United States· US:0409-3301_8d48de06-361f-418b-bfec-8ef85f94d5bc

Precedex

A medicinal product containing dexmedetomidine hydrochloride, registered in United States by Hospira, Inc..

US 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…normalisedPrecedexATC—REGISTER NO.US:0409-3301_8d48de06…PACKS LISTED1CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DEXMEDETOMIDINE HYDROCHLORIDE
Manufacturer
Hospira, Inc.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    0409330110
    10 VIAL in 1 CARTON (0409-3301-10) / 20 mL in 1 VIAL (0409-3301-01)

Regulatory notes

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

Same medicine, other countries

Dexmedetomidine hydrochloride in 15 other countries

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

All dexmedetomidine hydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 31 EEA countries. Names it is sold under:

  • Austria · Dexmedetomidin Altan, Dexmedetomidin Altan Pharmaceuticals, S.A.
  • Belgium · Dexmedetomidine A.Forall, Dexmedetomidine Baxter
  • Bulgaria · Dexmedetomidine Ever Valinject, Dexmedetomidine Kalceks
  • Cyprus · Dexmedetomidine Baxter, Dexmedetomidine Ever Valinject
  • Czechia · Dexmedetomidine B. Braun, Dexmedetomidine Ever Pharma
  • Germany · Dexmedetomidin B. Braun, Dexmedetomidin Baxter
  • Denmark · Dexmedetomidin Kalceks, Dexmedetomidin Viatris
  • Estonia · Dexmedetomidine Auxilia, Dexmedetomidine Kabi
  • Spain · Dexmedetomidina Altan, Dexmedetomidina B. Braun
  • Finland · Dexmedetomidine B. Braun, Dexmedetomidine Baxter
  • France · Dexmedetomidine Altan, Dexmedetomidine Ever Pharma
  • United Kingdom (Northern Ireland) · Dexmedetomidine 100 Micrograms/Ml Concentrate For Solution For Infusion, Dexmedetomidine Altan Pharma
  • Greece · Dexmedetomidine /Kabi, Dexmedetomidine Ariti
  • Croatia · Deksmedetomidin Kabi, Deksmedetomidin Kalceks
  • Hungary · Dexmedetomidin Ever Pharma, Dexmedetomidine Kabi
  • Ireland · Dexmedetomidine As Kalceks, Dexmedetomidine B. Braun
  • Iceland · Dexdor, Dexmedetomidine Rph Pharma
  • Italy · Dexmedetomidina Galenica Senese, Dexmedetomidina Hikma
  • Liechtenstein · Dexdor
  • Lithuania · Dexmedetomidine Kabi, Dexmedetomidine Kalceks
  • Luxembourg · Dexmedetomidine Baxter, Dexmedetomidine Kabi
  • Latvia · Dexmedetomidine Kalceks, Dexmedetomidine Pharmidea
  • Malta · Dexmedetomidine Ever Valinject
  • Netherlands · Dexmedetomidine Altan Pharmaceuticals, S.A., Dexmedetomidine B. Braun
  • Norway · Dexdor, Dexmedetomidine B. Braun
  • Poland · Dexmedetomidine Ever Pharma, Dexmedetomidine Farmak
  • Portugal · Dexmedetomidina A.Forall, Dexmedetomidina Acure
  • Romania · Dexmedetomidină Kabi, Dexmedetomidină Kalceks
  • Sweden · Dexmedetomidine B. Braun, Dexmedetomidine Baxter
  • Slovenia · Deksmedetomidin Kalceks, Deksmedetomidin Viatris
  • Slovakia · Dexmedetomidine B. Braun, Dexmedetomidine Ever Pharma

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/e29dc390-10b2-46db-b387-d219eea696a0
GET /v1/drugs/e29dc390-10b2-46db-b387-d219eea696a0?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",
  "productid": "0409-3301_8d48de06-361f-418b-bfec-8ef85f94d5bc",
  "productndc": "0409-3301",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXMEDETOMIDINE HYDROCHLORIDE",
  "proprietary_name": "Precedex",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA021038",
  "marketing_category": "NDA",
  "nonproprietary_name": "DEXMEDETOMIDINE HYDROCHLORIDE",
  "start_marketing_date": "20220307",
  "active_numerator_strength": "4"
}

See everything about dexmedetomidine hydrochloride.

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.