NFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69853-0202
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
betrixaban (UNII: 74RWP7W0J9) (betrixaban - UNII:74RWP7W0J9) betrixaban 40 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
dextrose monohydrate (UNII: LX22YL083G)
croscarmellose sodium (UNII: M28OL1HH48)
magnesium stearate (UNII: 70097M6I30)
FD&C blue no. 1 (UNII: H3R47K3TBD)
ferrosoferric oxide (UNII: XM0M87F357)
titanium dioxide (UNII: 15FIX9V2JP)
gelatin, unspecified (UNII: 2G86QN327L)
PRODUCT CHARACTERISTICS
Color BLUE (light blue) , GRAY (light gray) Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code 40;PTLA
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:69853-0202-1 1 in 1 CARTON 07/07/2017
1 100 in 1 BOTTLE; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208383 07/07/2017
BEVYXXA
betrixaban capsule, gelatin coated
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69853-0201
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
betrixaban (UNII: 74RWP7W0J9) (betrixaban - UNII:74RWP7W0J9) betrixaban 80 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
dextrose monohydrate (UNII: LX22YL083G)
croscarmellose sodium (UNII: M28OL1HH48)
magnesium stearate (UNII: 70097M6I30)
FD&C blue no. 1 (UNII: H3R47K3TBD)
ferrosoferric oxide (UNII: XM0M87F357)
titanium dioxide (UNII: 15FIX9V2JP)
gelatin, unspecified (UNII: 2G86QN327L)
ferric oxide yellow (UNII: EX438O2MRT)
PRODUCT CHARACTERISTICS
Color BLUE, GRAY (light gray) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code 80;PTLA
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:69853-0201-1 1 in 1 CARTON 07/07/2017
1 100 in 1 BOTTLE; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208383 07/07/2017
LABELER - PORTOLA PHARMACEUTICALS, INC. (142296016)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Patheon, Inc. 240769596 MANUFACTURE(69853-0202, 69853-0201) , ANALYSIS(69853-0202, 69853-0201)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Packaging Coordinators, Inc. 053217022 LABEL(69853-0202, 69853-0201) , PACK(69853-0202, 69853-0201) |
