Linezolid
These highlights do not include all the information needed to use LINEZOLID INJECTION safely and effectively. See full prescribing information for LINEZOLID INJECTION. LINEZOLID injection for intravenous useInitial U.S. Approval: 2000
Approved
Approval ID
a287cdf4-47a8-459f-8890-86181af5e836
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2023
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Linezolid
PRODUCT DETAILS
NDC Product Code0781-3433
Application NumberANDA200904
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateAugust 3, 2023
Generic NameLinezolid
INGREDIENTS (6)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
LINEZOLIDActive
Quantity: 600 mg in 300 mL
Code: ISQ9I6J12J
Classification: ACTIB
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Linezolid
PRODUCT DETAILS
NDC Product Code0781-3431
Application NumberANDA200904
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateAugust 3, 2023
Generic NameLinezolid
INGREDIENTS (6)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LINEZOLIDActive
Quantity: 200 mg in 100 mL
Code: ISQ9I6J12J
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT