NDC 70518-2151

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 Remedyrepack Inc.. The primary component is Tenofovir Disoproxil Fumarate.

Product ID70518-2151_8c420a34-8a0a-5b85-e053-2995a90a70cb
NDC70518-2151
Product TypeHuman Prescription Drug
Proprietary NameTenofovir Disoproxil Fumarate
Generic NameTenofovir Disoproxil Fumarate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-06-24
Marketing CategoryANDA / ANDA
Application NumberANDA090636
Labeler NameREMEDYREPACK INC.
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 Through2020-12-31

Packaging

NDC 70518-2151-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2151-0)
Marketing Start Date2019-06-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2151-1 [70518215101]

Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-30

NDC 70518-2151-0 [70518215100]

Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090636
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-24

Drug Details

Active Ingredients

IngredientStrength
TENOFOVIR DISOPROXIL FUMARATE300 mg/1

OpenFDA Data

SPL SET ID:a916ccbf-b558-4fe1-b513-537efaa3e6c0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349251
  • 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.