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Ondansetron Hydrochloride

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

  • Product NDC 42708-059
  • Package NDC 42708-059-05
  • Application number ANDA078539
  • SPL ID 4652e75e-e926-67a7-e063-6294a90a850c
  • SPL set ID dafe875e-391f-47a2-97b7-89840a760e44
  • UNII NMH84OZK2B
  • RxCUI 312086

What the source publishes

Labeler
QPharma, Inc.
Active ingredients
Ondansetron Hydrochloride
Form
TABLET, FILM COATED
Routes
ORAL
Administrative status
present-in-source-snapshot
Marketing status
ANDA
Product type
HUMAN PRESCRIPTION DRUG
Prescription
Prescription or restricted

Names this record is found by

Complete source data
us:fda:ndc:42708-059_4652e75e-e926-67a7-e063-6294a90a850c 
{
  "name": "Ondansetron Hydrochloride",
  "splId": "4652e75e-e926-67a7-e063-6294a90a850c",
  "labels": [
    {
      "setId": "dafe875e-391f-47a2-97b7-89840a760e44",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dafe875e-391f-47a2-97b7-89840a760e44",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=dafe875e-391f-47a2-97b7-89840a760e44"
    }
  ],
  "routes": [
    "ORAL"
  ],
  "labeler": "QPharma, Inc.",
  "finished": true,
  "packaging": [
    {
      "sample": true,
      "description": "5 TABLET, FILM COATED in 1 BOTTLE (42708-059-05)",
      "package_ndc": "42708-059-05",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20180419"
    }
  ],
  "productId": "42708-059_4652e75e-e926-67a7-e063-6294a90a850c",
  "useDomain": "unknown",
  "dosageForm": "TABLET, FILM COATED",
  "productNdc": "42708-059",
  "deaSchedule": null,
  "genericName": "Ondansetron 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": "ONDANSETRON HYDROCHLORIDE",
      "strength": "8 mg/1"
    }
  ],
  "applicationNumber": "ANDA078539",
  "marketingCategory": "ANDA",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20070731",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "prescription-or-restricted",
  "harmonizedIdentifiers": {
    "unii": [
      "NMH84OZK2B"
    ],
    "rxcui": [
      "312086"
    ],
    "spl_set_id": [
      "dafe875e-391f-47a2-97b7-89840a760e44"
    ],
    "manufacturer_name": [
      "QPharma, Inc."
    ]
  },
  "listingExpirationDate": "20261231"
}

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  --data-urlencode "id=us:fda:ndc:42708-059_4652e75e-e926-67a7-e063-6294a90a850c"