Leflunomide
These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. LEFLUNOMIDE tablets, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
acf3efe4-0d70-4718-9c50-789d69ab215d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 3, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Leflunomide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-2256
Application NumberANDA213652
Product Classification
M
Marketing Category
C73584
G
Generic Name
Leflunomide
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2021
FDA Product Classification
INGREDIENTS (13)
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LEFLUNOMIDEActive
Quantity: 20 mg in 1 1
Code: G162GK9U4W
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT