United States· US:10122-210_8b236f4c-7654-49fe-bca9-ab947b72a1fd

Myalept

A metreleptin product containing metreleptin, registered in United States by Chiesi USA, Inc.. The same ATC class is registered in 12 of our 19 countries.

ATC A16AA07US 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…normalisedMyaleptATCA16AA07REGISTER NO.US:10122-210_8b236f4c…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Metreleptin is registered in 12 of 19 countries.

Countries holding a registration under ATC A16AA07 (metreleptin), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 8 of them publish a price we can compare per daily dose

Metreleptin · ATC A16AA07

12 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • 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
METRELEPTIN
Manufacturer
Chiesi USA, Inc.
Country
United States (US)
ATC code
A16AA07
ATC class
Metreleptin
Defined daily dose
5 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
    1012221002
    1 VIAL, GLASS in 1 CARTON (10122-210-02) / 2.2 mL in 1 VIAL, GLASS
  • ndc11
    10122-210-02

Regulatory notes

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

Interactions

193 interactions on record for metreleptin.

Graded by severity as the source publishes them — 1 severe. 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

Metreleptin · interactions on record

193 records

  • 1 severe
  • 188 moderate
  • 4 minor

Most severe, free to view

  • RolapitantA04AD14moderate
  • NaloxegolA06AH03moderate
  • Insulin (human)A10AB01moderate
  • Insulin lisproA10AB04moderate
  • 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

Metreleptin in 14 other countries

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

All metreleptin products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Myalepta
  • Liechtenstein · Myalepta
  • Norway · Myalepta

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/83cb7f5b-3880-4f0d-b64b-073ad8db4c38
GET /v1/drugs/83cb7f5b-3880-4f0d-b64b-073ad8db4c38?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": "11.3",
  "substance": "METRELEPTIN",
  "productndc": "10122-210",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/2.2mL",
  "application_number": "BLA125390",
  "marketing_category": "BLA"
}

See everything about metreleptin.

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.