Cibinqo
These highlights do not include all the information needed to use CIBINQO safely and effectively. See full prescribing information for CIBINQO. CIBINQO (abrocitinib) tablets, for oral use Initial U.S. Approval: 2022
Approved
Approval ID
3f6d6fcd-e9f9-42c8-bfa2-bb2cfc9ed258
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
abrocitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0435
Application NumberNDA213871
Product Classification
M
Marketing Category
C73594
G
Generic Name
abrocitinib
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 13, 2023
FDA Product Classification
INGREDIENTS (11)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ABROCITINIBActive
Quantity: 200 mg in 1 1
Code: 73SM5SF3OR
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
abrocitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0335
Application NumberNDA213871
Product Classification
M
Marketing Category
C73594
G
Generic Name
abrocitinib
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 13, 2023
FDA Product Classification
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ABROCITINIBActive
Quantity: 100 mg in 1 1
Code: 73SM5SF3OR
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
abrocitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0235
Application NumberNDA213871
Product Classification
M
Marketing Category
C73594
G
Generic Name
abrocitinib
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 13, 2023
FDA Product Classification
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
ABROCITINIBActive
Quantity: 50 mg in 1 1
Code: 73SM5SF3OR
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT