Invirase

Product NDC
53808-0674
11-digit product format
538080674
Labeler code
53808
Product ID
53808-0674_e981c067-b7f7-440b-a4d3-1cd79038af4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
saquinavir mesylate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA021785
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
SAQUINAVIR MESYLATE
Active strength
500 mg/1
Pharmacologic classes
HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a7a4ac4e-c54f-b757-933b-f6abe06b7943Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0674-12020-01-31C16284748780-19d75b9cf-f521-f424-e053-dadaa90a57ceINVIRASE ® (saquinavir mesylate) CAPSULES and TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0674-1Invirase30 in 1 BLISTER PACKTABLET, FILM COATED303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SAQUINAVIR MESYLATEACTIVE INGREDIENTUHB9Z3841AINVIRASE (SAQUINAVIR MESYLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
saquinavirACTIVE MOIETYL3JE09KZ2FINVIRASE (SAQUINAVIR MESYLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48INVIRASE (SAQUINAVIR MESYLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675INVIRASE (SAQUINAVIR MESYLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOINVIRASE (SAQUINAVIR MESYLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GINVIRASE (SAQUINAVIR MESYLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INVIRASE (SAQUINAVIR MESYLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XINVIRASE (SAQUINAVIR MESYLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
TALCINACTIVE INGREDIENT7SEV7J4R1UINVIRASE (SAQUINAVIR MESYLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINVIRASE (SAQUINAVIR MESYLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
TRIACETININACTIVE INGREDIENTXHX3C3X673INVIRASE (SAQUINAVIR MESYLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0674INVIRASE (SAQUINAVIR MESYLATE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3Legacy NDC, 1 package rows20100922_b8b53129-06ab-4143-b9b7-7675e49a52ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859865Invirase 500 MG Oral TabletPSNb8b53129-06ab-4143-b9b7-7675e49a52ef3
859863saquinavir mesylate 500 MG Oral TabletPSNb8b53129-06ab-4143-b9b7-7675e49a52ef3
859865saquinavir mesylate 500 MG Oral Tablet [Invirase]SBDb8b53129-06ab-4143-b9b7-7675e49a52ef3
859863saquinavir mesylate 500 MG Oral TabletSCDb8b53129-06ab-4143-b9b7-7675e49a52ef3
859865Invirase 500 MG Oral TabletSYb8b53129-06ab-4143-b9b7-7675e49a52ef3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0674-15380806740130 in 1 BLISTER PACKHistorical