Diphenoxylate Hydrochloride and Atropine Sulfate

{
  "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": {
    "bd08ed90-dd26-4629-83c0-0f75af6ebb95": {
      "match": "brand_token",
      "title": "DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "8",
      "published_date": "2026-05-25"
    }
  },
  "productid": "43353-594_ef69e563-7239-4c78-8fb4-3cd641fbff17",
  "productndc": "43353-594",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "086727",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "0.025MG;2.5MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE",
  "shortage_reason": "Atropine Sulfate Injection",
  "shortage_status": "current",
  "proprietary_name": "Diphenoxylate Hydrochloride and Atropine Sulfate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA086727",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diphenoxylate Hydrochloride and Atropine Sulfate",
  "start_marketing_date": "20170620",
  "active_numerator_strength": ".025; 2.5"
}