{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 13
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20210106",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20200506",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "54785",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210720Orig1s000ltr.pdf",
              "date": "20200604",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "ANDA210720",
      "sponsor_name": "TARO",
      "openfda": {
        "application_number": [
          "ANDA210720"
        ],
        "brand_name": [
          "IVERMECTIN",
          "RID ONE AND DONE"
        ],
        "generic_name": [
          "IVERMECTIN"
        ],
        "manufacturer_name": [
          "AmerisourceBergen",
          "Walgreen Company",
          "Belmora LLC",
          "WALMART INC.",
          "YYBA Corp",
          "Oystershell Consumer Health, Inc.",
          "Sun Pharmaceutical Industries, Inc.",
          "CVS Pharmacy",
          "Azurity Pharmaceuticals, Inc.",
          "Rite Aid Corporation"
        ],
        "product_ndc": [
          "46122-827",
          "0363-4230",
          "27854-334",
          "79903-154",
          "73581-021",
          "82392-200",
          "51672-4230",
          "51316-985",
          "24338-119",
          "11822-4230"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "IVERMECTIN"
        ],
        "rxcui": [
          "1246673"
        ],
        "spl_id": [
          "4f9549d0-8c2f-d3b3-e063-6294a90aec31",
          "45704375-b8e9-482f-ae1c-43d6abebad67",
          "24b0813f-ac85-aa4d-e063-6394a90a8a19",
          "2b4be691-2fcd-a688-e063-6294a90a921b",
          "59ea9772-20ab-ebe2-e063-6294a90a698f",
          "2fc2e0fd-e442-d3f5-e063-6394a90a8473",
          "468c6f20-854b-ec91-e063-6394a90aeaa1",
          "3802b5f4-b108-3614-e063-6294a90a6674",
          "58c9cc5a-56e2-0e49-e063-6394a90a4264",
          "1f81eef3-2ffd-2759-e063-6394a90a3ec2"
        ],
        "spl_set_id": [
          "4e924212-cd7b-ccd9-e063-6394a90afb95",
          "b8e1d919-ba66-4dc0-b0fc-cfb3a229dad9",
          "0d405318-3db5-41b6-a248-a6c1cfe7a765",
          "1608ec4a-2af4-4a43-a83f-5b25937068d1",
          "59ea9767-2e0b-ebc2-e063-6294a90ab904",
          "731a15f8-3578-4a95-b04c-aa6cf44a4665",
          "dd2c66e6-bd50-46df-a335-26215d02d13b",
          "326e85c6-b95f-6aa8-e063-6294a90a4985",
          "58c9cc4d-b1f3-1b6f-e063-6294a90ab597",
          "3a2eb7f3-b72b-435c-a609-ce7050cccff4"
        ],
        "package_ndc": [
          "46122-827-36",
          "0363-4230-08",
          "27854-334-01",
          "79903-154-01",
          "73581-021-04",
          "82392-200-04",
          "51672-4230-8",
          "51316-985-08",
          "24338-119-45",
          "11822-4230-8"
        ],
        "nui": [
          "N0000175484",
          "N0000181811"
        ],
        "pharm_class_epc": [
          "Antiparasitic [EPC]",
          "Pediculicide [EPC]"
        ],
        "unii": [
          "8883YP2R6D"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "IVERMECTIN",
          "active_ingredients": [
            {
              "name": "IVERMECTIN",
              "strength": "0.5%"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "LOTION",
          "route": "TOPICAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}