NDC 61958-2301

VEMLIDY

Tenofovir Alafenamide

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

Product ID61958-2301_071939d1-7479-4b7c-bde2-eff9f1019017
NDC61958-2301
Product TypeHuman Prescription Drug
Proprietary NameVEMLIDY
Generic NameTenofovir Alafenamide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-11-10
Marketing CategoryNDA / NDA
Application NumberNDA208464
Labeler NameGilead Sciences, Inc.
Substance NameTENOFOVIR ALAFENAMIDE FUMARATE
Active Ingredient Strength25 mg/1
Pharm ClassesHepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 61958-2301-1

30 TABLET in 1 BOTTLE, PLASTIC (61958-2301-1)
Marketing Start Date2016-11-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61958-2301-1 [61958230101]

VEMLIDY TABLET
Marketing CategoryNDA
Application NumberNDA208464
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-10

Drug Details

Active Ingredients

IngredientStrength
TENOFOVIR ALAFENAMIDE FUMARATE25 mg/1

OpenFDA Data

SPL SET ID:72e6b33c-0351-4070-9172-eeaa186c01d2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1858261
  • 1858267
  • UPC Code
  • 0361958230117
  • Pharmacological Class

    • 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

    61958230101 VEMLIDY 25 MG TABLET

    Pricing Unit: EA | Drug Type:

    Trademark Results [VEMLIDY]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VEMLIDY
    VEMLIDY
    86765021 5001852 Live/Registered
    Gilead Sciences Ireland UC
    2015-09-22

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