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United States · US · US:42291-979_3d4c5818-d71d-e4d0-e063-6394a90a9679
Risperidone
Orange BookUNIISPLATC N05AX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvKARE
CountryUS (United States)
ATC codeN05AX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc114229197950500 TABLET, FILM COATED in 1 BOTTLE (42291-979-50)
- ndc11422919796060 TABLET, FILM COATED in 1 BOTTLE (42291-979-60)
Annotations
UNII (FDA Substance ID)
L6UH7ZF8HC
RISPERIDONE
RxCUI 35636
Orange Book
A078707
ABABABABABAB
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": "42291-979_3d4c5818-d71d-e4d0-e063-6394a90a9679",
"productndc": "42291-979",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078707",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.25MG",
"product_no": "001",
"approval_date": "Dec 29, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "002",
"approval_date": "Dec 29, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "003",
"approval_date": "Dec 29, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "004",
"approval_date": "Dec 29, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3MG",
"product_no": "005",
"approval_date": "Dec 29, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "4MG",
"product_no": "006",
"approval_date": "Dec 29, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RISPERIDONE",
"proprietary_name": "Risperidone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078707",
"marketing_category": "ANDA",
"nonproprietary_name": "Risperidone",
"start_marketing_date": "20250827",
"active_numerator_strength": "4"
}Related drugs
Other records sharing ATC code N05AX08.
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