United States· US:0069-0106_d7eb51c8-fe18-46f2-8d97-eaa343ec8821

ELELYSO

A taliglucerase alfa product containing taliglucerase alfa, registered in United States by Pfizer Laboratories Div Pfizer Inc. The same ATC class is registered in 2 of our 19 countries.

ATC A16AB11US 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…normalisedELELYSOATCA16AB11REGISTER NO.US:0069-0106_d7eb51c8…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Taliglucerase alfa is registered in 2 of 19 countries.

Countries holding a registration under ATC A16AB11 (taliglucerase alfa), each read from that country’s own register.

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

Taliglucerase alfa · ATC A16AB11

2 / 19 countries

  • Canada
  • 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
TALIGLUCERASE ALFA
Manufacturer
Pfizer Laboratories Div Pfizer Inc
Country
United States (US)
ATC code
A16AB11
ATC class
Taliglucerase alfa
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    0069010601
    1 VIAL, GLASS in 1 CARTON (0069-0106-01) / 5 mL in 1 VIAL, GLASS
  • ndc11
    0069-0106-01

Regulatory notes

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

Same medicine, other countries

Taliglucerase alfa in 1 other country

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

All taliglucerase alfa products

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/4928203c-2193-4128-912b-5324f6fd9ab9
GET /v1/drugs/4928203c-2193-4128-912b-5324f6fd9ab9?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": "INTRAVENOUS",
  "source": "ndc",
  "strength": "200",
  "substance": "TALIGLUCERASE ALFA",
  "productndc": "0069-0106",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "strength_unit": "U/5mL",
  "application_number": "BLA022458",
  "marketing_category": "BLA"
}

See everything about taliglucerase alfa.

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.