NDC 59676-564

PREZISTA

Darunavir

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

Product ID59676-564_04a6e608-8107-11eb-8ef7-26defb2ca371
NDC59676-564
Product TypeHuman Prescription Drug
Proprietary NamePREZISTA
Generic NameDarunavir
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-04-27
Marketing CategoryNDA / NDA
Application NumberNDA021976
Labeler NameJanssen Products LP
Substance NameDARUNAVIR ETHANOLATE
Active Ingredient Strength150 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 Through2022-12-31

Packaging

NDC 59676-564-01

240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-564-01)
Marketing Start Date2009-04-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59676-564-01 [59676056401]

PREZISTA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021976
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-04-27

Drug Details

Active Ingredients

IngredientStrength
DARUNAVIR ETHANOLATE150 mg/1

OpenFDA Data

SPL SET ID:814301f9-c990-46a5-b481-2879a521a16f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1359271
  • 831868
  • 1236628
  • 1236632
  • 831870
  • 794610
  • 850455
  • 850457
  • 1359269
  • 670026
  • 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

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