stribild

Generic: elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate

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

Drug Facts

Product Profile

Brand Name stribild
Generic Name elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
Labeler gilead sciences, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cobicistat 150 mg/1, elvitegravir 150 mg/1, emtricitabine 200 mg/1, tenofovir disoproxil fumarate 300 mg/1

Manufacturer
Gilead Sciences, Inc.

Identifiers & Regulatory

Product NDC 61958-1201
Product ID 61958-1201_65c2d2eb-d180-41c3-b346-9cdc6e52d5ed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203100
Listing Expiration 2026-12-31
Marketing Start 2012-08-27

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 619581201
Hyphenated Format 61958-1201

Supplemental Identifiers

RxCUI
1306292 1306298
UNII
LW2E03M5PG 4GDQ854U53 G70B4ETF4S OTT9J7900I
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 stribild (source: ndc)
Generic Name elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (source: ndc)
Application Number NDA203100 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
  • 200 mg/1
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1201-1)
source: ndc

Packages (1)

61958-1201-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1201-1)

Ingredients (4)

cobicistat (150 mg/1) elvitegravir (150 mg/1) emtricitabine (200 mg/1) tenofovir disoproxil fumarate (300 mg/1)

Linked Drug Pages (1)

Stribild ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "65c2d2eb-d180-41c3-b346-9cdc6e52d5ed", "openfda": {"nui": ["N0000190114", "N0000191001", "N0000185503", "N0000182137", "N0000190107", "N0000190108", "N0000190113", "N0000191423", "N0000000127", "N0000175887", "N0000185507", "N0000175462", "M0015066", "N0000009947"], "unii": ["LW2E03M5PG", "4GDQ854U53", "G70B4ETF4S", "OTT9J7900I"], "rxcui": ["1306292", "1306298"], "spl_set_id": ["74ae2a93-b267-444c-8f0f-a2a6522260ee"], "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, FILM COATED in 1 BOTTLE, PLASTIC (61958-1201-1)", "package_ndc": "61958-1201-1", "marketing_start_date": "20120827"}], "brand_name": "Stribild", "product_id": "61958-1201_65c2d2eb-d180-41c3-b346-9cdc6e52d5ed", "dosage_form": "TABLET, FILM COATED", "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": "61958-1201", "generic_name": "elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Stribild", "active_ingredients": [{"name": "COBICISTAT", "strength": "150 mg/1"}, {"name": "ELVITEGRAVIR", "strength": "150 mg/1"}, {"name": "EMTRICITABINE", "strength": "200 mg/1"}, {"name": "TENOFOVIR DISOPROXIL FUMARATE", "strength": "300 mg/1"}], "application_number": "NDA203100", "marketing_category": "NDA", "marketing_start_date": "20120827", "listing_expiration_date": "20261231"}