Rilutek
These highlights do not include all the information needed to use RILUTEK safely and effectively. See full prescribing information for RILUTEK RILUTEK (riluzole) tablets, for oral useInitial U.S. Approval: 1995
Approved
Approval ID
6ddc26d7-a6fe-46dd-8b49-c55aa111f83e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2022
Manufacturers
FDA
Covis Pharma US, Inc
DUNS: 118094829
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 Code70515-700
Application NumberNDA020599
Product Classification
M
Marketing Category
C73594
G
Generic Name
riluzole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2020
FDA Product Classification
INGREDIENTS (9)
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
riluzoleActive
Quantity: 50 mg in 1 1
Code: 7LJ087RS6F
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
polyethylene glycol 6000Inactive
Code: 30IQX730WE
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT