VIRACEPT
VIRACEPT (nelfinavir mesylate) TABLETS and ORAL POWDER
Approved
Approval ID
303c9bc8-eaff-4a65-9c60-7de6bddec348
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-289
Application NumberNDA020779
Product Classification
M
Marketing Category
C73594
G
Generic Name
nelfinavir mesylate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 22, 2012
FDA Product Classification
INGREDIENTS (7)
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
calcium silicateInactive
Code: S4255P4G5M
Classification: IACT
nelfinavir mesylateActive
Quantity: 250 mg in 1 1
Code: 98D603VP8V
Classification: ACTIM
crospovidoneInactive
Code: 68401960MK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
FD&C blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT