APADAZ

{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "0590d4e5-7107-4015-a6a8-deac14265aa2": {
      "match": "brand_token",
      "title": "APADAZ (BENZHYDROCODONE AND ACETAMINOPHEN) TABLET [ZEVRA THERAPEUTICS, INC.]",
      "spl_version": "5",
      "published_date": "2025-01-08"
    }
  },
  "productid": "70040-0167_29a56d99-ac58-69d0-e063-6394a90a32a0",
  "productndc": "70040-0167",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208653",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "325MG;EQ 6.12MG BASE",
        "product_no": "001",
        "approval_date": "Feb 23, 2018"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "325MG;EQ 4.08MG BASE",
        "product_no": "002",
        "approval_date": "Jan 4, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "325MG;EQ 8.16MG BASE",
        "product_no": "003",
        "approval_date": "Jan 4, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "APADAZ",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA208653",
  "marketing_category": "NDA",
  "nonproprietary_name": "Benzhydrocodone and Acetaminophen",
  "start_marketing_date": "20180223",
  "active_numerator_strength": "325; 6.12"
}