INVEGA HAFYERA

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
5045861101
1 SYRINGE in 1 CARTON (50458-611-01) / 3.5 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

R8P8USM8FR

PALIPERIDONE PALMITATE

RxCUI 858045

Orange Book

N207946

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": "50458-611_2e6ef0e1-19d2-7d78-e063-6394a90ae8a6",
  "productndc": "50458-611",
  "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "207946",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "273MG/0.875ML (273MG/0.875ML)",
        "product_no": "001",
        "approval_date": "May 18, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "410MG/1.315ML (311.79MG/ML)",
        "product_no": "002",
        "approval_date": "May 18, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "546MG/1.75ML (312MG/ML)",
        "product_no": "003",
        "approval_date": "May 18, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "819MG/2.625ML (312MG/ML)",
        "product_no": "004",
        "approval_date": "May 18, 2015"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.092GM/3.5ML (312MG/ML)",
        "product_no": "005",
        "approval_date": "Aug 30, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.560GM/5ML (312MG/ML)",
        "product_no": "006",
        "approval_date": "Aug 30, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PALIPERIDONE PALMITATE",
  "proprietary_name": "INVEGA HAFYERA",
  "active_ingred_unit": "mg/3.5mL",
  "application_number": "NDA207946",
  "marketing_category": "NDA",
  "nonproprietary_name": "paliperidone palmitate",
  "start_marketing_date": "20210830",
  "active_numerator_strength": "1092"
}

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