CAPECITABINE TABLETS, 150 MG- capecitabine tablets, 150 mg tablet 
CAPECITABINE TABLETS, 500 MG- capecitabine tablets, 500 mg tablet 
Prodigy Innovation, LLC.

----------

Capecitabine Tablets, USP 150 mg and 500 mg

Capecitabine TabletsCapecitabine Tablets

CAPECITABINE TABLETS, 150 MG 
capecitabine tablets, 150 mg tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70297-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPECITABINE (UNII: 6804DJ8Z9U) (CAPECITABINE - UNII:6804DJ8Z9U) CAPECITABINE150 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColororangeScorescore with uneven pieces
ShapeCAPSULESize16mm
FlavorImprint Code PI;150
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70297-003-0225000 in 1 BAG; Type 0: Not a Combination Product04/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only04/22/2019
CAPECITABINE TABLETS, 500 MG 
capecitabine tablets, 500 mg tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70297-004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPECITABINE (UNII: 6804DJ8Z9U) (CAPECITABINE - UNII:6804DJ8Z9U) CAPECITABINE500 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeCAPSULESize11mm
FlavorORANGEImprint Code PI;500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70297-004-0225000 in 1 BAG; Type 0: Not a Combination Product04/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only04/22/2019
Labeler - Prodigy Innovation, LLC. (080058064)

Revised: 4/2019
Document Id: 87173e7c-6e2a-2e85-e053-2a91aa0ae4ae
Set id: 87173e7c-6e29-2e85-e053-2a91aa0ae4ae
Version: 1
Effective Time: 20190421
 
Prodigy Innovation, LLC.