NDC 0009-5138

Zyvox

Linezolid

Zyvox is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pharmacia & Upjohn Company Llc. The primary component is Linezolid.

Product ID0009-5138_1be6b985-dd41-4264-9c2f-93d52db3641e
NDC0009-5138
Product TypeHuman Prescription Drug
Proprietary NameZyvox
Generic NameLinezolid
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-10-12
Marketing CategoryNDA / NDA
Application NumberNDA021130
Labeler NamePharmacia & Upjohn Company LLC
Substance NameLINEZOLID
Active Ingredient Strength600 mg/1
Pharm ClassesOxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0009-5138-02

20 TABLET, FILM COATED in 1 BOTTLE (0009-5138-02)
Marketing Start Date2015-10-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0009-5138-03 [00009513803]

Zyvox TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021130
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-10-12

NDC 0009-5138-02 [00009513802]

Zyvox TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021130
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-10-12

Drug Details

Active Ingredients

IngredientStrength
LINEZOLID600 mg/1

OpenFDA Data

SPL SET ID:6e70e63b-bfd5-478d-a8ee-8ba22c9efabd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1662285
  • 1662286
  • 1662278
  • 1662280
  • 581614
  • 311347
  • 262091
  • 311345
  • UPC Code
  • 0300095135022
  • 0300095138023
  • Pharmacological Class

    • 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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