Rubraca
These highlights do not include all the information needed to use RUBRACA safely and effectively. See full prescribing information for RUBRACA. RUBRACA (rucaparib) tablets, for oral use Initial U.S. Approval: 2016
Approved
Approval ID
0295d202-1cfe-7659-e063-6294a90a476e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2023
Manufacturers
FDA
pharmaand GmbH
DUNS: 300539513
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
rucaparib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82154-0785
Application NumberNDA209115
Product Classification
M
Marketing Category
C73594
G
Generic Name
rucaparib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (10)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
RUCAPARIB CAMSYLATEActive
Quantity: 300 mg in 1 1
Code: 41AX9SJ8KO
Classification: ACTIM
rucaparib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82154-0783
Application NumberNDA209115
Product Classification
M
Marketing Category
C73594
G
Generic Name
rucaparib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
RUCAPARIB CAMSYLATEActive
Quantity: 200 mg in 1 1
Code: 41AX9SJ8KO
Classification: ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
rucaparib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82154-0784
Application NumberNDA209115
Product Classification
M
Marketing Category
C73594
G
Generic Name
rucaparib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (9)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
RUCAPARIB CAMSYLATEActive
Quantity: 250 mg in 1 1
Code: 41AX9SJ8KO
Classification: ACTIM
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT