Xeloda

Product NDC
0004-1100
11-digit product format
000041100
Labeler code
0004
Product ID
0004-1100_7905031f-2a24-4618-bd70-cf4343ad0a0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
capecitabine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Genentech, Inc.
Application
NDA020896
Marketing category
NDA
Marketing start
1998-04-30
Marketing end
0000-00-00
Substance
CAPECITABINE
Active strength
150 mg/1
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a5eae620-c3a7-41bb-55a8-fce9c3eb9864Product name920180820

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0004-1100-20EA - Each0004-11009df16795-316e-47fa-9012-79b220cff69012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
capecitabineACTIVE INGREDIENT6804DJ8Z9UXELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.]12
capecitabineACTIVE MOIETY6804DJ8Z9UXELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.]12
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKXELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.]12
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UXELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.]12
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.]12
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.]12
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTXELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.]12
hypromellosesINACTIVE INGREDIENT3NXW29V3WOXELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.]12
magnesium stearateINACTIVE INGREDIENT70097M6I30XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.]12
talcINACTIVE INGREDIENT7SEV7J4R1UXELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.]12
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPXELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.]12
waterINACTIVE INGREDIENT059QF0KO0RXELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.]12
capecitabineACTIVE INGREDIENT6804DJ8Z9UXELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
capecitabineACTIVE MOIETY6804DJ8Z9UXELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UXELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTXELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
Hypromellose 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
talcINACTIVE INGREDIENT7SEV7J4R1UXELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPXELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
waterINACTIVE INGREDIENT059QF0KO0RXELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0004-1100XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.]29Legacy NDC20241124_a1de8bba-3b1d-4c9d-ab8a-32d2c05e67c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200327capecitabine 150 MG Oral TabletPSN6b76b5bb-1d69-43f9-99c6-f39a0b6d8a263
200328capecitabine 500 MG Oral TabletPSN6b76b5bb-1d69-43f9-99c6-f39a0b6d8a263
213292Xeloda 150 MG Oral TabletPSN6b76b5bb-1d69-43f9-99c6-f39a0b6d8a263
213293Xeloda 500 MG Oral TabletPSN6b76b5bb-1d69-43f9-99c6-f39a0b6d8a263
213292capecitabine 150 MG Oral Tablet [Xeloda]SBD6b76b5bb-1d69-43f9-99c6-f39a0b6d8a263
213293capecitabine 500 MG Oral Tablet [Xeloda]SBD6b76b5bb-1d69-43f9-99c6-f39a0b6d8a263
200327capecitabine 150 MG Oral TabletSCD6b76b5bb-1d69-43f9-99c6-f39a0b6d8a263
200328capecitabine 500 MG Oral TabletSCD6b76b5bb-1d69-43f9-99c6-f39a0b6d8a263
213292Xeloda 150 MG Oral TabletSY6b76b5bb-1d69-43f9-99c6-f39a0b6d8a263
213293Xeloda 500 MG Oral TabletSY6b76b5bb-1d69-43f9-99c6-f39a0b6d8a263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0004-1100-200000411002060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-1100-20) 1998-04-300000-00-00NoNoCurrent