NDC 61958-0602

Emtriva

Emtricitabine

Emtriva is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Gilead Sciences, Inc.. The primary component is Emtricitabine.

Product ID61958-0602_9ffbe70f-188c-4005-a3e1-a74dc01283d2
NDC61958-0602
Product TypeHuman Prescription Drug
Proprietary NameEmtriva
Generic NameEmtricitabine
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2005-09-28
Marketing CategoryNDA / NDA
Application NumberNDA021896
Labeler NameGilead Sciences, Inc.
Substance NameEMTRICITABINE
Active Ingredient Strength10 mg/mL
Pharm ClassesHuman Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61958-0602-1

1 BOTTLE, DISPENSING in 1 CARTON (61958-0602-1) > 170 mL in 1 BOTTLE, DISPENSING
Marketing Start Date2005-09-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61958-0602-1 [61958060201]

Emtriva SOLUTION
Marketing CategoryNDA
Application NumberNDA021896
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-09-28

Drug Details

Active Ingredients

IngredientStrength
EMTRICITABINE10 mg/mL

OpenFDA Data

SPL SET ID:d6599395-3944-44f9-97f2-e0424c6b6a1f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403875
  • 404587
  • 597291
  • 616148
  • Pharmacological Class

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

    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

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