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 Initial U.S. Approval: 2000
Approved
Approval ID
217f3ee2-2534-4c32-8e9d-09b6d65df4af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2017
Manufacturers
FDA
Fresenius Kabi Norge AS
DUNS: 731170932
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 Code66298-7131
Application NumberANDA204764
Product Classification
M
Marketing Category
C73584
G
Generic Name
LINEZOLID
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 2, 2017
FDA Product Classification
INGREDIENTS (6)
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
LINEZOLIDActive
Quantity: 2 mg in 1 mL
Code: ISQ9I6J12J
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT