Fingolimod
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2010
Approved
Approval ID
3f9827b7-f7b0-4c5a-a53d-b08641d45beb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2023
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fingolimod
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-4525
Application NumberANDA208005
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fingolimod
Product Specifications
Route of AdministrationORAL
Effective DateJuly 15, 2021
FDA Product Classification
INGREDIENTS (15)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FINGOLIMOD HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: G926EC510T
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT