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United States · US · US:50458-305_408e48a3-35fc-49e1-8e01-44305d9083a4
RISPERDAL
Orange BookUNIISPLATC N05AX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJanssen Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05AX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11504583050330 mL in 1 BOTTLE (50458-305-03)
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": {
"bb34ee82-d2c2-43b8-ba21-2825c0954691": {
"match": "brand_token",
"title": "RISPERDAL CONSTA (RISPERIDONE) KIT [JANSSEN PHARMACEUTICALS, INC.]",
"spl_version": "38",
"published_date": "2025-11-17"
}
},
"productid": "50458-305_408e48a3-35fc-49e1-8e01-44305d9083a4",
"productndc": "50458-305",
"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": "RISPERDAL",
"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.
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