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United States Β· US Β· US:72526-104_4701fbbb-2d07-4b47-9596-4255a49c7dbc

Rykindo

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerShandong Luye Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC codeβ€”
Dispensingβ€”
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs Β· 0

No packs registered.

Annotations

Orange Book
N212849
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "58534c96-96f5-4c2e-a061-92d4506aee91": {
      "match": "brand_token",
      "title": "RYKINDO EXTENDED-RELEASE MICROSPHERES (RISPERIDONE) KIT [SHANDONG LUYE PHARMACEUTICAL CO., LTD.]",
      "spl_version": "10",
      "published_date": "2026-05-28"
    }
  },
  "productid": "72526-104_4701fbbb-2d07-4b47-9596-4255a49c7dbc",
  "productndc": "72526-104",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "212849",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Jan 13, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Jan 13, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "37.5MG",
        "product_no": "003",
        "approval_date": "Jan 13, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "004",
        "approval_date": "Jan 13, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Rykindo",
  "active_ingred_unit": null,
  "application_number": "NDA212849",
  "marketing_category": "NDA",
  "nonproprietary_name": "Risperidone",
  "start_marketing_date": "20230620",
  "active_numerator_strength": null
}

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