NDC 70518-0097

Truvada

Emtricitabine And Tenofovir Disoproxil Fumarate

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

Product ID70518-0097_81db6b11-1632-7a3d-e053-2a91aa0a44a6
NDC70518-0097
Product TypeHuman Prescription Drug
Proprietary NameTruvada
Generic NameEmtricitabine And Tenofovir Disoproxil Fumarate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-01-03
Marketing CategoryNDA / NDA
Application NumberNDA021752
Labeler NameREMEDYREPACK INC.
Substance NameEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active Ingredient Strength200 mg/1; mg/1
Pharm ClassesNucleoside 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]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0097-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0097-0)
Marketing Start Date2016-12-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0097-1 [70518009701]

Truvada TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021752
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-22

NDC 70518-0097-2 [70518009702]

Truvada TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021752
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-24
Marketing End Date2020-04-19

NDC 70518-0097-0 [70518009700]

Truvada TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021752
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-03

Drug Details

Active Ingredients

IngredientStrength
EMTRICITABINE200 mg/1

OpenFDA Data

SPL SET ID:62c727c2-27aa-486b-9adc-175c44560cd2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 639888
  • 476556

    • 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]

    NDC Crossover Matching brand name "Truvada" or generic name "Emtricitabine And Tenofovir Disoproxil Fumarate"

    NDCBrand NameGeneric Name
    35356-070Truvadaemtricitabine and tenofovir disoproxil fumarate
    50090-0870Truvadaemtricitabine and tenofovir disoproxil fumarate
    52959-969Truvadaemtricitabine and tenofovir disoproxil fumarate
    53808-0805Truvadaemtricitabine and tenofovir disoproxil fumarate
    61919-669TRUVADAemtricitabine and tenofovir disoproxil fumarate
    61958-0701Truvadaemtricitabine and tenofovir disoproxil fumarate
    68071-2112TruvadaTruvada
    69189-0701TruvadaTruvada
    70518-0097TruvadaTruvada
    61958-0704TruvadaTruvada
    61958-0705TruvadaTruvada
    61958-0703TruvadaTruvada
    63629-7581TruvadaTruvada
    67296-1237TruvadaTruvada
    0093-7607Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
    0093-7704Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
    0378-1930Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
    0904-7172Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
    16714-534Emtricitabine and tenofovir disoproxil fumarateEmtricitabine and tenofovir disoproxil fumarate
    31722-560Emtricitabine and tenofovir disoproxil fumarateEmtricitabine and tenofovir disoproxil fumarate
    33342-106Emtricitabine and tenofovir disoproxil fumarateEmtricitabine and tenofovir disoproxil fumarate
    42291-439Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
    42385-913Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
    42385-953Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
    42543-719Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE and TENOFOVIR Disoproxil Fumarate
    50090-5957EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
    51407-112Emtricitabine and Tenofovir Disoproxil FumarateEMTRICITABINE and TENOFOVIR Disoproxil Fumarate
    60219-2092Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
    60219-2093Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
    60219-2094Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
    60219-2095Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate
    60505-4202Emtricitabine and Tenofovir Disoproxil Fumarateemtricitabine and tenofovir disoproxil fumarate

    Trademark Results [Truvada]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TRUVADA
    TRUVADA
    78239720 2915213 Live/Registered
    Gilead Sciences, Inc.
    2003-04-18
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