ol, and talc. The blue film coating contains brilliant blue aluminum lake and indigo carmine aluminum lake. The yellow film coating contains yellow iron oxide.
Distributed by: Clovis Oncology, Inc. Boulder, Colorado 80301
For more information, go to www.Rubraca.com or call 1-844-258-7662.
PRINCIPAL DISPLAY PANEL
NDC 69660-201-91
Rubraca (rucaparib) tablets
200 mg
60 tablets
Each tablet contains 344 mg rucaparib camsylate equivalent to 200 mg rucaparib
Rx only
Keep out of reach of children
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PRINCIPAL DISPLAY PANEL
NDC 69660-202-91
Rubraca (rucaparib) tablets
250 mg
60 tablets
Each tablet contains 430 mg rucaparib camsylate equivalent to 250 mg rucaparib
Rx only
Keep out of reach of children
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PRINCIPAL DISPLAY PANEL
NDC 69660-203-91
Rubraca (rucaparib) tablets
300 mg
60 tablets
Each tablet contains 516 mg rucaparib camsylate equivalent to 300 mg rucaparib
Rx only
Keep out of reach of children
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INGREDIENTS AND APPEARANCE
RUBRACA
rucaparib tablet, film coated
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69660-201
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
rucaparib camsylate (UNII: 41AX9SJ8KO) (rucaparib - UNII:8237F3U7EH) rucaparib 200 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
cellulose, microcrystalline (UNII: OP1R32D61U)
sodium starch glycolate type a potato (UNII: 5856J3G2A2)
silicon dioxide (UNII: ETJ7Z6XBU4)
magnesium stearate (UNII: 70097M6I30)
polyvinyl alcohol, unspecified (UNII: 532B59J990)
titanium dioxide (UNII: 15FIX9V2JP)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
talc (UNII: 7SEV7J4R1U)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C Blue No. 2 (UNII: L06K8R7DQK)
PRODUCT CHARACTERISTICS
Color blue (BLUE) Score no score
Shape ROUND (ROUND) Size 11mm
Flavor Imprint Code C2
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:69660-201-91 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2016
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209115 12/19/2016
RUBRACA
rucaparib tablet, film coated
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69660-203
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
rucaparib camsylate (UNII: 41AX9SJ8KO) (rucaparib - UNII:8237F3U7EH) rucaparib 300 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
cellulose, microcrystalline (UNII: OP1R32D61U)
sodium starch glycolate type a potato (UNII: 5856J3G2A2)
silicon dioxide (UNII: ETJ7Z6XBU4)
magnesium stearate (UNII: 70097M6I30)
polyvinyl alcohol, unspecified (UNII: 532B59J990)
titanium dioxide (UNII: 15FIX9V2JP |
