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United States · US · US:63304-643_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 · 4
- ndc116330464305500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-643-05)
- ndc11633046431710 POUCH in 1 BOX, UNIT-DOSE (63304-643-17) / 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-643-11)
- ndc11633046433030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-643-30)
- ndc1163304643691 BLISTER PACK in 1 CARTON (63304-643-69) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
L6UH7ZF8HC
RISPERIDONE
RxCUI 35636
Orange Book
A078474
ABAB
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": "63304-643_8c155c45-e5c8-4358-90da-8f6d193ad88b",
"productndc": "63304-643",
"dosage_form": "TABLET, ORALLY DISINTEGRATING",
"orange_book": {
"appl_no": "078474",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3MG",
"product_no": "001",
"approval_date": "Aug 6, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "4MG",
"product_no": "002",
"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": "ANDA078474",
"marketing_category": "ANDA",
"nonproprietary_name": "Risperidone",
"start_marketing_date": "20100806",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code N05AX08.
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