FIRMAGON

Orange BookSPL

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

Identification

ManufacturerFerring Pharmaceuticals Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5556684031
1 KIT in 1 CARTON (55566-8403-1) * 3 mL in 1 SYRINGE * 3 mL in 1 VIAL, GLASS

Annotations

Orange Book

N022201

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "ab11dd8a-0fd9-4013-89ab-e114557c7e4b": {
      "match": "brand_token",
      "title": "FIRMAGON (DEGARELIX) KIT [FERRING PHARMACEUTICALS INC.]",
      "spl_version": "18",
      "published_date": "2024-02-01"
    }
  },
  "productid": "55566-8403_4c6e7e6f-aadd-45b1-baed-970b24766bf3",
  "productndc": "55566-8403",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "022201",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 80MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Dec 24, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 120MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Dec 24, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "FIRMAGON",
  "active_ingred_unit": null,
  "application_number": "NDA022201",
  "marketing_category": "NDA",
  "nonproprietary_name": "Degarelix",
  "start_marketing_date": "20090302",
  "active_numerator_strength": null
}

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