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United States · US · US:62332-183_008b01d8-4425-4317-a172-4cc2a9e4e39d

Linezolid

Orange BookUNIISPLATC J01XX08

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01XX08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6233218320
    20 TABLET, FILM COATED in 1 BOTTLE (62332-183-20)
  • ndc11
    6233218330
    30 TABLET, FILM COATED in 1 BOTTLE (62332-183-30)
  • ndc11
    6233218331
    100 TABLET, FILM COATED in 1 BOTTLE (62332-183-31)
  • ndc11
    6233218391
    1000 TABLET, FILM COATED in 1 BOTTLE (62332-183-91)

Annotations

UNII (FDA Substance ID)
ISQ9I6J12J
LINEZOLID
RxCUI 190376
Orange Book
A205233
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": "62332-183_008b01d8-4425-4317-a172-4cc2a9e4e39d",
  "productndc": "62332-183",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205233",
    "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": "ANDA205233",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Linezolid",
  "start_marketing_date": "20151222",
  "active_numerator_strength": "600"
}

Related drugs

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