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United States · US · US:59762-1307_c553c285-1954-4f89-8988-3bada9c4a65e
Linezolid
Orange BookUNIISPLATC J01XX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01XX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11597621307220 BLISTER PACK in 1 BOX, UNIT-DOSE (59762-1307-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
ISQ9I6J12J
LINEZOLID
RxCUI 190376
Orange Book
N021130
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": "59762-1307_c553c285-1954-4f89-8988-3bada9c4a65e",
"productndc": "59762-1307",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "021130",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Apr 18, 2000"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "600MG",
"product_no": "002",
"approval_date": "Apr 18, 2000"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LINEZOLID",
"proprietary_name": "Linezolid",
"active_ingred_unit": "mg/1",
"application_number": "NDA021130",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "linezolid",
"start_marketing_date": "20151012",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code J01XX08.
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