Viracept
VIRACEPT (nelfinavir mesylate) TABLETS and ORAL POWDER
Approved
Approval ID
9b370904-d2cd-4585-bc48-a8110621c8bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 13, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NELFINAVIR MESYLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0809
Application NumberNDA021503
Product Classification
M
Marketing Category
C73594
G
Generic Name
NELFINAVIR MESYLATE
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2010
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
NELFINAVIR MESYLATEActive
Quantity: 625 mg in 1 1
Code: 98D603VP8V
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CALCIUM SILICATEInactive
Code: S4255P4G5M
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT