FANAPT
These highlights do not include all the information needed to use FANAPT safely and effectively. See full prescribing information for FANAPT. FANAPT® (iloperidone) tablets Initial U.S. Approval: 2009
Approved
Approval ID
b414d51b-9e4d-4045-bf29-108be5327e00
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 21, 2017
Manufacturers
FDA
Avera McKennan Hospital
DUNS: 068647668
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Iloperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69189-0597
Application NumberNDA022192
Product Classification
M
Marketing Category
C73594
G
Generic Name
Iloperidone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2017
FDA Product Classification
INGREDIENTS (8)
ILOPERIDONEActive
Quantity: 4 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT