LEXIVA

Product NDC
53808-0281
11-digit product format
538080281
Labeler code
53808
Product ID
53808-0281_cece4944-71c2-4ded-a002-3475b1cae6a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fosamprenavir calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA021548
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
FOSAMPRENAVIR CALCIUM
Active strength
700 mg/1
Pharmacologic classes
Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],P-Glycoprotein Inducers [MoA],HIV Protease Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30518cdc-4e65-0105-bf49-967999bc76dbProduct name320200506

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0281-1LEXIVA30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOSAMPRENAVIR CALCIUMACTIVE INGREDIENTID1GU2627NLEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
AMPRENAVIRACTIVE MOIETY5S0W860XNRLEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOLEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XLEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0281LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100526_009575f9-74e8-4a6d-9fa6-3cae72fd01c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402109fosamprenavir calcium 700 MG Oral TabletPSN009575f9-74e8-4a6d-9fa6-3cae72fd01c31
402110Lexiva 700 MG Oral TabletPSN009575f9-74e8-4a6d-9fa6-3cae72fd01c31
402110fosamprenavir 700 MG Oral Tablet [Lexiva]SBD009575f9-74e8-4a6d-9fa6-3cae72fd01c31
402109fosamprenavir 700 MG Oral TabletSCD009575f9-74e8-4a6d-9fa6-3cae72fd01c31
402109fosamprenavir (as fosamprenavir calcium) 700 MG (amprenavir 600 MG) Oral TabletSY009575f9-74e8-4a6d-9fa6-3cae72fd01c31
402110Lexiva (as fosamprenavir calcium) 700 MG (amprenavir 600 MG) Oral TabletSY009575f9-74e8-4a6d-9fa6-3cae72fd01c31
402110Lexiva 700 MG Oral TabletSY009575f9-74e8-4a6d-9fa6-3cae72fd01c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0281-15380802810130 in 1 BLISTER PACKHistorical