πΊπΈ
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
}Access this data programmatically
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