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United States · US · US:0143-9534_22fd37ba-a112-4fb2-a595-d571232c792e
Linezolid
Orange BookUNIISPLATC J01XX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeJ01XX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014395341010 POUCH in 1 BOX (0143-9534-10) / 1 BAG in 1 POUCH / 300 mL in 1 BAG
Annotations
UNII (FDA Substance ID)
ISQ9I6J12J
LINEZOLID
RxCUI 190376
Orange Book
A206454
AP
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": {
"374af2a7-d994-40bd-a86a-cd9038d0b72c": {
"match": "brand_token",
"title": "LINEZOLID TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]",
"spl_version": "16",
"published_date": "2026-05-25"
}
},
"productid": "0143-9534_22fd37ba-a112-4fb2-a595-d571232c792e",
"productndc": "0143-9534",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "206454",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "600MG/300ML (2MG/ML)",
"product_no": "001",
"approval_date": "Aug 22, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LINEZOLID",
"proprietary_name": "Linezolid",
"active_ingred_unit": "mg/300mL",
"application_number": "ANDA206454",
"marketing_category": "ANDA",
"nonproprietary_name": "Linezolid",
"start_marketing_date": "20221227",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code J01XX08.
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