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Atomoxetine Hydrochloride

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

  • Product NDC 50268-059
  • Package NDC 50268-059-13
  • Application number ANDA078983
  • SPL ID 4587bd5f-1bd2-c809-e063-6294a90adf87
  • SPL set ID a9df4617-b406-70ba-e053-2995a90a28e8
  • UNII 57WVB6I2W0
  • RxCUI 349595

What the source publishes

Labeler
AvPAK
Active ingredients
atomoxetine hydrochloride
Form
CAPSULE
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:50268-059_4587bd5f-1bd2-c809-e063-6294a90adf87 
{
  "name": "Atomoxetine Hydrochloride",
  "splId": "4587bd5f-1bd2-c809-e063-6294a90adf87",
  "labels": [
    {
      "setId": "a9df4617-b406-70ba-e053-2995a90a28e8",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a9df4617-b406-70ba-e053-2995a90a28e8",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=a9df4617-b406-70ba-e053-2995a90a28e8"
    }
  ],
  "routes": [
    "ORAL"
  ],
  "labeler": "AvPAK",
  "finished": true,
  "packaging": [
    {
      "sample": false,
      "description": "30 BLISTER PACK in 1 BOX (50268-059-13)  / 1 CAPSULE in 1 BLISTER PACK (50268-059-11)",
      "package_ndc": "50268-059-13",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20200707"
    }
  ],
  "productId": "50268-059_4587bd5f-1bd2-c809-e063-6294a90adf87",
  "useDomain": "unknown",
  "dosageForm": "CAPSULE",
  "productNdc": "50268-059",
  "deaSchedule": null,
  "genericName": "atomoxetine 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": "ATOMOXETINE HYDROCHLORIDE",
      "strength": "60 mg/1"
    }
  ],
  "applicationNumber": "ANDA078983",
  "marketingCategory": "ANDA",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20200707",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "prescription-or-restricted",
  "harmonizedIdentifiers": {
    "unii": [
      "57WVB6I2W0"
    ],
    "rxcui": [
      "349595"
    ],
    "spl_set_id": [
      "a9df4617-b406-70ba-e053-2995a90a28e8"
    ],
    "manufacturer_name": [
      "AvPAK"
    ]
  },
  "listingExpirationDate": "20261231"
}

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  --data-urlencode "id=us:fda:ndc:50268-059_4587bd5f-1bd2-c809-e063-6294a90adf87"