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United States· US:71863-114_ce6d0fd4-bbe0-4a22-bfb5-33326b63a67f

Carglumic Acid

A carglumic acid product containing carglumic acid, registered in United States by Eton Pharmaceuticals, Inc.. The same ATC class is registered in 16 of our 19 countries.

ATC A16AA05US 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…normalisedCarglumic AcidATCA16AA05REGISTER NO.US:71863-114_ce6d0fd4…PACKS LISTED2CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about carglumic acidAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Carglumic acid is registered in 16 of 19 countries.

Countries holding a registration under ATC A16AA05 (carglumic acid), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 9 of them publish a price we can compare per daily dose
Search carglumic acid products by name

Carglumic acid · ATC A16AA05

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • 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.

Price per daily dose

What a daily dose of carglumic acid costs, country by country.

Normalised to the WHO defined daily dose (0.2 g), so markets compare like for like.

  • 1 market with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown
Open the full comparison — free accountDrug prices for market access

Carglumic acid · price per daily dose (0.2 g)

USD · FX 28 Sept 2026

  • IT Italy$92.77
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
CARGLUMIC ACID
Manufacturer
Eton Pharmaceuticals, Inc.
Country
United States (US)
ATC code
A16AA05
ATC class
Carglumic acid
Defined daily dose
0.2 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    7186311460
    1 BOTTLE in 1 CARTON (71863-114-60) / 60 TABLET, FOR SUSPENSION in 1 BOTTLE
  • ndc11
    71863-114-60

Regulatory notes

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

Same medicine, other countries

Carglumic acid in 17 other countries

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

All carglumic acid products

Authorised across Europe · EMA

The same active substance is authorised in 17 EEA countries. Names it is sold under:

  • Austria · Carglumsäure Waymade
  • Czechia · Carglumic Acid
  • Germany · Carglumsäure Waymade, Carglumsäure Zentiva
  • Denmark · Cargluminsyre
  • Spain · Ácido Carglúmico, Ácido Carglúmico Tillomed
  • Finland · Karglumiinihappo Waymade
  • France · Acide Carglumique Tillomed, Acide Carglumique Waymade
  • United Kingdom (Northern Ireland) · Carglumic Acid Waymade
  • Greece · Carglumic Acid, Carglumic Acid Tillomed
  • Iceland · Carbaglu, Ucedane
  • Italy · Acido Carglumico Waymade
  • Liechtenstein · Carbaglu, Ucedane
  • Netherlands · Carglumaatzuur Tillomed, Carglumaatzuur Waymade
  • Norway · Carbaglu, Kargluminsyre Waymade
  • Poland · Kwas Kargluminowy
  • Portugal · Ácido Carglúmico, Ácido Carglúmico Waymade
  • Sweden · Kargluminsyra Waymade

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/cdb2f8e1-062c-4655-8cc9-322199906d1f
GET /v1/drugs/cdb2f8e1-062c-4655-8cc9-322199906d1f?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": "ORAL",
  "source": "ndc",
  "strength": "200",
  "substance": "CARGLUMIC ACID",
  "productndc": "71863-114",
  "dosage_form": "TABLET, FOR SUSPENSION",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA213729",
  "marketing_category": "ANDA"
}
API referenceMCP serverPlans

See everything about carglumic acid.

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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