United States· US:0409-3307_6c12470d-0f1a-4085-938d-121df34c3cb0

Acetylcysteine

A medicinal product containing acetylcysteine, 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…normalisedAcetylcysteineATC—REGISTER NO.US:0409-3307_6c12470d…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ACETYLCYSTEINE
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
September 27, 2026

Packs & prices · 2

  • ndc11
    0409330703
    3 VIAL in 1 CARTON (0409-3307-03) / 30 mL in 1 VIAL (0409-3307-11)
  • ndc11
    0409-3307-03

Regulatory notes

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

Same medicine, other countries

Acetylcysteine in 15 other countries

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

All acetylcysteine products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Acetylcystein Hexal, Aeromuc
  • Belgium · Acetylcysteine Ab, Acetylcysteine Eg
  • Bulgaria · Aцц, Ацетилцистеин Ромфарм
  • Cyprus · Solmucol, Trebon-N
  • Czechia · Acc, Acc Neo
  • Germany · Acc, Acc Akut Hustenlöser
  • Denmark · Acetylcystein Pharmexon, Acetylcystein Sad
  • Estonia · Acc, Acc Long
  • Spain · Acetilcisteína Alter, Acetilcisteina Aristo
  • Finland · Acetylcysteine Macure, Bisolaclar
  • France · Acetylcysteine Alpex Adultes, Acetylcysteine Arrow
  • United Kingdom (Northern Ireland) · Acepiro, Acetylcysteine Aurum Pharmaceuticals
  • Greece · Fluimucil, Lilovon
  • Croatia · Fluimukan, Fluimukan Akut
  • Hungary · Acc, Acc Hot
  • Ireland · Acetylcysteine Essential-Healthcare Ascot Laboratories (Ireland) Limited, Nacsys
  • Iceland · Mucolysin, Mucomyst
  • Italy · Acc, Acc Fluidificante E Antidoto
  • Lithuania · Acc, Acc Long
  • Luxembourg · Acetylcysteine Eg, Exomuc
  • Latvia · Acc, Acc Hot
  • Malta · Fluimucil, Trebon-N Pd.Or.Sus
  • Netherlands · Acetylcysteïhe Sanias, Acetylcysteïne Alpex
  • Norway · Acetylcystein Sandoz, Acetylcysteine Macure
  • Poland · Acc, Acc Classic
  • Portugal · Acetilcisteína Alter, Acetilcisteina Azevedos
  • Romania · Acc, Acc Cu Aroma De Mure
  • Sweden · Acetylcystein 1a Farma, Acetylcystein Alternova
  • Slovenia · Acibel, Fluimukan
  • Slovakia · Acc, Acc Long

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/e9d335da-6fe1-48b1-bf25-4f6d629d5f38
GET /v1/drugs/e9d335da-6fe1-48b1-bf25-4f6d629d5f38?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; RESPIRATORY (INHALATION)",
  "source": "ndc",
  "strength": "100",
  "substance": "ACETYLCYSTEINE",
  "productndc": "0409-3307",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA073664",
  "marketing_category": "ANDA"
}

See everything about acetylcysteine.

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.