Erzofri extended-release

Orange BookUNIISPLATC N05AX13

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

Identification

ManufacturerShandong Luye Pharmaceutical Co., Ltd.

CountryUS (United States)

ATC codeN05AX13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7252610611
1 SYRINGE, GLASS in 1 KIT (72526-106-11) / .5 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)

R8P8USM8FR

PALIPERIDONE PALMITATE

RxCUI 858045

Orange Book

N216352

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": {
    "492bf9dd-868e-421a-92db-8cca8973aac1": {
      "match": "brand_token",
      "title": "ERZOFRI EXTENDED-RELEASE (PALIPERIDONE PALMITATE) INJECTION [SHANDONG LUYE PHARMACEUTICAL CO., LTD.]",
      "spl_version": "7",
      "published_date": "2026-03-10"
    }
  },
  "productid": "72526-106_4c9a70a9-b1b5-b462-e063-6294a90adefd",
  "productndc": "72526-106",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216352",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "39MG/0.25ML (39MG/0.25ML)",
        "product_no": "001",
        "approval_date": "Jul 26, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "78MG/0.5ML (78MG/0.5ML)",
        "product_no": "002",
        "approval_date": "Jul 26, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "117MG/0.75ML (117MG/0.75ML)",
        "product_no": "003",
        "approval_date": "Jul 26, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "156MG/ML (156MG/ML)",
        "product_no": "004",
        "approval_date": "Jul 26, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "234MG/1.5ML (156MG/ML)",
        "product_no": "005",
        "approval_date": "Jul 26, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "351MG/2.25ML (156MG/ML)",
        "product_no": "006",
        "approval_date": "Jul 26, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PALIPERIDONE PALMITATE",
  "proprietary_name": "Erzofri extended-release",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "NDA216352",
  "marketing_category": "NDA",
  "nonproprietary_name": "paliperidone palmitate",
  "start_marketing_date": "20241210",
  "active_numerator_strength": "78"
}

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