Zyvox
ZYVOX (linezolid) injection(linezolid) tablets(linezolid) for oral suspension
Approved
Approval ID
50630775-7f76-413e-9278-ba298dd7f187
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-399
Application NumberNDA021130
Product Classification
M
Marketing Category
C73594
G
Generic Name
linezolid
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2010
FDA Product Classification
INGREDIENTS (9)
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
linezolidActive
Quantity: 600 mg in 1 1
Code: ISQ9I6J12J
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT