VIRACEPT
These highlights do not include all the information needed to use VIRACEPT safely and effectively. See full prescribing information for VIRACEPT. VIRACEPT (nelfinavir mesylate) Tablets, for oral use VIRACEPT(nelfinavir mesylate) Oral Powder, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
e72c2bc6-9462-4a2e-8e1d-b97592376cbd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 19, 2023
Manufacturers
FDA
AGOURON
DUNS: 145772760
Products 2
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 Code63010-010
Application NumberNDA020779
Product Classification
M
Marketing Category
C73594
G
Generic Name
nelfinavir mesylate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2021
FDA Product Classification
INGREDIENTS (7)
NELFINAVIR MESYLATEActive
Quantity: 250 mg in 1 1
Code: 98D603VP8V
Classification: ACTIM
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CALCIUM SILICATEInactive
Code: S4255P4G5M
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
nelfinavir mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63010-027
Application NumberNDA021503
Product Classification
M
Marketing Category
C73594
G
Generic Name
nelfinavir mesylate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2021
FDA Product Classification
INGREDIENTS (7)
NELFINAVIR MESYLATEActive
Quantity: 625 mg in 1 1
Code: 98D603VP8V
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
CALCIUM SILICATEInactive
Code: S4255P4G5M
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT