NDC 61958-1201

Stribild

Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate

Stribild is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Gilead Sciences, Inc.. The primary component is Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate.

Product ID61958-1201_8c36d9fb-28e9-4d73-851b-968d9752a3d4
NDC61958-1201
Product TypeHuman Prescription Drug
Proprietary NameStribild
Generic NameElvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-08-27
Marketing CategoryNDA / NDA
Application NumberNDA203100
Labeler NameGilead Sciences, Inc.
Substance NameELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active Ingredient Strength150 mg/1; mg/1; mg/1; mg/1
Pharm ClassesHIV Integrase Inhibitors [MoA],Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],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],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 61958-1201-1

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1201-1)
Marketing Start Date2012-08-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61958-1201-1 [61958120101]

Stribild TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA203100
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-27

Drug Details

Active Ingredients

IngredientStrength
ELVITEGRAVIR150 mg/1

OpenFDA Data

SPL SET ID:74ae2a93-b267-444c-8f0f-a2a6522260ee
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1306298
  • 1306292
  • UPC Code
  • 0361958120111
  • Pharmacological Class

    • HIV Integrase Inhibitors [MoA]
    • Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]
    • Cytochrome P450 2C9 Inducers [MoA]
    • Cytochrome P450 3A Inhibitors [MoA]
    • Cytochrome P450 3A Inhibitor [EPC]
    • 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]
    • Nucleoside Analog [EXT]
    • Nucleoside Reverse Transcriptase Inhibitors [MoA]
    • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    • 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]
    • HIV Integrase Inhibitors [MoA]
    • Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]
    • Cytochrome P450 2C9 Inducers [MoA]
    • Cytochrome P450 3A Inhibitors [MoA]
    • Cytochrome P450 3A Inhibitor [EPC]
    • 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]
    • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    • Nucleosides [CS]
    • Nucleoside Reverse Transcriptase Inhibitors [MoA]
    • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    • Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    • Nucleosides [CS]
    • Nucleoside Reverse Transcriptase Inhibitors [MoA]

    Medicade Reported Pricing

    61958120101 STRIBILD TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Stribild" or generic name "Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate"

    NDCBrand NameGeneric Name
    50090-1318Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
    53808-0887Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
    61958-1201Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
    69189-1201Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate
    70518-0674Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate

    Trademark Results [Stribild]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    STRIBILD
    STRIBILD
    85688699 4320307 Live/Registered
    GILEAD SCIENCES IRELAND UC
    2012-07-27
    STRIBILD
    STRIBILD
    85555217 4263613 Live/Registered
    GILEAD SCIENCES IRELAND UC
    2012-02-28

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.