Zyvox
These highlights do not include all the information needed to use ZYVOX safely and effectively. See full prescribing information for ZYVOX. ZYVOX (linezolid) injection Initial U.S. Approval: 2000
Approved
Approval ID
b0c75e79-bf29-4f1d-a45d-ae28398a52d9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 3, 2018
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 Code66298-7807
Application NumberNDA021131
Product Classification
M
Marketing Category
C73594
G
Generic Name
LINEZOLID
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 3, 2018
FDA Product Classification
INGREDIENTS (4)
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
LINEZOLIDActive
Quantity: 600 mg in 300 mL
Code: ISQ9I6J12J
Classification: ACTIB