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 use Initial U.S. Approval: 2000
Approved
Approval ID
870c9600-04d5-4b44-a5b5-02252a310f22
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 8, 2023
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 2
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 Code57664-682
Application NumberANDA207354
Product Classification
M
Marketing Category
C73584
G
Generic Name
linezolid
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 8, 2023
FDA Product Classification
INGREDIENTS (4)
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
LINEZOLIDActive
Quantity: 200 mg in 100 mL
Code: ISQ9I6J12J
Classification: ACTIB
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
linezolid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57664-683
Application NumberANDA207354
Product Classification
M
Marketing Category
C73584
G
Generic Name
linezolid
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 8, 2023
FDA Product Classification
INGREDIENTS (4)
LINEZOLIDActive
Quantity: 600 mg in 300 mL
Code: ISQ9I6J12J
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT