{
  "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": "2026-09-25",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "62135-020",
      "generic_name": "Hydrocortisone",
      "labeler_name": "Chartwell RX LLC",
      "brand_name": "Hydrocortisone Rectal Suspension (Retention)",
      "active_ingredients": [
        {
          "name": "HYDROCORTISONE",
          "strength": "100 mg/60mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "62135-020-07",
          "description": "7 BOTTLE in 1 CARTON (62135-020-07)  / 60 mL in 1 BOTTLE",
          "marketing_start_date": "20210906",
          "sample": false
        },
        {
          "package_ndc": "62135-020-21",
          "description": "3 CARTON in 1 BOX (62135-020-21)  / 7 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE",
          "marketing_start_date": "20211118",
          "sample": false
        },
        {
          "package_ndc": "62135-020-46",
          "description": "1 BOTTLE in 1 CARTON (62135-020-46)  / 60 mL in 1 BOTTLE",
          "marketing_start_date": "20210906",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Chartwell RX LLC"
        ],
        "rxcui": [
          "310878"
        ],
        "spl_set_id": [
          "3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0362135020217",
          "0362135020071",
          "0362135020460"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "WI4X0X7BPJ"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "SUSPENSION",
      "spl_id": "459c2035-71cd-e07e-e063-6394a90a5a3a",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "RECTAL"
      ],
      "marketing_start_date": "19991203",
      "product_id": "62135-020_459c2035-71cd-e07e-e063-6394a90a5a3a",
      "application_number": "ANDA075172",
      "brand_name_base": "Hydrocortisone Rectal Suspension (Retention)",
      "pharm_class": [
        "Corticosteroid Hormone Receptor Agonists [MoA]",
        "Corticosteroid [EPC]"
      ]
    }
  ]
}