🇺🇸
United States · US · US:65862-167_95217dea-1f5b-4645-b55f-09a5d0e6960e
RISPERIDONE
Orange BookUNIISPLATC N05AX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN05AX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1165862167011 BOTTLE in 1 CARTON (65862-167-01) / 30 mL in 1 BOTTLE
- ndc1165862167301 BOTTLE, GLASS in 1 CARTON (65862-167-30) / 30 mL in 1 BOTTLE, GLASS
Annotations
UNII (FDA Substance ID)
L6UH7ZF8HC
RISPERIDONE
RxCUI 35636
Orange Book
A078452
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": "65862-167_95217dea-1f5b-4645-b55f-09a5d0e6960e",
"productndc": "65862-167",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "078452",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Sep 4, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RISPERIDONE",
"proprietary_name": "RISPERIDONE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA078452",
"marketing_category": "ANDA",
"nonproprietary_name": "RISPERIDONE",
"start_marketing_date": "20190325",
"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.