Eucrisa
These highlights do not include all the information needed to use EUCRISA safely and effectively. See full prescribing information for EUCRISA. EUCRISA (crisaborole) ointment, for topical useInitial U.S. Approval: 2016
Approved
Approval ID
609b77de-1ca3-4783-b8f5-01a9c0f1d77d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2024
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
crisaborole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55724-211
Application NumberNDA207695
Product Classification
M
Marketing Category
C73594
G
Generic Name
crisaborole
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 10, 2020
FDA Product Classification
INGREDIENTS (7)
CRISABOROLEActive
Quantity: 20 mg in 1 g
Code: Q2R47HGR7P
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT