INVEGA SUSTENNA

Orange BookUNIISPLATC N05AX13

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerJanssen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN05AX13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5045856001
1 SYRINGE in 1 KIT (50458-560-01) / .25 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

R8P8USM8FR

PALIPERIDONE PALMITATE

RxCUI 858045

Orange Book

N022264

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "R8P8USM8FR",
    "rxcui": "858045",
    "inchikey": "VOMKSBFLAZZBOW-UHFFFAOYSA-N",
    "display_name": "PALIPERIDONE PALMITATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "7b8e5b26-b9e4-4704-921b-3c3c0d159916": {
      "match": "brand_token",
      "title": "INVEGA (PALIPERIDONE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]",
      "spl_version": "43",
      "published_date": "2026-03-20"
    }
  },
  "productid": "50458-560_2e1c43cb-d27e-b3ac-e063-6394a90ad44a",
  "productndc": "50458-560",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "022264",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "39MG/0.25ML (39MG/0.25ML)",
        "product_no": "001",
        "approval_date": "Jul 31, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "78MG/0.5ML (78MG/0.5ML)",
        "product_no": "002",
        "approval_date": "Jul 31, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "117MG/0.75ML (117MG/0.75ML)",
        "product_no": "003",
        "approval_date": "Jul 31, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "156MG/ML (156MG/ML)",
        "product_no": "004",
        "approval_date": "Jul 31, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "234MG/1.5ML (156MG/ML)",
        "product_no": "005",
        "approval_date": "Jul 31, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PALIPERIDONE PALMITATE",
  "proprietary_name": "INVEGA SUSTENNA",
  "active_ingred_unit": "mg/.25mL",
  "application_number": "NDA022264",
  "marketing_category": "NDA",
  "nonproprietary_name": "paliperidone palmitate",
  "start_marketing_date": "20090731",
  "active_numerator_strength": "39"
}

Related drugs

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