ARISTADA

{
  "unii": {
    "unii": "B786J7A343",
    "rxcui": "1673265",
    "inchikey": "DDINXHAORAAYAD-UHFFFAOYSA-N",
    "display_name": "ARIPIPRAZOLE LAUROXIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403": {
      "match": "brand_token",
      "title": "ARISTADA INITIO (ARIPIPRAZOLE LAUROXIL) INJECTION, SUSPENSION, EXTENDED RELEASE [ALKERMES, INC.]",
      "spl_version": "16",
      "published_date": "2025-02-10"
    }
  },
  "productid": "65757-402_3d951a36-1e73-4f84-8ebf-4d556d81a086",
  "productndc": "65757-402",
  "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "207533",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "441MG/1.6ML (275.63MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 5, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "662MG/2.4ML (275.83MG/ML)",
        "product_no": "002",
        "approval_date": "Oct 5, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "882MG/3.2ML (275.63MG/ML)",
        "product_no": "003",
        "approval_date": "Oct 5, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1064MG/3.9ML (272.82MG/ML)",
        "product_no": "004",
        "approval_date": "Jun 5, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARIPIPRAZOLE LAUROXIL",
  "proprietary_name": "ARISTADA",
  "active_ingred_unit": "mg/2.4mL",
  "application_number": "NDA207533",
  "marketing_category": "NDA",
  "nonproprietary_name": "aripiprazole lauroxil",
  "start_marketing_date": "20151005",
  "active_numerator_strength": "662"
}