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United States · US · US:70121-2626_1109da94-12c2-4378-b9fb-74f94382b90a
Risperidone
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170121262651 KIT in 1 CARTON (70121-2626-5) * 2 mL in 1 SYRINGE (70121-2624-2) * 2 mL in 1 VIAL (70121-1351-1)
Annotations
Orange Book
A218586
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "INTRAMUSCULAR",
"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": "70121-2626_1109da94-12c2-4378-b9fb-74f94382b90a",
"productndc": "70121-2626",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "218586",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "12.5MG/VIAL",
"product_no": "001",
"approval_date": "Sep 2, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG/VIAL",
"product_no": "002",
"approval_date": "Sep 2, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "37.5MG/VIAL",
"product_no": "003",
"approval_date": "Sep 2, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG/VIAL",
"product_no": "004",
"approval_date": "Sep 2, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Risperidone",
"active_ingred_unit": null,
"application_number": "ANDA218586",
"marketing_category": "ANDA",
"nonproprietary_name": "risperidone",
"start_marketing_date": "20250908",
"active_numerator_strength": null
}Access this data programmatically
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