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United States· US:83634-454_9ad77738-6d76-4efb-96af-e9848794b07a

Leuprolide Acetate

A medicinal product, registered in United States by Avenacy, LLC.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedLeuprolide AcetateATC—REGISTER NO.US:83634-454_9ad77738…PACKS LISTED2CHECKEDJune 26, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Manufacturer
Avenacy, LLC
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 26, 2026

Packs & prices · 2

  • ndc11
    8363445461
    1 KIT in 1 CARTON (83634-454-61) * 2.8 mL in 1 VIAL, MULTI-DOSE (83634-452-03) * 1 mL in 1 PACKET (83634-453-01)
  • ndc11
    83634-454-61

Regulatory notes

No shortage, Orange Book or US label notes for this record.

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/be90678a-698b-49ab-aa80-f452cd7f8c24
GET /v1/drugs/be90678a-698b-49ab-aa80-f452cd7f8c24?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",
  "source": "ndc",
  "strength": null,
  "substance": null,
  "productndc": "83634-454",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "strength_unit": null,
  "application_number": "ANDA217957",
  "marketing_category": "ANDA"
}

See everything about Leuprolide.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.