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
NDC Product Code50881-007
Application NumberNDA215309
Marketing CategoryC73594
Route of AdministrationTOPICAL
Effective DateSeptember 20, 2023
Generic Nameruxolitinib
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