NDC 66298-5137

Zyvox

Linezolid

Zyvox is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Norge As. The primary component is Linezolid.

Product ID66298-5137_74f6ba39-459c-c32b-e053-2991aa0a665c
NDC66298-5137
Product TypeHuman Prescription Drug
Proprietary NameZyvox
Generic NameLinezolid
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-06-04
Marketing CategoryNDA / NDA
Application NumberNDA021131
Labeler NameFresenius Kabi Norge As
Substance NameLINEZOLID
Active Ingredient Strength200 mg/100mL
Pharm ClassesOxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 66298-5137-1

100 mL in 1 BAG (66298-5137-1)
Marketing Start Date2018-06-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66298-5137-1 [66298513701]

Zyvox INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021131
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-04

Drug Details

Active Ingredients

IngredientStrength
LINEZOLID200 mg/100mL

OpenFDA Data

SPL SET ID:ce57225b-4580-442b-8c48-8045297cbb50
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1662278
  • 1662280
  • Pharmacological Class

    • Oxazolidinone Antibacterial [EPC]
    • Oxazolidinones [CS]
    • Oxazolidinone Antibacterial [EPC]
    • Oxazolidinones [CS]

    NDC Crossover Matching brand name "Zyvox" or generic name "Linezolid"

    NDCBrand NameGeneric Name
    0009-4992Zyvoxlinezolid
    0009-5136Zyvoxlinezolid
    0009-5137Zyvoxlinezolid
    0009-5138Zyvoxlinezolid
    0009-5140Zyvoxlinezolid
    21695-399ZyvoxZyvox
    0009-7807ZyvoxZyvox
    55695-009ZyvoxZyvox
    66298-5137ZyvoxZyvox
    66298-5140ZyvoxZyvox
    66298-4992ZyvoxZyvox
    66298-7807ZyvoxZyvox
    70518-1226ZyvoxZyvox

    Trademark Results [Zyvox]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZYVOX
    ZYVOX
    75603340 not registered Dead/Abandoned
    PHARMACIA & UPJOHN CARIBE INC
    1998-12-10
    ZYVOX
    ZYVOX
    75603339 not registered Dead/Abandoned
    PHARMACIA & UPJOHN CARIBE INC
    1998-12-10
    ZYVOX
    ZYVOX
    75603338 not registered Dead/Abandoned
    PHARMACIA & UPJOHN CARIBE INC
    1998-12-10
    ZYVOX
    ZYVOX
    75603337 2959967 Live/Registered
    C.P. PHARMACEUTICALS INTERNATIONAL C.V.
    1998-12-10
    ZYVOX
    ZYVOX
    75589931 not registered Dead/Abandoned
    PHARMACIA & UPJOHN COMPANY
    1998-11-17

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