United States· US:0548-5001_0e71b74d-723d-46a4-b2e5-7c7157949ad4
Ganirelix Acetate
A ganirelix product containing ganirelix acetate, registered in United States by Amphastar Pharmaceuticals, Inc.. The same ATC class is registered in 17 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Ganirelix is registered in 17 of 19 countries.
Countries holding a registration under ATC H01CC01 (ganirelix), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 10 of them publish a price we can compare per daily dose
Ganirelix · ATC H01CC01
17 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- Sweden
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- GANIRELIX ACETATE
- Manufacturer
- Amphastar Pharmaceuticals, Inc.
- Country
- United States (US)
- ATC code
- H01CC01
- ATC class
- Ganirelix
- Defined daily dose
- 0.25 mg, P
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc110548-5001-00
- ndc1105485001001 SYRINGE in 1 CARTON (0548-5001-00) / .5 mL in 1 SYRINGE
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
7 interactions on record for ganirelix.
Graded by severity as the source publishes them — 7 moderate. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Ganirelix · interactions on record
7 records
- 7 moderate
Most severe, free to view
- Chorionic gonadotrophinG03GA01moderate
- Menotropin HMGG03GA02moderate
- UrofollitropinG03GA04moderate
- GonadorelinH01CA01moderate
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Ganirelix in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainASTARTE 0,25 MG/0,5 ML SOLUCION INYECTABLE EN JERINGA PRECARGADA EFGGp Pharm S.A.
- FinlandFyremadelSun Pharmaceutical Industries Europe B.V.
- CzechiaGANIRELIX GEDEON RICHTERGedeon Richter Plc., Budapešť
- NetherlandsFyremadel, 0,25 mg/0,5 ml oplossing voor injectie in voorgevulde spuitSun Pharmaceutical Industries Europe B.V.
- United KingdomFyremadel 250micrograms/0.5ml solution for injection pre-filled syringesFerring Pharmaceuticals Ltd
- SwitzerlandGanirelix Labatec 0,25 mg, solution injectable en seringue préremplieLabatec Pharma SA
- FranceFYREMADEL 0,25 mg/0,5 mL, solution injectable en seringue pré-remplieSUN PHARMACEUTICAL INDUSTRIES EUROPE (PAYS BAS)
- BelgiumFyremadel 0.25 mg/0.5 mlSun Pharmaceutical Industries Europe
Authorised across Europe · EMA
The same active substance is authorised in 26 EEA countries. Names it is sold under:
- Austria · Ganirelix Astro, Ganirelix Theramex
- Belgium · Fyremadel, Ovamex
- Bulgaria · Ganirelix Theramex
- Czechia · Fyremadel
- Germany · Fyremadel, Ganiran
- Denmark · Fyremadel, Ganirelix Orifarm
- Estonia · Ganirelix Theramex
- Spain · Astarté, Fyremadel
- Finland · Fyremadel, Ganirelix Orifarm
- France · Fyremadel, Ganirelix Eg
- United Kingdom (Northern Ireland) · Fyremadel
- Greece · Fyremadel, Ovamex
- Croatia · Ganireliks Theramex
- Hungary · Ganirelix Theramex
- Iceland · Ganirelix, Ganirelix Gedeon Richter
- Italy · Fyremadel, Ovamex
- Liechtenstein · Ganirelix, Ganirelix Gedeon Richter
- Lithuania · Ganirelix Theramex
- Latvia · Ganirelix Theramex
- Netherlands · Fyremadel, Ganirelix Fagron
- Norway · Fyremadel, Ganirelix
- Poland · Fyremadel, Ovamex
- Portugal · Astarté, Fyremadel
- Sweden · Fyremadel, Ganirelix Orifarm
- Slovenia · Ganireliks Theramex
- Slovakia · Fyremadel, Ganirelix Theramex
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/c30aadd9-9404-4486-bb21-705cac150c60 GET /v1/drugs/c30aadd9-9404-4486-bb21-705cac150c60?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": "250",
"substance": "GANIRELIX ACETATE",
"productndc": "0548-5001",
"dosage_form": "INJECTION",
"dea_schedule": null,
"strength_unit": "ug/.5mL",
"application_number": "ANDA212613",
"marketing_category": "ANDA"
}See everything about ganirelix.
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.