symtuza

Generic: darunavir, cobicistat, emtricitabine, and tenofovir alafenamide

Labeler: janssen products lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name symtuza
Generic Name darunavir, cobicistat, emtricitabine, and tenofovir alafenamide
Labeler janssen products lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cobicistat 150 mg/1, darunavir 800 mg/1, emtricitabine 200 mg/1, tenofovir alafenamide 10 mg/1

Manufacturer
Janssen Products LP

Identifiers & Regulatory

Product NDC 59676-800
Product ID 59676-800_1df0f724-b54d-bf96-e063-6294a90a79bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210455
Listing Expiration 2026-12-31
Marketing Start 2018-07-17

Pharmacologic Class

Established (EPC)
cytochrome p450 3a inhibitor [epc] protease 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 protease inhibitors [moa] nucleoside reverse transcriptase inhibitors [moa]
Chemical Structure
nucleosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59676800
Hyphenated Format 59676-800

Supplemental Identifiers

RxCUI
2049671 2049677
UPC
0359676800309
UNII
LW2E03M5PG YO603Y8113 G70B4ETF4S EL9943AG5J
NUI
N0000190114 N0000191001 N0000185503 N0000182137 N0000190107 N0000190108 N0000190113 N0000191423 N0000000246 N0000175889 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 symtuza (source: ndc)
Generic Name darunavir, cobicistat, emtricitabine, and tenofovir alafenamide (source: ndc)
Application Number NDA210455 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
  • 800 mg/1
  • 200 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30)
  • 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-99)
source: ndc

Packages (2)

59676-800-30 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30) 59676-800-99 30 TABLET, FILM COATED in 1 BOTTLE (59676-800-99)

Ingredients (4)

cobicistat (150 mg/1) darunavir (800 mg/1) emtricitabine (200 mg/1) tenofovir alafenamide (10 mg/1)

Linked Drug Pages (1)

Symtuza ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1df0f724-b54d-bf96-e063-6294a90a79bc", "openfda": {"nui": ["N0000190114", "N0000191001", "N0000185503", "N0000182137", "N0000190107", "N0000190108", "N0000190113", "N0000191423", "N0000000246", "N0000175889", "N0000175462", "M0015066", "N0000009947"], "upc": ["0359676800309"], "unii": ["LW2E03M5PG", "YO603Y8113", "G70B4ETF4S", "EL9943AG5J"], "rxcui": ["2049671", "2049677"], "spl_set_id": ["85a17d00-6b7c-41ea-a6b3-5ad924820dab"], "pharm_class_cs": ["Nucleosides [CS]"], "pharm_class_epc": ["Cytochrome P450 3A Inhibitor [EPC]", "Protease 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 Protease Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Janssen Products LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (59676-800-30)", "package_ndc": "59676-800-30", "marketing_start_date": "20180717"}, {"sample": true, "description": "30 TABLET, FILM COATED in 1 BOTTLE (59676-800-99)", "package_ndc": "59676-800-99", "marketing_start_date": "20180717"}], "brand_name": "Symtuza", "product_id": "59676-800_1df0f724-b54d-bf96-e063-6294a90a79bc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitor [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "HIV Protease Inhibitors [MoA]", "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase 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]", "Protease Inhibitor [EPC]"], "product_ndc": "59676-800", "generic_name": "Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide", "labeler_name": "Janssen Products LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Symtuza", "active_ingredients": [{"name": "COBICISTAT", "strength": "150 mg/1"}, {"name": "DARUNAVIR", "strength": "800 mg/1"}, {"name": "EMTRICITABINE", "strength": "200 mg/1"}, {"name": "TENOFOVIR ALAFENAMIDE", "strength": "10 mg/1"}], "application_number": "NDA210455", "marketing_category": "NDA", "marketing_start_date": "20180717", "listing_expiration_date": "20261231"}