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Moxifloxacin

NDC product · U.S. Food and Drug Administration (openFDA) · United States

  • Product NDC 63323-850
  • Package NDC 63323-850-04
  • Application number NDA205572
  • SPL ID 4070f637-059f-4e3d-8cf3-e5256a46ff3e
  • SPL set ID a4e28b09-714b-46e7-b4e6-0163cad78fc5
  • UNII C53598599T
  • RxCUI 351156

What the source publishes

Labeler
Fresenius Kabi USA, LLC
Active ingredients
MOXIFLOXACIN HYDROCHLORIDE
Form
INJECTION, SOLUTION
Routes
INTRAVENOUS
Administrative status
present-in-source-snapshot
Marketing status
NDA
Product type
HUMAN PRESCRIPTION DRUG
Prescription
Prescription or restricted

Names this record is found by

Complete source data
us:fda:ndc:63323-850_4070f637-059f-4e3d-8cf3-e5256a46ff3e 
{
  "name": "Moxifloxacin",
  "splId": "4070f637-059f-4e3d-8cf3-e5256a46ff3e",
  "labels": [
    {
      "setId": "a4e28b09-714b-46e7-b4e6-0163cad78fc5",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a4e28b09-714b-46e7-b4e6-0163cad78fc5",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=a4e28b09-714b-46e7-b4e6-0163cad78fc5"
    }
  ],
  "routes": [
    "INTRAVENOUS"
  ],
  "labeler": "Fresenius Kabi USA, LLC",
  "finished": true,
  "packaging": [
    {
      "sample": false,
      "description": "12 BAG in 1 CASE (63323-850-04)  / 250 mL in 1 BAG (63323-850-74)",
      "package_ndc": "63323-850-04",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20150318"
    }
  ],
  "productId": "63323-850_4070f637-059f-4e3d-8cf3-e5256a46ff3e",
  "useDomain": "unknown",
  "dosageForm": "INJECTION, SOLUTION",
  "productNdc": "63323-850",
  "deaSchedule": null,
  "genericName": "MOXIFLOXACIN HYDROCHLORIDE",
  "productType": "HUMAN PRESCRIPTION DRUG",
  "listingStatus": "present-in-source-snapshot",
  "targetSpecies": [],
  "approvalStatus": "not-established-by-ndc-listing",
  "labelAssociation": "openFDA-harmonized-set-ids; not a product-level approval match",
  "marketingEndDate": null,
  "activeIngredients": [
    {
      "name": "MOXIFLOXACIN HYDROCHLORIDE",
      "strength": "400 mg/250mL"
    }
  ],
  "applicationNumber": "NDA205572",
  "marketingCategory": "NDA",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20150318",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "prescription-or-restricted",
  "harmonizedIdentifiers": {
    "unii": [
      "C53598599T"
    ],
    "rxcui": [
      "351156"
    ],
    "spl_set_id": [
      "a4e28b09-714b-46e7-b4e6-0163cad78fc5"
    ],
    "manufacturer_name": [
      "Fresenius Kabi USA, LLC"
    ],
    "is_original_packager": [
      true
    ]
  },
  "listingExpirationDate": "20271231"
}

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