NDC 70518-1483

PREZISTA

Darunavir

PREZISTA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Darunavir Ethanolate.

Product ID70518-1483_7872ed63-fc6c-7631-e053-2991aa0a4848
NDC70518-1483
Product TypeHuman Prescription Drug
Proprietary NamePREZISTA
Generic NameDarunavir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-10-06
Marketing CategoryNDA / NDA
Application NumberNDA021976
Labeler NameREMEDYREPACK INC.
Substance NameDARUNAVIR ETHANOLATE
Active Ingredient Strength800 mg/1
Pharm ClassesHIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1483-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1483-0)
Marketing Start Date2018-10-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1483-0 [70518148300]

PREZISTA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021976
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-06

Drug Details

Active Ingredients

IngredientStrength
DARUNAVIR ETHANOLATE800 mg/1

OpenFDA Data

SPL SET ID:812ddacc-9562-4dde-8d52-d06ae06e07e9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1359271
  • 1359269

    • Pharmacological Class

    • HIV Protease Inhibitors [MoA]
    • Protease Inhibitor [EPC]
    • Cytochrome P450 3A Inhibitors [MoA]
    • Cytochrome P450 2D6 Inhibitors [MoA]

    NDC Crossover Matching brand name "PREZISTA" or generic name "Darunavir"

    NDCBrand NameGeneric Name
    50090-1327PREZISTAdarunavir
    50090-1491PREZISTAdarunavir
    53808-0672PREZISTAdarunavir ethanolate
    53808-0773PREZISTAdarunavir ethanolate
    59676-562PREZISTAdarunavir
    59676-563PREZISTAdarunavir
    59676-564PREZISTAdarunavir
    59676-565PREZISTAdarunavir
    70518-0689PREZISTAPREZISTA
    70518-1483PREZISTAPREZISTA
    59676-566PREZISTAPREZISTA

    Trademark Results [PREZISTA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PREZISTA
    PREZISTA
    78762650 3236346 Live/Registered
    JANSSEN SCIENCES IRELAND UNLIMITED COMPANY
    2005-11-29
    PREZISTA
    PREZISTA
    77239629 not registered Dead/Abandoned
    Tibotec Pharmaceuticals Ltd.
    2007-07-26
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.