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
dd432c13-389e-46b3-8891-0cf1a58800ff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 9, 2022
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
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 Code67877-286
Application NumberANDA204048
Product Classification
M
Marketing Category
C73584
G
Generic Name
Riluzole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2021
FDA Product Classification
INGREDIENTS (9)
RILUZOLEActive
Quantity: 50 mg in 1 1
Code: 7LJ087RS6F
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT