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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

  • ndc11
    1249600901
    1 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)
  • ndc11
    1249600909
    1 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
}

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