TRUQAP
These highlights do not include all the information needed to use TRUQAP safely and effectively. See full prescribing information for TRUQAP. TRUQAP™ (capivasertib) tablets, for oral useInitial U.S. Approval: 2023
Approved
Approval ID
d698c106-2322-401e-b738-cbd83c843ecf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
Manufacturers
FDA
AstraZeneca Pharmaceuticals LP
DUNS: 054743190
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
capivasertib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-9500
Application NumberNDA218197
Product Classification
M
Marketing Category
C73594
G
Generic Name
capivasertib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (15)
CAPIVASERTIBActive
Quantity: 160 mg in 1 1
Code: WFR23M21IE
Classification: ACTIM
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
capivasertib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-9501
Application NumberNDA218197
Product Classification
M
Marketing Category
C73594
G
Generic Name
capivasertib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (15)
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CAPIVASERTIBActive
Quantity: 200 mg in 1 1
Code: WFR23M21IE
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT