450 3A Inhibitor [EPC]", "Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "HIV Integrase Inhibitors [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Gilead Sciences, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (61958-1901-1)", "package_ndc": "61958-1901-1", "marketing_start_date": "20151105"}], "brand_name": "Genvoya", "product_id": "61958-1901_7bb9d232-d878-47d0-8262-abc4d06b37f7", "dosage_form": "TABLET", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitor [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "HIV Integrase Inhibitors [MoA]", "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleosides [CS]", "Nucleosides [CS]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "61958-1901", "generic_name": "elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Genvoya", "active_ingredients": [{"name": "COBICISTAT", "strength": "150 mg/1"}, {"name": "ELVITEGRAVIR", "strength": "150 mg/1"}, {"name": "EMTRICITABINE", "strength": "200 mg/1"}, {"name": "TENOFOVIR ALAFENAMIDE FUMARATE", "strength": "10 mg/1"}], "application_number": "NDA207561", "marketing_category": "NDA", "marketing_start_date": "20151105", "listing_expiration_date": "20261231"}