Hydrocodone Bitartrate and Homatropine Methylbromide

{
  "unii": {
    "unii": "68JRS2HC1C",
    "rxcui": "27085",
    "inchikey": "FUFVKLQESJNNAN-RIMUKSHESA-M",
    "display_name": "HOMATROPINE METHYLBROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1f9c1adc-f84f-43de-af5c-d93703aba7f8": {
      "match": "brand_token",
      "title": "HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [RHODES PHARMACEUTICALS LLC]",
      "spl_version": "20",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0121-1036_3b3068f2-238d-46b3-b80d-a0ae90142908",
  "productndc": "0121-1036",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "005213",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AA",
        "strength": "1.5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jul 26, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AA",
        "strength": "1.5MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Jul 26, 1988"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE",
  "shortage_reason": "Homatropine Methylbromide and Hydrocodone Bitartrate Syrup",
  "shortage_status": "current",
  "proprietary_name": "Hydrocodone Bitartrate and Homatropine Methylbromide",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "NDA005213",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Hydrocodone Bitartrate and Homatropine Methylbromide",
  "start_marketing_date": "20240805",
  "active_numerator_strength": "1.5; 5"
}