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 useInitial U.S. Approval:2000
Approved
Approval ID
13990ee8-8fbe-402d-8aba-cba78964fd32
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2019
Manufacturers
FDA
Novel Laboratories, Inc.
DUNS: 793518643
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 Code40032-022
Application NumberANDA207526
Product Classification
M
Marketing Category
C73584
G
Generic Name
Linezolid
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2019
FDA Product Classification
INGREDIENTS (10)
LINEZOLIDActive
Quantity: 600 mg in 1 1
Code: ISQ9I6J12J
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
POLYETHYLENE GLYCOL 1000Inactive
Code: U076Q6Q621
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT