United States· US:71288-569_fed2b538-4e01-4e4b-9e92-1750554aba61

Leuprolide Acetate

A medicinal product containing leuprolide acetate, registered in United States by Meitheal Pharmaceuticals Inc.

Orange BookUS label

Checked against FDA National Drug Code directory (United States) on September 12, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: Leuprolide Acetate
Manufacturer: Meitheal Pharmaceuticals Inc
Country: United States (US)
ATC code: —
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: September 12, 2026

Packs & prices · 1

ndc11
7128856990
1 KIT in 1 CARTON (71288-569-90) * 1 VIAL, MULTI-DOSE in 1 CARTON (71288-565-03) / 2.8 mL in 1 VIAL, MULTI-DOSE * .5 mL in 1 PACKET (71288-350-91)

Regulatory notes

Orange Book

A075471

DailyMed SPL labels

1 version tracked

Same medicine, other countries

Leuprolide acetate in 17 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All leuprolide acetate products

Authorised across Europe · EMA

The same active substance is authorised in 31 EEA countries. Names it is sold under:

Austria · Eligard Depot, Enantone Monats-Depot
Belgium · Depo-Eligard
Bulgaria · Елигард, Лутрат Депо
Cyprus · Eligard
Czechia · Eligard, Leptoprol
Germany · Eligard, Enantone Monats-Depot
Denmark · Eligard, Leuprorelin Sandoz
Estonia · Eligard
Spain · Eligard Semestral, Eligard Trimestral
Finland · Eligard, Enanton Depot Dual
France · Eligard, Enantone Lp
United Kingdom (Northern Ireland) · Prostap 3 Dcs, Prostap Pd Dcs
Greece · Deplanda, Elityran
Croatia · Eligard, Lerin
Hungary · Eligard, Leuprorelin Pharmacenter
Ireland · Eligard, Leuprex 3
Iceland · Camcevi, Eligard
Italy · Eligard, Enantone
Liechtenstein · Camcevi
Lithuania · Eligard
Luxembourg · Depo-Eligard, Leugon
Latvia · Eligard, Leptoprol
Malta · Deplanda
Netherlands · Eligard, Leuproreline Sandoz
Norway · Camcevi, Eligard
Poland · Eligard, Leuprostin
Portugal · Eligard, Lutrate Depot
Romania · Eligard, Leptoprol
Sweden · Eligard, Enanton Depot Dual
Slovenia · Eligard, Leptoprol
Slovakia · Eligard, Leuprorelin Sandoz

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload

GET /v1/drugs/f9277d32-c394-4d31-8af2-fa41352025b4
GET /v1/drugs/f9277d32-c394-4d31-8af2-fa41352025b4?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "SUBCUTANEOUS",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "35634415-000f-47db-9bd7-9e16eef3f02e": {
      "match": "brand_token",
      "title": "LEUPROLIDE ACETATE (LEUPROLIDE ACETATE) KIT [ZYDUS PHARMACEUTICALS USA INC.]",
      "spl_version": "6",
      "published_date": "2026-05-28"
    }
  },
  "productid": "71288-569_fed2b538-4e01-4e4b-9e92-1750554aba61",
  "productndc": "71288-569",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "075471",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "14MG/2.8ML (1MG/0.2ML)",
        "product_no": "001",
        "approval_date": "Oct 25, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Leuprolide Acetate",
  "active_ingred_unit": null,
  "application_number": "ANDA075471",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Leuprolide Acetate",
  "start_marketing_date": "20240515",
  "active_numerator_strength": null
}

API reference MCP server Plans

See everything about leuprolide acetate.

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