ARTHROTEC

{
  "unii": {
    "unii": "QTG126297Q",
    "rxcui": "203214",
    "inchikey": "KPHWPUGNDIVLNH-UHFFFAOYSA-M",
    "display_name": "DICLOFENAC SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "600fe842-45d9-4d68-9ef2-456dbbebaa11": {
      "match": "brand_token",
      "title": "ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "38",
      "published_date": "2025-08-15"
    }
  },
  "productid": "0025-1421_2b1bf1d7-4399-46bd-8654-2590513da5c2",
  "productndc": "0025-1421",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020607",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG;0.2MG",
        "product_no": "001",
        "approval_date": "Dec 24, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "75MG;0.2MG",
        "product_no": "002",
        "approval_date": "Dec 24, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICLOFENAC SODIUM; MISOPROSTOL",
  "proprietary_name": "ARTHROTEC",
  "active_ingred_unit": "mg/1; ug/1",
  "application_number": "NDA020607",
  "marketing_category": "NDA",
  "nonproprietary_name": "diclofenac sodium and misoprostol",
  "start_marketing_date": "19971224",
  "active_numerator_strength": "75; 200"
}