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United States · US · US:73606-010_0a1c9d84-182a-4e4c-8adf-74a3ca2db038

Empaveli

Orange BookUNIISPLATC L04AJ03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerApellis Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL04AJ03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7360601001
    1 VIAL in 1 CARTON (73606-010-01) / 20 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
TO3JYR3BOU
PEGCETACOPLAN
RxCUI 2557372
Orange Book
N215014
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "TO3JYR3BOU",
    "rxcui": "2557372",
    "inchikey": null,
    "display_name": "PEGCETACOPLAN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "c23d89e9-b00b-4520-e053-2995a90a95af": {
      "match": "brand_token",
      "title": "EMPAVELI (PEGCETACOPLAN) INJECTION, SOLUTION [APELLIS PHARMACEUTICALS, INC.]",
      "spl_version": "13",
      "published_date": "2025-08-04"
    }
  },
  "productid": "73606-010_0a1c9d84-182a-4e4c-8adf-74a3ca2db038",
  "productndc": "73606-010",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215014",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1080MG/20ML (54MG/ML)",
        "product_no": "001",
        "approval_date": "May 14, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PEGCETACOPLAN",
  "proprietary_name": "Empaveli",
  "active_ingred_unit": "mg/20mL",
  "application_number": "NDA215014",
  "marketing_category": "NDA",
  "nonproprietary_name": "Pegcetacoplan",
  "start_marketing_date": "20210514",
  "active_numerator_strength": "1080"
}

Related drugs

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