NDC 53808-0801

Emtriva

Emtricitabine

Emtriva is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Emtricitabine.

Product ID53808-0801_cbe7f06f-5d03-478a-b878-e9149a9cc853
NDC53808-0801
Product TypeHuman Prescription Drug
Proprietary NameEmtriva
Generic NameEmtricitabine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2009-07-01
Marketing CategoryNDA / NDA
Application NumberNDA021500
Labeler NameState of Florida DOH Central Pharmacy
Substance NameEMTRICITABINE
Active Ingredient Strength200 mg/1
Pharm ClassesNucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 53808-0801-1

30 CAPSULE in 1 BLISTER PACK (53808-0801-1)
Marketing Start Date2009-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53808-0801-1 [53808080101]

Emtriva CAPSULE
Marketing CategoryNDA
Application NumberNDA021500
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
EMTRICITABINE200 mg/1

OpenFDA Data

SPL SET ID:d99086c9-41a4-4c69-b41a-80054e828095
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403875
  • 404587
  • Pharmacological Class

    • Nucleoside Analog [EXT]
    • Nucleoside Reverse Transcriptase Inhibitors [MoA]
    • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]

    NDC Crossover Matching brand name "Emtriva" or generic name "Emtricitabine"

    NDCBrand NameGeneric Name
    46014-0601Emtrivaemtricitabine
    53808-0801Emtrivaemtricitabine
    61958-0601EmtrivaEMTRICITABINE
    61958-0602EmtrivaEMTRICITABINE
    70518-1847EmtrivaEMTRICITABINE
    69097-642emtricitabineemtricitabine
    70518-2906emtricitabineemtricitabine

    Trademark Results [Emtriva]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EMTRIVA
    EMTRIVA
    78239710 2852092 Live/Registered
    Gilead Sciences, Inc.
    2003-04-18

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