{
  "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": "63187-538",
      "generic_name": "valacyclovir hydrochloride",
      "labeler_name": "Proficient Rx LP",
      "brand_name": "valacyclovir hydrochloride",
      "active_ingredients": [
        {
          "name": "VALACYCLOVIR HYDROCHLORIDE",
          "strength": "1 g/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "63187-538-04",
          "description": "4 TABLET, FILM COATED in 1 BOTTLE (63187-538-04)",
          "marketing_start_date": "20150901",
          "sample": false
        },
        {
          "package_ndc": "63187-538-14",
          "description": "14 TABLET, FILM COATED in 1 BOTTLE (63187-538-14)",
          "marketing_start_date": "20150901",
          "sample": false
        },
        {
          "package_ndc": "63187-538-30",
          "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-538-30)",
          "marketing_start_date": "20150901",
          "sample": false
        },
        {
          "package_ndc": "63187-538-60",
          "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-538-60)",
          "marketing_start_date": "20150901",
          "sample": false
        },
        {
          "package_ndc": "63187-538-90",
          "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-538-90)",
          "marketing_start_date": "20150901",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "Proficient Rx LP"
        ],
        "rxcui": [
          "313564"
        ],
        "spl_set_id": [
          "efe37bd1-a236-43cc-828c-b57e8a704d67"
        ],
        "unii": [
          "G447S0T1VC"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET, FILM COATED",
      "spl_id": "0ac3f14c-c375-408e-a1d7-8412e3420a40",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20120405",
      "product_id": "63187-538_0ac3f14c-c375-408e-a1d7-8412e3420a40",
      "application_number": "ANDA201506",
      "brand_name_base": "valacyclovir hydrochloride",
      "pharm_class": [
        "DNA Polymerase Inhibitors [MoA]",
        "Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]",
        "Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]",
        "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]",
        "Nucleoside Analog [EXT]"
      ]
    }
  ]
}