AZSTARYS

{
  "unii": {
    "unii": "1678OK0E08",
    "rxcui": "353105",
    "inchikey": "JUMYIBMBTDDLNG-OJERSXHUSA-N",
    "display_name": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "00b5e716-5564-4bbd-acaf-df2bc45a5663": {
      "match": "brand_token",
      "title": "AZSTARYS (SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE) CAPSULE [COMMAVE SUB, LLC]",
      "spl_version": "9",
      "published_date": "2026-05-13"
    }
  },
  "productid": "65038-561_515506d2-5c3d-92d2-e063-6394a90a0603",
  "productndc": "65038-561",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "212994",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5.2MG BASE;EQ 26.1MG BASE",
        "product_no": "001",
        "approval_date": "May 7, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 7.8MG BASE;EQ 39.2MG BASE",
        "product_no": "002",
        "approval_date": "May 7, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10.4MG BASE;EQ 52.3MG BASE",
        "product_no": "003",
        "approval_date": "May 7, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE",
  "proprietary_name": "AZSTARYS",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA212994",
  "marketing_category": "NDA",
  "nonproprietary_name": "Serdexmethylphenidate and Dexmethylphenidate",
  "start_marketing_date": "20210716",
  "active_numerator_strength": "10.4; 52.3"
}