Cetrotide

Orange BookSPL

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

Identification

ManufacturerEMD Serono, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4408712251
1 KIT in 1 CARTON (44087-1225-1) * 1 mL in 1 VIAL, GLASS * 1 mL in 1 SYRINGE, GLASS

Annotations

Orange Book

N021197

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "aca7768e-28a7-4027-b1d8-e66247665f79": {
      "match": "brand_token",
      "title": "CETROTIDE (CETRORELIX ACETATE) KIT [EMD SERONO, INC.]",
      "spl_version": "18",
      "published_date": "2025-09-29"
    }
  },
  "productid": "44087-1225_716029d9-4462-4732-846c-456e74363b83",
  "productndc": "44087-1225",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "021197",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 0.25MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Aug 11, 2000"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 3MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Aug 11, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Cetrotide",
  "active_ingred_unit": null,
  "application_number": "NDA021197",
  "marketing_category": "NDA",
  "nonproprietary_name": "cetrorelix acetate",
  "start_marketing_date": "20000811",
  "active_numerator_strength": null
}

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