VIRACEPT

Product NDC
63010-010
11-digit product format
630100010
Labeler code
63010
Product ID
63010-010_4af6d4ca-b410-48e3-925e-ce23a14db18a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nelfinavir mesylate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AGOURON
Application
NDA020779
Marketing category
NDA
Marketing start
1997-03-14
Substance
NELFINAVIR MESYLATE
Active strength
250 mg/1
Pharmacologic classes
Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VIRACEPT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NELFINAVIR MESYLATE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98D603VP8V
Rxcui212118, 311924, 403978, 542370

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bbaaa820-0ac4-4c6a-95a8-d040a00e04f6Product name120170614

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63010-010-30VIRACEPT300 in 1 BOTTLETABLET, FILM COATED30035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63010-010-30EA - Each63010-010207fce96-c7d7-49b1-98c0-f880e1ec36ad12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NELFINAVIR MESYLATEACTIVE INGREDIENT98D603VP8VVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON]22
NELFINAVIRACTIVE MOIETYHO3OGH5D7IVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON]22
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON]22
CALCIUM SILICATEINACTIVE INGREDIENTS4255P4G5MVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON]22
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON]22
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON]22
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON]22
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON]22
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON]22
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON]22
POTASSIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTCI71S98N1ZVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON]22
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON]22
SUCROSE PALMITATEINACTIVE INGREDIENT3OSQ643ZK5VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON]22
TRIACETININACTIVE INGREDIENTXHX3C3X673VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON]22
nelfinavir mesylateACTIVE INGREDIENT98D603VP8VVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
nelfinavirACTIVE MOIETYHO3OGH5D7IVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
calcium silicateINACTIVE INGREDIENTS4255P4G5MVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
crospovidoneINACTIVE INGREDIENT68401960MKVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WOVIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3
triacetinINACTIVE INGREDIENTXHX3C3X673VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63010-010VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [AGOURON]34Current NDC, Legacy NDC, 1 package rows20240503_e72c2bc6-9462-4a2e-8e1d-b97592376cbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311924nelfinavir mesylate 250 MG Oral TabletPSNe72c2bc6-9462-4a2e-8e1d-b97592376cbd35
403978nelfinavir mesylate 625 MG Oral TabletPSNe72c2bc6-9462-4a2e-8e1d-b97592376cbd35
212118Viracept 250 MG Oral TabletPSNe72c2bc6-9462-4a2e-8e1d-b97592376cbd35
542370Viracept 625 MG Oral TabletPSNe72c2bc6-9462-4a2e-8e1d-b97592376cbd35
212118nelfinavir 250 MG Oral Tablet [Viracept]SBDe72c2bc6-9462-4a2e-8e1d-b97592376cbd35
542370nelfinavir 625 MG Oral Tablet [Viracept]SBDe72c2bc6-9462-4a2e-8e1d-b97592376cbd35
311924nelfinavir 250 MG Oral TabletSCDe72c2bc6-9462-4a2e-8e1d-b97592376cbd35
403978nelfinavir 625 MG Oral TabletSCDe72c2bc6-9462-4a2e-8e1d-b97592376cbd35
212118Viracept 250 MG Oral TabletSYe72c2bc6-9462-4a2e-8e1d-b97592376cbd35
542370Viracept 625 MG Oral TabletSYe72c2bc6-9462-4a2e-8e1d-b97592376cbd35
311924nelfinavir mesylate 250 MG Oral TabletPSN303c9bc8-eaff-4a65-9c60-7de6bddec3483
212118Viracept 250 MG Oral TabletPSN303c9bc8-eaff-4a65-9c60-7de6bddec3483
212118nelfinavir 250 MG Oral Tablet [Viracept]SBD303c9bc8-eaff-4a65-9c60-7de6bddec3483
311924nelfinavir 250 MG Oral TabletSCD303c9bc8-eaff-4a65-9c60-7de6bddec3483
212118Viracept 250 MG Oral TabletSY303c9bc8-eaff-4a65-9c60-7de6bddec3483

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63010-010-3063010001030300 TABLET, FILM COATED in 1 BOTTLE (63010-010-30) 1997-03-140000-00-00NoNoCurrent