Xeloda

Product NDC
53808-0411
11-digit product format
538080411
Labeler code
53808
Product ID
53808-0411_15601703-7442-48f3-89f4-44fef66b7514
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
capecitabine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA020896
Marketing category
NDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
CAPECITABINE
Active strength
500 mg/1
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
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
a5eae620-c3a7-41bb-55a8-fce9c3eb9864Product name920180820

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0411-12019-10-21C16284748780-1956f9ecf-d1d3-621f-e053-dbdaa90a74adXELODA ® (capecitabine) TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0411-1Xeloda30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPECITABINEACTIVE INGREDIENT6804DJ8Z9UXELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
capecitabineACTIVE MOIETY6804DJ8Z9UXELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKXELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UXELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTXELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOXELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2208 (15000 CPS)INACTIVE INGREDIENTZ78RG6M2N2XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UXELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPXELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
WATERINACTIVE INGREDIENT059QF0KO0RXELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0411XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_a732b303-9bbd-42ba-a7c5-61c21629ba93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200328capecitabine 500 MG Oral TabletPSNa732b303-9bbd-42ba-a7c5-61c21629ba931
213293Xeloda 500 MG Oral TabletPSNa732b303-9bbd-42ba-a7c5-61c21629ba931
213293capecitabine 500 MG Oral Tablet [Xeloda]SBDa732b303-9bbd-42ba-a7c5-61c21629ba931
200328capecitabine 500 MG Oral TabletSCDa732b303-9bbd-42ba-a7c5-61c21629ba931
213293Xeloda 500 MG Oral TabletSYa732b303-9bbd-42ba-a7c5-61c21629ba931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0411-15380804110130 in 1 BLISTER PACKHistorical