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United States · US · US:50458-309_42dc490b-4117-142a-e063-6294a90aeb21
RISPERDAL CONSTA
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJanssen Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150458309111 KIT in 1 BOX (50458-309-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE (50458-309-01)
Annotations
Orange Book
N021346
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"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": "50458-309_42dc490b-4117-142a-e063-6294a90aeb21",
"productndc": "50458-309",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "021346",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "25MG/VIAL",
"product_no": "001",
"approval_date": "Oct 29, 2003"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "37.5MG/VIAL",
"product_no": "002",
"approval_date": "Oct 29, 2003"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "50MG/VIAL",
"product_no": "003",
"approval_date": "Oct 29, 2003"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "12.5MG/VIAL",
"product_no": "004",
"approval_date": "Apr 12, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "RISPERDAL CONSTA",
"active_ingred_unit": null,
"application_number": "NDA021346",
"marketing_category": "NDA",
"nonproprietary_name": "risperidone",
"start_marketing_date": "20031029",
"active_numerator_strength": null
}Access this data programmatically
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