ZEPOSIA
These highlights do not include all the information needed to use ZEPOSIA safely and effectively. See full prescribing information for ZEPOSIA. ZEPOSIA (ozanimod) capsules, for oral use Initial U.S. Approval: 2020
Approved
Approval ID
93ce2fab-edfb-4804-8074-963071de51e4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 10, 2023
Manufacturers
FDA
Celgene Corporation
DUNS: 174201137
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ozanimod hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-890
Application NumberNDA209899
Product Classification
M
Marketing Category
C73594
G
Generic Name
ozanimod hydrochloride
Product Specifications
Effective DateJune 20, 2023
FDA Product Classification
ozanimod hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-810
Application NumberNDA209899
Product Classification
M
Marketing Category
C73594
G
Generic Name
ozanimod hydrochloride
Product Specifications
Effective DateJune 20, 2023
FDA Product Classification
ozanimod hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-820
Application NumberNDA209899
Product Classification
M
Marketing Category
C73594
G
Generic Name
ozanimod hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 20, 2023
FDA Product Classification
INGREDIENTS (5)
OZANIMOD HYDROCHLORIDEActive
Quantity: 0.92 mg in 1 1
Code: 3UPR33JAAM
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT