Cetrorelix Acetate

Orange BookSPL

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7128855890
1 KIT in 1 CARTON (71288-558-90) * 2 mL in 1 VIAL, SINGLE-DOSE (71288-556-02) * 1 mL in 1 SYRINGE, GLASS (71288-557-81)

Annotations

Orange Book

A214540

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": "71288-558_1f143808-6446-45a1-9a8c-9e58a26c22cb",
  "productndc": "71288-558",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "214540",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.25MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Apr 24, 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": "ANDA214540",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetrorelix Acetate",
  "start_marketing_date": "20240424",
  "active_numerator_strength": null
}

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