Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate

{
  "unii": {
    "unii": "56W8MW3EN1",
    "rxcui": "203841",
    "inchikey": "UAIXRPCCYXNJMQ-RZIPZOSSSA-N",
    "display_name": "BUPRENORPHINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBLINGUAL",
  "spl_meta": {
    "2738feae-316e-426f-971c-5f142ac01b60": {
      "match": "brand_token",
      "title": "BUPRENORPHINE PATCH [RHODES PHARMACEUTICALS LLC]",
      "spl_version": "17",
      "published_date": "2026-06-01"
    }
  },
  "productid": "71335-1725_8a668a34-0be3-4aa9-8c87-3e9648f480cf",
  "productndc": "71335-1725",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207000",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2MG BASE;EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Dec 13, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE;EQ 2MG BASE",
        "product_no": "002",
        "approval_date": "Dec 13, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE",
  "proprietary_name": "Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA207000",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate",
  "start_marketing_date": "20171213",
  "active_numerator_strength": "8; 2"
}