United States· US:63323-690_eeea4928-a68a-4552-836f-d819de9de1d4
Acetylcysteine
A medicinal product containing acetylcysteine, registered in United States by Fresenius Kabi USA, LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ACETYLCYSTEINE
- Manufacturer
- Fresenius Kabi USA, LLC
- 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
- ndc1163323-690-44
- ndc1163323690443 VIAL in 1 CARTON (63323-690-44) / 30 mL in 1 VIAL (63323-690-41)
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.
- United KingdomA-CYS 200mg granules sachetsEnnogen Healthcare International Ltd
- CzechiaACCHexal AG, Holzkirchen
- SwitzerlandACC Sandoz 200, Brausetabletten mit BrombeeraromaSandoz Pharmaceuticals AG
- SpainACETILCISTEINA ABEX 600 MG COMPRIMIDOS EFERVESCENTESKern Pharma S.L.
- BelgiumAcebloxus 200 mgSandoz
- NetherlandsAcetylcysteïne Alpex 200 mg, bruistablettenAlpex Pharma (IRL) Limited
- GermanyAccHexal Ag
- PolandACCDelfarma Sp. z o.o.
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/af1ccce5-cd05-4628-9630-3f9c1dbcb8a6 GET /v1/drugs/af1ccce5-cd05-4628-9630-3f9c1dbcb8a6?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": "200",
"substance": "ACETYLCYSTEINE",
"productndc": "63323-690",
"dosage_form": "SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA203853",
"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.