🇺🇸
United States · US · US:57664-682_2e599906-ac35-54ab-e063-6394a90ac605
Linezolid
Orange BookUNIISPLATC J01XX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeJ01XX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115766468230100 mL in 1 BAG (57664-682-30)
Annotations
UNII (FDA Substance ID)
ISQ9I6J12J
LINEZOLID
RxCUI 190376
Orange Book
A207354
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": {
"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": "57664-682_2e599906-ac35-54ab-e063-6394a90ac605",
"productndc": "57664-682",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "207354",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "200MG/100ML (2MG/ML)",
"product_no": "001",
"approval_date": "Dec 20, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "600MG/300ML (2MG/ML)",
"product_no": "002",
"approval_date": "Dec 20, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LINEZOLID",
"proprietary_name": "Linezolid",
"active_ingred_unit": "mg/100mL",
"application_number": "ANDA207354",
"marketing_category": "ANDA",
"nonproprietary_name": "linezolid",
"start_marketing_date": "20170201",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code J01XX08.
Access this data programmatically
Query Linezolid and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.