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 use Initial U.S. Approval: 1995
Approved
Approval ID
4c851be4-f0d0-4b24-baf9-427ddfc6f7b0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 16, 2020
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code62756-538
Application NumberANDA091417
Product Classification
M
Marketing Category
C73584
G
Generic Name
Riluzole
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2020
FDA Product Classification
INGREDIENTS (11)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
RILUZOLEActive
Quantity: 50 mg in 1 1
Code: 7LJ087RS6F
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT