NDC 42385-901

Tenofovir Disoproxil Fumarate

Tenofovir Disoproxil Fumarate

Tenofovir Disoproxil Fumarate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Laurus Labs Limited. The primary component is Tenofovir Disoproxil Fumarate.

Product ID42385-901_758c6876-348f-4c8a-a814-e811621ebd18
NDC42385-901
Product TypeHuman Prescription Drug
Proprietary NameTenofovir Disoproxil Fumarate
Generic NameTenofovir Disoproxil Fumarate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-02-26
Marketing CategoryANDA / ANDA
Application NumberANDA209550
Labeler NameLaurus Labs Limited
Substance NameTENOFOVIR DISOPROXIL FUMARATE
Active Ingredient Strength300 mg/1
Pharm ClassesHepatitis 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 Through2019-12-31

Packaging

NDC 42385-901-03

30 TABLET, FILM COATED in 1 BOTTLE (42385-901-03)
Marketing Start Date2018-02-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42385-901-50 [42385090150]

Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209550
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-26
Inactivation Date2020-01-31

NDC 42385-901-03 [42385090103]

Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209550
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-26
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TENOFOVIR DISOPROXIL FUMARATE300 mg/1

OpenFDA Data

SPL SET ID:758c6876-348f-4c8a-a814-e811621ebd18
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349251
    • UPC Code
  • 0342385901030
  • 0342385901504

    • 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

    42385090103 TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Tenofovir Disoproxil Fumarate" or generic name "Tenofovir Disoproxil Fumarate"

    NDCBrand NameGeneric Name
    0093-7104Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    16714-820Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    31722-535Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    42291-800Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    42385-901Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    50268-758TENOFOVIR DISOPROXIL FUMARATEtenofovir disoproxil fumarate
    53808-1128TENOFOVIR DISOPROXIL FUMARATEtenofovir disoproxil fumarate
    60505-4666Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    60687-366Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    62135-466TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE Tablets
    64380-714TENOFOVIR DISOPROXIL FUMARATEtenofovir disoproxil fumarate
    65862-421Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    65862-818Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    69025-101tenofovir disoproxil fumaratetenofovir disoproxil fumarate
    69025-100tenofovir disoproxil fumaratetenofovir disoproxil fumarate
    69025-102tenofovir disoproxil fumaratetenofovir disoproxil fumarate
    69025-103tenofovir disoproxil fumaratetenofovir disoproxil fumarate
    69097-533Tenofovir disoproxil fumarateTenofovir disoproxil fumarate
    70518-0918Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    70518-1002TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE
    65862-819Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    65862-820Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    70518-2151Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    69076-105Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    67184-0521Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    67184-0519Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    67184-0520Tenofovir Disoproxil FumarateTenofovir Disoproxil Fumarate
    50090-0754VireadTENOFOVIR DISOPROXIL FUMARATE
    53808-0810Vireadtenofovir disoproxil fumarate
    61958-0401VireadTENOFOVIR DISOPROXIL FUMARATE
    61958-0403VireadTENOFOVIR DISOPROXIL FUMARATE
    61958-0404VireadTENOFOVIR DISOPROXIL FUMARATE
    61958-0405VireadTENOFOVIR DISOPROXIL FUMARATE
    61958-0406VireadTENOFOVIR DISOPROXIL FUMARATE
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.