{
  "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": 1
    }
  },
  "results": [
    {
      "product_ndc": "54348-625",
      "generic_name": "SULFAMETHOXAZOLE, TRIMETHOPRIM",
      "labeler_name": "PharmPak, Inc.",
      "brand_name": "Sulfamethox-TMP DS",
      "active_ingredients": [
        {
          "name": "SULFAMETHOXAZOLE",
          "strength": "800 mg/1"
        },
        {
          "name": "TRIMETHOPRIM",
          "strength": "160 mg/1"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "54348-625-06",
          "description": "1 BOTTLE in 1 BOX (54348-625-06)  / 6 TABLET in 1 BOTTLE",
          "marketing_start_date": "20190711",
          "sample": false
        },
        {
          "package_ndc": "54348-625-10",
          "description": "1 BOTTLE in 1 BOX (54348-625-10)  / 10 TABLET in 1 BOTTLE",
          "marketing_start_date": "20190711",
          "sample": false
        },
        {
          "package_ndc": "54348-625-14",
          "description": "1 BOTTLE in 1 BOX (54348-625-14)  / 14 TABLET in 1 BOTTLE",
          "marketing_start_date": "20190711",
          "sample": false
        },
        {
          "package_ndc": "54348-625-20",
          "description": "1 BOTTLE in 1 BOX (54348-625-20)  / 20 TABLET in 1 BOTTLE",
          "marketing_start_date": "20190711",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {
        "manufacturer_name": [
          "PharmPak, Inc."
        ],
        "rxcui": [
          "198335"
        ],
        "spl_set_id": [
          "ede74118-32c5-4f52-9823-509538e674c8"
        ],
        "nui": [
          "N0000175504",
          "M0020790",
          "N0000185504",
          "N0000175489",
          "N0000000191",
          "N0000187062",
          "N0000187061"
        ],
        "pharm_class_epc": [
          "Sulfonamide Antimicrobial [EPC]",
          "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Sulfonamides [CS]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 2C9 Inhibitors [MoA]",
          "Dihydrofolate Reductase Inhibitors [MoA]",
          "Cytochrome P450 2C8 Inhibitors [MoA]",
          "Organic Cation Transporter 2 Inhibitors [MoA]"
        ],
        "unii": [
          "JE42381TNV",
          "AN164J8Y0X"
        ]
      },
      "marketing_category": "ANDA",
      "dosage_form": "TABLET",
      "spl_id": "ea935f93-6c2d-2e8a-e053-2995a90a2ce0",
      "product_type": "HUMAN PRESCRIPTION DRUG",
      "route": [
        "ORAL"
      ],
      "marketing_start_date": "20190711",
      "product_id": "54348-625_ea935f93-6c2d-2e8a-e053-2995a90a2ce0",
      "application_number": "ANDA076899",
      "brand_name_base": "Sulfamethox-TMP DS",
      "pharm_class": [
        "Cytochrome P450 2C8 Inhibitors [MoA]",
        "Cytochrome P450 2C9 Inhibitors [MoA]",
        "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]",
        "Dihydrofolate Reductase Inhibitors [MoA]",
        "Organic Cation Transporter 2 Inhibitors [MoA]",
        "Sulfonamide Antimicrobial [EPC]",
        "Sulfonamides [CS]"
      ]
    }
  ]
}