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
d412a0cd-92ba-4a9c-8e99-f042fce698dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-324
Application NumberANDA205154
Product Classification
M
Marketing Category
C73584
G
Generic Name
linezolid
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (4)
LINEZOLIDActive
Quantity: 200 mg in 100 mL
Code: ISQ9I6J12J
Classification: ACTIB
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
linezolid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67457-843
Application NumberANDA205154
Product Classification
M
Marketing Category
C73584
G
Generic Name
linezolid
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (4)
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
LINEZOLIDActive
Quantity: 600 mg in 300 mL
Code: ISQ9I6J12J
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT