NDC 63010-010

VIRACEPT

Nelfinavir Mesylate

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

Product ID63010-010_03efb824-da3b-4490-b2cc-64d349c9d264
NDC63010-010
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 NameAGOURON
Substance NameNELFINAVIR MESYLATE
Active Ingredient Strength250 mg/1
Pharm ClassesCytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63010-010-30

300 TABLET, FILM COATED in 1 BOTTLE (63010-010-30)
Marketing Start Date1997-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63010-010-30 [63010001030]

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

Drug Details

Active Ingredients

IngredientStrength
NELFINAVIR MESYLATE250 mg/1

OpenFDA Data

SPL SET ID:e72c2bc6-9462-4a2e-8e1d-b97592376cbd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 212118
  • 542370
  • 311924
  • 403978
  • Pharmacological Class

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