OPZELURA
These highlights do not include all the information needed to use OPZELURA cream safely and effectively. OPZELURA cream. OPZELURA (ruxolitinib) cream, for topical use Initial U.S. Approval: 2011
Approved
Approval ID
24da5509-6631-4795-9d42-273faecd08e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 20, 2023
Manufacturers
FDA
Incyte Corporation
DUNS: 556967347
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ruxolitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50881-007
Application NumberNDA215309
Product Classification
M
Marketing Category
C73594
G
Generic Name
ruxolitinib
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 20, 2023
FDA Product Classification
INGREDIENTS (17)
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL 200Inactive
Code: R95B8J264J
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
DIMETHICONE 350Inactive
Code: 2Y53S6ATLU
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
RUXOLITINIB PHOSPHATEActive
Quantity: 15 mg in 1 g
Code: 436LRU32H5
Classification: ACTIM
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
WHITE PETROLATUMInactive
Code: B6E5W8RQJ4
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT