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United States · US · US:67919-040_340a4655-ccf2-4c0f-a305-7576c06f4518
SIVEXTRO
Orange BookUNIISPLATC J01XX11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC codeJ01XX11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11679190400210 VIAL, GLASS in 1 CARTON (67919-040-02) / 4 mL in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
O7DRJ6R4DW
TEDIZOLID PHOSPHATE
RxCUI 1540824
Orange Book
N205436
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "O7DRJ6R4DW",
"rxcui": "1540824",
"inchikey": "QCGUSIANLFXSGE-GFCCVEGCSA-N",
"display_name": "TEDIZOLID PHOSPHATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"75672079-589f-451a-bdbf-eaebcfcc80a9": {
"match": "brand_token",
"title": "SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]",
"spl_version": "34",
"published_date": "2026-03-16"
}
},
"productid": "67919-040_340a4655-ccf2-4c0f-a305-7576c06f4518",
"productndc": "67919-040",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "205436",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "200MG/VIAL",
"product_no": "001",
"approval_date": "Jun 20, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TEDIZOLID PHOSPHATE",
"proprietary_name": "SIVEXTRO",
"active_ingred_unit": "mg/4mL",
"application_number": "NDA205436",
"marketing_category": "NDA",
"nonproprietary_name": "tedizolid phosphate",
"start_marketing_date": "20140620",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code J01XX11.
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