sivextro

Generic: tedizolid phosphate

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sivextro
Generic Name tedizolid phosphate
Labeler merck sharp & dohme llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tedizolid phosphate 200 mg/4mL

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 67919-040
Product ID 67919-040_3132b965-d332-43a4-a156-d29b7d0fab8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205436
Listing Expiration 2026-12-31
Marketing Start 2014-06-20

Pharmacologic Class

Classes
breast cancer resistance protein inhibitors [moa] oxazolidinone antibacterial [epc] oxazolidinones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67919040
Hyphenated Format 67919-040

Supplemental Identifiers

RxCUI
1540862 1540868 1540886 1540890
UNII
O7DRJ6R4DW

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sivextro (source: ndc)
Generic Name tedizolid phosphate (source: ndc)
Application Number NDA205436 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/4mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 CARTON (67919-040-02) / 4 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

67919-040-02 10 VIAL, GLASS in 1 CARTON (67919-040-02) / 4 mL in 1 VIAL, GLASS

Ingredients (1)

tedizolid phosphate (200 mg/4mL)

Linked Drug Pages (1)

SIVEXTRO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3132b965-d332-43a4-a156-d29b7d0fab8d", "openfda": {"unii": ["O7DRJ6R4DW"], "rxcui": ["1540862", "1540868", "1540886", "1540890"], "spl_set_id": ["75672079-589f-451a-bdbf-eaebcfcc80a9"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (67919-040-02)  / 4 mL in 1 VIAL, GLASS", "package_ndc": "67919-040-02", "marketing_start_date": "20140620"}], "brand_name": "SIVEXTRO", "product_id": "67919-040_3132b965-d332-43a4-a156-d29b7d0fab8d", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Oxazolidinone Antibacterial [EPC]", "Oxazolidinones [CS]"], "product_ndc": "67919-040", "generic_name": "tedizolid phosphate", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SIVEXTRO", "active_ingredients": [{"name": "TEDIZOLID PHOSPHATE", "strength": "200 mg/4mL"}], "application_number": "NDA205436", "marketing_category": "NDA", "marketing_start_date": "20140620", "listing_expiration_date": "20261231"}