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United States · US · US:0009-7807_a31d18ac-569a-411f-a80f-5e926a1684fe
Zyvox
Orange BookUNIISPLATC J01XX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPharmacia & Upjohn Company LLC
CountryUS (United States)
ATC codeJ01XX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11000978070210 BAG in 1 BOX (0009-7807-02) / 300 mL in 1 BAG (0009-7807-01)
Annotations
UNII (FDA Substance ID)
ISQ9I6J12J
LINEZOLID
RxCUI 190376
Orange Book
N021131
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "ISQ9I6J12J",
"rxcui": "190376",
"inchikey": "TYZROVQLWOKYKF-ZDUSSCGKSA-N",
"display_name": "LINEZOLID",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"6e70e63b-bfd5-478d-a8ee-8ba22c9efabd": {
"match": "brand_token",
"title": "ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) GRANULE, FOR SUSPENSION ZYVOX (LINEZOLID) TABLET, FILM COATED [PHARMACIA & UPJOHN COMPANY LLC]",
"spl_version": "69",
"published_date": "2026-05-28"
}
},
"productid": "0009-7807_a31d18ac-569a-411f-a80f-5e926a1684fe",
"productndc": "0009-7807",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "021131",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "200MG/100ML (2MG/ML)",
"product_no": "001",
"approval_date": "Apr 18, 2000"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Apr 18, 2000"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "600MG/300ML (2MG/ML)",
"product_no": "003",
"approval_date": "Apr 18, 2000"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LINEZOLID",
"proprietary_name": "Zyvox",
"active_ingred_unit": "mg/300mL",
"application_number": "NDA021131",
"marketing_category": "NDA",
"nonproprietary_name": "linezolid",
"start_marketing_date": "20150218",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code J01XX08.
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