CALQUENCE
These highlights do not include all the information needed to use CALQUENCE safely and effectively. See full prescribing information for CALQUENCE.CALQUENCE (acalabrutinib) capsules, for oral useInitial U.S. Approval: 2017
Approved
Approval ID
dd4835ef-e1bc-4997-a399-1ffa2556fbfe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 23, 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 Code0310-0512
Application NumberNDA210259
Product Classification
M
Marketing Category
C73594
G
Generic Name
Acalabrutinib
Product Specifications
Route of AdministrationORAL
Effective DateMarch 23, 2022
FDA Product Classification
INGREDIENTS (10)
ACALABRUTINIBActive
Quantity: 100 mg in 1 1
Code: I42748ELQW
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT