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United States · US · US:12496-0090_2893c2b5-aa3e-4ec7-bfd3-0132306a31a9
PERSERIS
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIndivior Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1112496009011 KIT in 1 CARTON (12496-0090-1) * 1 SYRINGE in 1 POUCH (12496-0090-2) / 1.2 mL in 1 SYRINGE (12496-0090-5) * 1 SYRINGE in 1 POUCH (12496-0589-2) / 1 mL in 1 SYRINGE (12496-0589-5)
- ndc1112496009091 KIT in 1 CARTON (12496-0090-9) * 1 SYRINGE in 1 POUCH (12496-0090-2) / 1.2 mL in 1 SYRINGE (12496-0090-5) * 1 SYRINGE in 1 POUCH (12496-0589-2) / 1 mL in 1 SYRINGE (12496-0589-5)
Annotations
Orange Book
N210655
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "SUBCUTANEOUS",
"spl_meta": {
"a4f21b1a-5691-4b14-a56d-651962d06f39": {
"match": "brand_token",
"title": "PERSERIS (RISPERIDONE) KIT [INDIVIOR INC.]",
"spl_version": "18",
"published_date": "2025-02-21"
}
},
"productid": "12496-0090_2893c2b5-aa3e-4ec7-bfd3-0132306a31a9",
"productndc": "12496-0090",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "210655",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "90MG",
"product_no": "001",
"approval_date": "Jul 27, 2018"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "120MG",
"product_no": "002",
"approval_date": "Jul 27, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "PERSERIS",
"active_ingred_unit": null,
"application_number": "NDA210655",
"marketing_category": "NDA",
"nonproprietary_name": "Risperidone",
"start_marketing_date": "20181109",
"active_numerator_strength": null
}Access this data programmatically
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