🇺🇸
United States · US · US:50458-596_3b408b5f-285c-68a9-e063-6294a90ad609
Risperidone
Orange BookUNIISPLATC N05AX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJanssen Pharmaceutical, Inc.
CountryUS (United States)
ATC codeN05AX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11504585960130 mL in 1 BOTTLE (50458-596-01)
Annotations
UNII (FDA Substance ID)
L6UH7ZF8HC
RISPERIDONE
RxCUI 35636
Orange Book
N020588
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "L6UH7ZF8HC",
"rxcui": "35636",
"inchikey": "RAPZEAPATHNIPO-UHFFFAOYSA-N",
"display_name": "RISPERIDONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"43aa2a4f-1123-4f86-800b-9218882f7bcd": {
"match": "brand_token",
"title": "RISPERIDONE TABLET [SOLCO HEALTHCARE US, LLC]",
"spl_version": "14",
"published_date": "2026-05-26"
}
},
"productid": "50458-596_3b408b5f-285c-68a9-e063-6294a90ad609",
"productndc": "50458-596",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "020588",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Jun 10, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RISPERIDONE",
"proprietary_name": "Risperidone",
"active_ingred_unit": "mg/mL",
"application_number": "NDA020588",
"marketing_category": "NDA",
"nonproprietary_name": "risperidone",
"start_marketing_date": "19960610",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code N05AX08.
Access this data programmatically
Query Risperidone and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.