Cetrorelix

Orange BookSPL

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

Identification

ManufacturerTeva Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0480579508
1 TRAY in 1 CARTON (0480-5795-08) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (0480-3583-01) * 1 mL in 1 SYRINGE (0480-3584-21)

Annotations

Orange Book

A215737

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "f91c971b-89d7-4306-966d-8ecc1afc16d1": {
      "match": "brand_token",
      "title": "CETRORELIX (CETRORELIX ACETATE) KIT [TEVA PHARMACEUTICALS, INC.]",
      "spl_version": "6",
      "published_date": "2025-08-11"
    }
  },
  "productid": "0480-5795_f8c62e7c-4615-463b-af59-b820a9e3b911",
  "productndc": "0480-5795",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "215737",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.25MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Aug 12, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Cetrorelix",
  "active_ingred_unit": null,
  "application_number": "ANDA215737",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetrorelix Acetate",
  "start_marketing_date": "20231214",
  "active_numerator_strength": null
}

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