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United States · US · US:43386-022_74f11ed7-8e21-4310-975e-f88609d5aa4e
Linezolid
Orange BookUNIISPLATC J01XX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeJ01XX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
ISQ9I6J12J
LINEZOLID
RxCUI 190376
Orange Book
A207526
AB
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": "ORAL",
"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": "43386-022_74f11ed7-8e21-4310-975e-f88609d5aa4e",
"productndc": "43386-022",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207526",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "001",
"approval_date": "Aug 22, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LINEZOLID",
"proprietary_name": "Linezolid",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207526",
"marketing_category": "ANDA",
"nonproprietary_name": "Linezolid",
"start_marketing_date": "20160822",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code J01XX08.
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