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Cefadroxil

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

  • Product NDC 65862-085
  • Package NDC 65862-085-01
  • Package NDC 65862-085-50
  • Application number ANDA065352
  • SPL ID 58128541-059d-4ef1-9dbf-98fa1befdcf0
  • SPL set ID 7bb90096-14d3-400e-94d3-048bff6b1292
  • UNII 280111G160
  • RxCUI 309049

What the source publishes

Labeler
Aurobindo Pharma Limited
Active ingredients
Cefadroxil
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:65862-085_58128541-059d-4ef1-9dbf-98fa1befdcf0 
{
  "name": "Cefadroxil",
  "splId": "58128541-059d-4ef1-9dbf-98fa1befdcf0",
  "labels": [
    {
      "setId": "7bb90096-14d3-400e-94d3-048bff6b1292",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7bb90096-14d3-400e-94d3-048bff6b1292",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=7bb90096-14d3-400e-94d3-048bff6b1292"
    }
  ],
  "routes": [
    "ORAL"
  ],
  "labeler": "Aurobindo Pharma Limited",
  "finished": true,
  "packaging": [
    {
      "sample": false,
      "description": "100 CAPSULE in 1 BOTTLE (65862-085-01)",
      "package_ndc": "65862-085-01",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20070125"
    },
    {
      "sample": false,
      "description": "50 CAPSULE in 1 BOTTLE (65862-085-50)",
      "package_ndc": "65862-085-50",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20070125"
    }
  ],
  "productId": "65862-085_58128541-059d-4ef1-9dbf-98fa1befdcf0",
  "useDomain": "unknown",
  "dosageForm": "CAPSULE",
  "productNdc": "65862-085",
  "deaSchedule": null,
  "genericName": "Cefadroxil",
  "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": "CEFADROXIL",
      "strength": "500 mg/1"
    }
  ],
  "applicationNumber": "ANDA065352",
  "marketingCategory": "ANDA",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20070125",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "prescription-or-restricted",
  "harmonizedIdentifiers": {
    "unii": [
      "280111G160"
    ],
    "rxcui": [
      "309049"
    ],
    "spl_set_id": [
      "7bb90096-14d3-400e-94d3-048bff6b1292"
    ],
    "manufacturer_name": [
      "Aurobindo Pharma Limited"
    ],
    "is_original_packager": [
      true
    ]
  },
  "listingExpirationDate": "20261231"
}

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  --data-urlencode "id=us:fda:ndc:65862-085_58128541-059d-4ef1-9dbf-98fa1befdcf0"