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United States · US · US:33342-352_90dd8c13-c428-4472-91e5-5b1fcdc4fce3
Linezolid
Orange BookUNIISPLATC J01XX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeJ01XX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc113334235211100 TABLET, COATED in 1 BOTTLE (33342-352-11)
- ndc1133342352315 BLISTER PACK in 1 CARTON (33342-352-31) / 10 TABLET, COATED in 1 BLISTER PACK
- ndc11333423523220 TABLET, COATED in 1 BOTTLE (33342-352-32)
Annotations
UNII (FDA Substance ID)
ISQ9I6J12J
LINEZOLID
RxCUI 190376
Orange Book
A210378
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": "33342-352_90dd8c13-c428-4472-91e5-5b1fcdc4fce3",
"productndc": "33342-352",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "210378",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "Oct 10, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LINEZOLID",
"proprietary_name": "Linezolid",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210378",
"marketing_category": "ANDA",
"nonproprietary_name": "Linezolid",
"start_marketing_date": "20241010",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code J01XX08.
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