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United States · US · US:73606-020_76e1d7d9-903f-49c1-be3a-617f682e79e7

Syfovre

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 · 4

  • ndc11
    7360602001
    1 VIAL, GLASS in 1 CARTON (73606-020-01) / 3 mL in 1 VIAL, GLASS
  • ndc11
    7360602002
    1 VIAL, GLASS in 1 CARTON (73606-020-02) / 3 mL in 1 VIAL, GLASS
  • ndc11
    7360602011
    1 VIAL, GLASS in 1 CARTON (73606-020-11) / 3 mL in 1 VIAL, GLASS
  • ndc11
    7360602012
    1 VIAL, GLASS in 1 CARTON (73606-020-12) / 3 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
TO3JYR3BOU
PEGCETACOPLAN
RxCUI 2557372
Orange Book
N217171
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": "INTRAVITREAL",
  "spl_meta": {
    "b4434e61-9ec9-4e0e-bd60-45aaa0a87e64": {
      "match": "brand_token",
      "title": "SYFOVRE (PEGCETACOPLAN) INJECTION, SOLUTION [APELLIS PHARMACEUTICALS, INC.]",
      "spl_version": "12",
      "published_date": "2025-09-19"
    }
  },
  "productid": "73606-020_76e1d7d9-903f-49c1-be3a-617f682e79e7",
  "productndc": "73606-020",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "217171",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "15MG/0.1ML (15MG/0.1ML)",
        "product_no": "001",
        "approval_date": "Feb 17, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PEGCETACOPLAN",
  "proprietary_name": "Syfovre",
  "active_ingred_unit": "mg/.1mL",
  "application_number": "NDA217171",
  "marketing_category": "NDA",
  "nonproprietary_name": "Pegcetacoplan",
  "start_marketing_date": "20230217",
  "active_numerator_strength": "15"
}

Related drugs

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