United States· US:62935-163_6ad49800-db23-42bb-8543-1bbb6a9c96f2

Fensolvi

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

US label

Checked against FDA National Drug Code directory (United States) on September 27, 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: TOLMAR 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 27, 2026

Packs & prices · 2

ndc11
62935-163-60
ndc11
6293516360
1 SYRINGE in 1 CARTON (62935-163-60) / .375 mL in 1 SYRINGE

Regulatory notes

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

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/b3eabc52-e7e1-4792-805f-4bc7f89e8732
GET /v1/drugs/b3eabc52-e7e1-4792-805f-4bc7f89e8732?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": "45",
  "substance": "LEUPROLIDE ACETATE",
  "productndc": "62935-163",
  "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE",
  "dea_schedule": null,
  "strength_unit": "mg/.375mL",
  "application_number": "NDA213150",
  "marketing_category": "NDA"
}

API reference MCP server Plans

See everything about leuprolide acetate.

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.

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