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 ID: 67919-041_10489cbd-c2b3-48f1-aece-a39fc0f959c8
• NDC: 67919-041
• Product Type: Human Prescription Drug
• Proprietary Name: SIVEXTRO
• Generic Name: Tedizolid Phosphate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-06-20
• Marketing Category: NDA / NDA
• Application Number: NDA205435
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: TEDIZOLID PHOSPHATE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS],Breast Cancer Resistance Protein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 67919-041-01

30 TABLET, FILM COATED in 1 BOTTLE (67919-041-01)

• Marketing Start Date: 2014-06-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67919-041-02 [67919004102]

SIVEXTRO TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205435
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-06-20

NDC 67919-041-01 [67919004101]

SIVEXTRO TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA205435
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-06-20

Drug Details

Active Ingredients

Ingredient	Strength
TEDIZOLID PHOSPHATE	200 mg/1

OpenFDA Data

• SPL SET ID: 75672079-589f-451a-bdbf-eaebcfcc80a9
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • O7DRJ6R4DW
• 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"

NDC	Brand Name	Generic Name
67919-040	SIVEXTRO	tedizolid phosphate
67919-041	SIVEXTRO	tedizolid phosphate
72000-310	SIVEXTRO	tedizolid phosphate
72000-320	SIVEXTRO	tedizolid phosphate