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United States · US · US:85766-075_50317545-8e72-a9c1-e063-6394a90a1c8d

Linezolid

Orange BookUNIISPLATC J01XX08

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeJ01XX08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8576607520
    20 TABLET in 1 BOTTLE (85766-075-20)
  • ndc11
    8576607530
    30 TABLET in 1 BOTTLE (85766-075-30)

Annotations

UNII (FDA Substance ID)
ISQ9I6J12J
LINEZOLID
RxCUI 190376
Orange Book
A078845
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": "85766-075_50317545-8e72-a9c1-e063-6394a90a1c8d",
  "productndc": "85766-075",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078845",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Dec 21, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LINEZOLID",
  "proprietary_name": "Linezolid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078845",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Linezolid",
  "start_marketing_date": "20231120",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code J01XX08.

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