Riluzole
These highlights do not include all the information needed to use RILUZOLE TABLETS safely and effectively. See full prescribing information for RILUZOLE TABLETS. RILUZOLE tablets, for oral useInitial U.S. Approval: 1995
Approved
Approval ID
97457622-5727-4b07-9e72-edd784b2d76d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2020
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.
riluzole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-4145
Application NumberANDA203042
Product Classification
M
Marketing Category
C73584
G
Generic Name
riluzole
Product Specifications
Route of AdministrationORAL
Effective DateMay 11, 2016
FDA Product Classification
INGREDIENTS (9)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
RILUZOLEActive
Quantity: 50 mg in 1 1
Code: 7LJ087RS6F
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT