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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.

ATC H01CC01US 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…normalisedGanirelix AcetateATCH01CC01REGISTER NO.US:0548-5001_0e71b74d…PACKS LISTED2CHECKEDSeptember 27, 2026

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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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

  • ndc11
    0548-5001-00
  • ndc11
    0548500100
    1 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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All ganirelix products

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.