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United States · US · US:62559-981_2c44590a-6811-49fb-8cef-de7dc5bc6164
Risperidone
Orange BookUNIISPLATC N05AX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05AX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11625599813030 mL in 1 BOTTLE (62559-981-30)
Annotations
UNII (FDA Substance ID)
L6UH7ZF8HC
RISPERIDONE
RxCUI 35636
Orange Book
A076440
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": "62559-981_2c44590a-6811-49fb-8cef-de7dc5bc6164",
"productndc": "62559-981",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "076440",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Jan 30, 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": "ANDA076440",
"marketing_category": "ANDA",
"nonproprietary_name": "Risperidone",
"start_marketing_date": "20251027",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code N05AX08.
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