Zubsolv

{
  "unii": {
    "unii": "56W8MW3EN1",
    "rxcui": "203841",
    "inchikey": "UAIXRPCCYXNJMQ-RZIPZOSSSA-N",
    "display_name": "BUPRENORPHINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBLINGUAL",
  "spl_meta": {
    "5f5cfcfe-d52b-49e6-8fe4-550477332dd2": {
      "match": "brand_token",
      "title": "ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]",
      "spl_version": "27",
      "published_date": "2025-12-31"
    }
  },
  "productid": "54123-986_8c67e97f-118f-4226-972a-a9031ef6f5ce",
  "productndc": "54123-986",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "204242",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1.4MG BASE;EQ 0.36MG BASE",
        "product_no": "001",
        "approval_date": "Jul 3, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5.7MG BASE;EQ 1.4MG BASE",
        "product_no": "002",
        "approval_date": "Jul 3, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 8.6MG BASE;EQ 2.1MG BASE",
        "product_no": "003",
        "approval_date": "Dec 11, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 11.4MG BASE;EQ 2.9MG BASE",
        "product_no": "004",
        "approval_date": "Dec 11, 2014"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2.9MG BASE;EQ 0.71MG BASE",
        "product_no": "005",
        "approval_date": "Jun 4, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.7MG BASE;EQ 0.18MG BASE",
        "product_no": "006",
        "approval_date": "Oct 4, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE",
  "proprietary_name": "Zubsolv",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA204242",
  "marketing_category": "NDA",
  "nonproprietary_name": "buprenorphine hydrochloride and naloxone hydrochloride",
  "start_marketing_date": "20141211",
  "active_numerator_strength": "8.6; 2.1"
}