RYTARY

{
  "unii": {
    "unii": "MNX7R8C5VO",
    "rxcui": "2019",
    "inchikey": "QTAOMKOIBXZKND-PPHPATTJSA-N",
    "display_name": "CARBIDOPA HYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7": {
      "match": "brand_token",
      "title": "RYTARY (CARBIDOPA AND LEVODOPA) CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "26",
      "published_date": "2026-03-27"
    }
  },
  "productid": "64896-661_ef3fe5ab-c753-409b-a5f3-b55e3eefd070",
  "productndc": "64896-661",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "203312",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "23.75MG;95MG",
        "product_no": "001",
        "approval_date": "Jan 7, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "36.25MG;145MG",
        "product_no": "002",
        "approval_date": "Jan 7, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "48.75MG;195MG",
        "product_no": "003",
        "approval_date": "Jan 7, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "61.25MG;245MG",
        "product_no": "004",
        "approval_date": "Jan 7, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBIDOPA HYDRATE; LEVODOPA",
  "proprietary_name": "RYTARY",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA203312",
  "marketing_category": "NDA",
  "nonproprietary_name": "Carbidopa and Levodopa",
  "start_marketing_date": "20150112",
  "active_numerator_strength": "23.75; 95"
}