cetrorelix acetate

Orange BookSPL

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808360001
1 TRAY in 1 CARTON (68083-600-01) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (68083-598-01) * 1 mL in 1 SYRINGE (68083-599-01)

Annotations

Orange Book

A218150

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "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": "68083-600_ab90e510-eecd-4d5f-b2df-059d3cbfc8f0",
  "productndc": "68083-600",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "218150",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.25MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Apr 25, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "cetrorelix acetate",
  "active_ingred_unit": null,
  "application_number": "ANDA218150",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cetrorelix acetate",
  "start_marketing_date": "20240425",
  "active_numerator_strength": null
}

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