NDC 52959-289

VIRACEPT

Nelfinavir Mesylate

VIRACEPT is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Nelfinavir Mesylate.

Product ID52959-289_a0862d45-3327-433a-9d0d-2928a4327527
NDC52959-289
Product TypeHuman Prescription Drug
Proprietary NameVIRACEPT
Generic NameNelfinavir Mesylate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1997-03-14
Marketing CategoryNDA / NDA
Application NumberNDA020779
Labeler NameH.J. Harkins Company, Inc.
Substance NameNELFINAVIR MESYLATE
Active Ingredient Strength250 mg/1
Pharm ClassesHIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 52959-289-06

6 TABLET, FILM COATED in 1 BOTTLE (52959-289-06)
Marketing Start Date1997-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-289-30 [52959028930]

VIRACEPT TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020779
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-03-14
Inactivation Date2019-11-13

NDC 52959-289-06 [52959028906]

VIRACEPT TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020779
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-03-14
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
NELFINAVIR MESYLATE250 mg/1

OpenFDA Data

SPL SET ID:303c9bc8-eaff-4a65-9c60-7de6bddec348
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 212118
  • 311924
  • Pharmacological Class

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

    NDC Crossover Matching brand name "VIRACEPT" or generic name "Nelfinavir Mesylate"

    NDCBrand NameGeneric Name
    52959-289VIRACEPTnelfinavir mesylate
    53808-0809ViraceptNELFINAVIR MESYLATE
    55289-477VIRACEPTnelfinavir mesylate
    63010-010VIRACEPTnelfinavir mesylate
    63010-027VIRACEPTnelfinavir mesylate

    Trademark Results [VIRACEPT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VIRACEPT
    VIRACEPT
    74683161 2007831 Live/Registered
    AGOURUN PHARMACEUTICALS, LLC
    1995-06-01

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