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United States · US · US:63304-949_8c155c45-e5c8-4358-90da-8f6d193ad88b
Risperidone
Orange BookUNIISPLATC N05AX08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN05AX08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116330494905500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-949-05)
- ndc11633049491710 POUCH in 1 BOX, UNIT-DOSE (63304-949-17) / 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-949-11)
- ndc11633049493030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-949-30)
Annotations
UNII (FDA Substance ID)
L6UH7ZF8HC
RISPERIDONE
RxCUI 35636
Orange Book
A077542
ABABAB
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": "63304-949_8c155c45-e5c8-4358-90da-8f6d193ad88b",
"productndc": "63304-949",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "077542",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Aug 6, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "002",
"approval_date": "Aug 6, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "003",
"approval_date": "Aug 6, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RISPERIDONE",
"proprietary_name": "Risperidone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077542",
"marketing_category": "ANDA",
"nonproprietary_name": "Risperidone",
"start_marketing_date": "20100806",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code N05AX08.
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