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United States · US · US:0009-7807_a31d18ac-569a-411f-a80f-5e926a1684fe

Zyvox

Orange BookUNIISPLATC J01XX08

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

Identification

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

Packs · 1

  • ndc11
    0009780702
    10 BAG in 1 BOX (0009-7807-02) / 300 mL in 1 BAG (0009-7807-01)

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": "0009-7807_a31d18ac-569a-411f-a80f-5e926a1684fe",
  "productndc": "0009-7807",
  "dosage_form": "INJECTION, SOLUTION",
  "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        "strength": "400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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": "20150218",
  "active_numerator_strength": "600"
}

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