CALQUENCE
These highlights do not include all the information needed to use CALQUENCE safely and effectively. See full prescribing information for CALQUENCE.CALQUENCE (acalabrutinib) tablets, for oral useInitial U.S. Approval: 2017
Approved
Approval ID
b1409184-3267-4d8c-8f17-4e01f69828b1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 4, 2022
Manufacturers
FDA
AstraZeneca Pharmaceuticals LP
DUNS: 054743190
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acalabrutinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-3512
Application NumberNDA216387
Product Classification
M
Marketing Category
C73594
G
Generic Name
acalabrutinib
Product Specifications
Route of AdministrationORAL
Effective DateAugust 4, 2022
FDA Product Classification
INGREDIENTS (13)
ACALABRUTINIBActive
Quantity: 100 mg in 1 1
Code: I42748ELQW
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT