Linezolid
These highlights do not include all the information needed to use LINEZOLID TABLETS safely and effectively. See full prescribing information for LINEZOLID TABLETS. LINEZOLID tablets, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
90bec4b1-d5c3-4880-8027-788b72d8e1fc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Linezolid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-777
Application NumberANDA204536
Product Classification
M
Marketing Category
C73584
G
Generic Name
Linezolid
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (11)
LINEZOLIDActive
Quantity: 600 mg in 1 1
Code: ISQ9I6J12J
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT