NDC 61958-2501

Biktarvy

Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate

Biktarvy is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Gilead Sciences, Inc.. The primary component is Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate.

Product ID61958-2501_033019c1-648b-4694-88dd-a56bd4899d5c
NDC61958-2501
Product TypeHuman Prescription Drug
Proprietary NameBiktarvy
Generic NameBictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-02-07
Marketing CategoryNDA / NDA
Application NumberNDA210251
Labeler NameGilead Sciences, Inc.
Substance NameBICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Active Ingredient Strength50 mg/1; mg/1; mg/1
Pharm ClassesHuman 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 Through2020-12-31

Packaging

NDC 61958-2501-1

30 TABLET in 1 BOTTLE, PLASTIC (61958-2501-1)
Marketing Start Date2018-02-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61958-2501-2 [61958250102]

Biktarvy TABLET
Marketing CategoryNDA
Application NumberNDA210251
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-26

NDC 61958-2501-1 [61958250101]

Biktarvy TABLET
Marketing CategoryNDA
Application NumberNDA210251
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-07

Drug Details

Active Ingredients

IngredientStrength
BICTEGRAVIR SODIUM50 mg/1

OpenFDA Data

SPL SET ID:664cb8f0-1f65-441b-b0d9-ba3d798be309
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1999667
  • 1999673
  • Pharmacological Class

    • 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]

    Medicade Reported Pricing

    61958250101 BIKTARVY 50-200-25 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Biktarvy" or generic name "Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate"

    NDCBrand NameGeneric Name
    61958-2501Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
    70518-3080Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate

    Trademark Results [Biktarvy]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BIKTARVY
    BIKTARVY
    87226465 5344455 Live/Registered
    Gilead Sciences Ireland UC
    2016-11-04

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