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United States · US · US:66298-7807_19877e50-8bfb-427d-e063-6294a90a150f

Zyvox

Orange BookUNIISPLATC J01XX08

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

Identification

ManufacturerHp Halden Pharma AS
CountryUS (United States)
ATC codeJ01XX08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6629878071
    300 mL in 1 BAG (66298-7807-1)

Annotations

UNII (FDA Substance ID)
ISQ9I6J12J
LINEZOLID
RxCUI 190376
Orange Book
N021131
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": {
    "6e70e63b-bfd5-478d-a8ee-8ba22c9efabd": {
      "match": "brand_token",
      "title": "ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) GRANULE, FOR SUSPENSION ZYVOX (LINEZOLID) TABLET, FILM COATED [PHARMACIA & UPJOHN COMPANY LLC]",
      "spl_version": "69",
      "published_date": "2026-05-28"
    }
  },
  "productid": "66298-7807_19877e50-8bfb-427d-e063-6294a90a150f",
  "productndc": "66298-7807",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "021131",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "200MG/100ML (2MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 18, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Apr 18, 2000"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "600MG/300ML (2MG/ML)",
        "product_no": "003",
        "approval_date": "Apr 18, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LINEZOLID",
  "proprietary_name": "Zyvox",
  "active_ingred_unit": "mg/300mL",
  "application_number": "NDA021131",
  "marketing_category": "NDA",
  "nonproprietary_name": "LINEZOLID",
  "start_marketing_date": "20180605",
  "active_numerator_strength": "600"
}

Related drugs

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