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United States · US · US:71335-2565_c8913686-e7a0-451f-a345-9a8fd6e167df

Linezolid

Orange BookUNIISPLATC J01XX08

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeJ01XX08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7133525651
    20 TABLET, FILM COATED in 1 BOTTLE (71335-2565-1)

Annotations

UNII (FDA Substance ID)
ISQ9I6J12J
LINEZOLID
RxCUI 190376
Orange Book
A205517
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": "71335-2565_c8913686-e7a0-451f-a345-9a8fd6e167df",
  "productndc": "71335-2565",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205517",
    "products": [
      {
        "rs": true,
        "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": "ANDA205517",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Linezolid",
  "start_marketing_date": "20151221",
  "active_numerator_strength": "600"
}

Related drugs

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