TAPENTADOL

{
  "unii": {
    "unii": "71204KII53",
    "rxcui": "857492",
    "inchikey": "ZELFLGGRLLOERW-YECZQDJWSA-N",
    "display_name": "TAPENTADOL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "863f3fd3-1e8d-41b0-855f-8f9a29237cda": {
      "match": "brand_token",
      "title": "TAPENTADOL (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "2",
      "published_date": "2026-03-05"
    }
  },
  "productid": "0054-0939_7fef46e2-c049-44d8-962f-fdd233dad041",
  "productndc": "0054-0939",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "200533",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Aug 25, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Aug 25, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 150MG BASE",
        "product_no": "003",
        "approval_date": "Aug 25, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 200MG BASE",
        "product_no": "004",
        "approval_date": "Aug 25, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 250MG BASE",
        "product_no": "005",
        "approval_date": "Aug 25, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAPENTADOL HYDROCHLORIDE",
  "proprietary_name": "TAPENTADOL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA200533",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Tapentadol Hydrochloride",
  "start_marketing_date": "20251215",
  "active_numerator_strength": "200"
}