NDC 65862-820

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 Aurobindo Pharma Limited. The primary component is Tenofovir Disoproxil Fumarate.

Product ID65862-820_1b4773e0-2b1e-4b3e-9f42-15ec36fd8c29
NDC65862-820
Product TypeHuman Prescription Drug
Proprietary NameTenofovir Disoproxil Fumarate
Generic NameTenofovir Disoproxil Fumarate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-01-26
Marketing CategoryANDA / ANDA
Application NumberANDA090647
Labeler NameAurobindo Pharma Limited
Substance NameTENOFOVIR DISOPROXIL FUMARATE
Active Ingredient Strength250 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 Through2020-12-31

Packaging

NDC 65862-820-03

3 BLISTER PACK in 1 CARTON (65862-820-03) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2018-01-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-820-10 [65862082010]

Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090647
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-26
Marketing End Date2019-06-26

NDC 65862-820-03 [65862082003]

Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090647
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-26

NDC 65862-820-30 [65862082030]

Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090647
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-26

Drug Details

Active Ingredients

IngredientStrength
TENOFOVIR DISOPROXIL FUMARATE250 mg/1

OpenFDA Data

SPL SET ID:a75c6be8-3719-4bb3-8a9e-06e5254d2a82
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349251
  • 1243324
  • 1243328
  • 1243227
    • UPC Code
  • 0365862820303
  • 0365862819307

    • 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]

    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.