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, tablets and oral suspension Initial U.S. Approval: 2000
Approved
Approval ID
ce57225b-4580-442b-8c48-8045297cbb50
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 Code66298-5137
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
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