NDC 67919-041

SIVEXTRO

Tedizolid Phosphate

SIVEXTRO is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Tedizolid Phosphate.

Product ID67919-041_10489cbd-c2b3-48f1-aece-a39fc0f959c8
NDC67919-041
Product TypeHuman Prescription Drug
Proprietary NameSIVEXTRO
Generic NameTedizolid Phosphate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-06-20
Marketing CategoryNDA / NDA
Application NumberNDA205435
Labeler NameMerck Sharp & Dohme Corp.
Substance NameTEDIZOLID PHOSPHATE
Active Ingredient Strength200 mg/1
Pharm ClassesOxazolidinone Antibacterial [EPC],Oxazolidinones [CS],Breast Cancer Resistance Protein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 67919-041-01

30 TABLET, FILM COATED in 1 BOTTLE (67919-041-01)
Marketing Start Date2014-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67919-041-02 [67919004102]

SIVEXTRO TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205435
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-20

NDC 67919-041-01 [67919004101]

SIVEXTRO TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA205435
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-20

Drug Details

Active Ingredients

IngredientStrength
TEDIZOLID PHOSPHATE200 mg/1

OpenFDA Data

SPL SET ID:75672079-589f-451a-bdbf-eaebcfcc80a9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1540862
  • 1540868
  • 1540890
  • 1540886
  • Pharmacological Class

    • Oxazolidinone Antibacterial [EPC]
    • Oxazolidinones [CS]
    • Breast Cancer Resistance Protein Inhibitors [MoA]

    NDC Crossover Matching brand name "SIVEXTRO" or generic name "Tedizolid Phosphate"

    NDCBrand NameGeneric Name
    67919-040SIVEXTROtedizolid phosphate
    67919-041SIVEXTROtedizolid phosphate
    72000-310SIVEXTROtedizolid phosphate
    72000-320SIVEXTROtedizolid phosphate

    Trademark Results [SIVEXTRO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SIVEXTRO
    SIVEXTRO
    85750866 4597817 Live/Registered
    MERCK SHARP & DOHME CORP.
    2012-10-10

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.