Motofen

{
  "unii": {
    "unii": "03J5ZE7KA5",
    "rxcui": "153971",
    "inchikey": "JPKKQJKQTPNWTR-WFEZVHBLSA-N;JPKKQJKQTPNWTR-AAWIVWGASA-N",
    "display_name": "ATROPINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1fa11c67-5492-469c-9475-6bfa0e5e9ff8": {
      "match": "brand_token",
      "title": "MOTOFEN (DIFENOXIN AND ATROPINE SULFATE) TABLET [LEGACY PHARMA USA INC.]",
      "spl_version": "2",
      "published_date": "2026-03-24"
    }
  },
  "productid": "83107-011_4db25dab-3394-5f06-e063-6294a90a9688",
  "productndc": "83107-011",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "017744",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.025MG;0.5MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.025MG;1MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE",
  "shortage_reason": "Atropine Sulfate Injection",
  "shortage_status": "current",
  "proprietary_name": "Motofen",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA017744",
  "marketing_category": "NDA",
  "nonproprietary_name": "difenoxin and atropine sulfate",
  "start_marketing_date": "20260101",
  "active_numerator_strength": ".025; 1"
}