FDA — authorised 30 April 1992
- Application: ANDA072324
- Marketing authorisation holder: ROXANE
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
🇺🇸 N-acetylcysteine NAC in United States
FDA authorised N-acetylcysteine NAC on 30 April 1992 · 7 US adverse-event reports
Marketing authorisations
FDA — authorised 30 April 1992
- Application: ANDA072323
- Marketing authorisation holder: ROXANE
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA — authorised 30 September 1992
- Application: ANDA072621
- Marketing authorisation holder: ROXANE
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA — authorised 30 September 1992
- Application: ANDA072622
- Marketing authorisation holder: ROXANE
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA — authorised 30 August 1994
- Application: ANDA074037
- Marketing authorisation holder: HOSPIRA
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA — authorised 30 August 1994
- Application: ANDA073664
- Marketing authorisation holder: HOSPIRA
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA — authorised 28 July 1995
- Application: ANDA072489
- Marketing authorisation holder: AM REGENT
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA — authorised 28 July 1995
- Application: ANDA072547
- Marketing authorisation holder: AM REGENT
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA — authorised 13 March 1998
- Application: ANDA071364
- Marketing authorisation holder: HOSPIRA
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA — authorised 13 March 1998
- Application: ANDA071365
- Marketing authorisation holder: HOSPIRA
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA — authorised 21 June 2012
- Application: ANDA203853
- Marketing authorisation holder: ALVOGEN
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA — authorised 11 February 2014
- Application: ANDA204674
- Marketing authorisation holder: ALVOGEN
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA — authorised 24 March 2015
- Application: ANDA203173
- Marketing authorisation holder: RISING
- Local brand name: ACETYLCYSTEINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 29 January 2016
- Application: NDA207916
- Marketing authorisation holder: ARBOR PHARMS LLC
- Local brand name: CETYLEV
- Indication: TABLET, EFFERVESCENT — ORAL
- Status: approved
FDA — authorised 29 February 2016
- Application: ANDA207358
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: ACETYLCYSTEINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 31 October 2017
- Application: ANDA091684
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: ACETYLCYSTEINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 21 August 2019
- Application: ANDA203624
- Marketing authorisation holder: RISING
- Local brand name: ACETYLCYSTEINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 15 April 2021
- Application: ANDA204797
- Marketing authorisation holder: EXELA PHARMA
- Local brand name: ACETYLCYSTEINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 3 February 2022
- Application: ANDA213693
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: ACETYLCYSTEINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 February 2022
- Application: ANDA215620
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: ACETYLCYSTEINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 April 2023
- Application: ANDA217182
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: ACETYLCYSTEINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 1 November 2023
- Application: ANDA205643
- Marketing authorisation holder: EXELA PHARMA
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA — authorised 7 June 2024
- Application: ANDA218397
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: ACETYLCYSTEINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 12 February 2025
- Application: ANDA219194
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA — authorised 14 March 2025
- Application: ANDA214177
- Marketing authorisation holder: CONBA USA
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA
- Application: ANDA071741
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: ACETYLCYSTEINE
- Indication: Solution — Inhalation, Oral
- Status: approved
FDA
- Application: ANDA071740
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: ACETYLCYSTEINE
- Indication: Solution — Inhalation, Oral
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 7
Most-reported reactions
- Blood Glucose Increased — 1 report (14.29%)
- Drug Ineffective — 1 report (14.29%)
- Drug Ineffective For Unapproved Indication — 1 report (14.29%)
- Hyperglycaemia — 1 report (14.29%)
- Intestinal Obstruction — 1 report (14.29%)
- Product Quality Issue — 1 report (14.29%)
- Sepsis — 1 report (14.29%)
N-acetylcysteine NAC in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is N-acetylcysteine NAC approved in United States?
Yes. FDA authorised it on 30 April 1992; FDA authorised it on 30 April 1992; FDA authorised it on 30 September 1992.
Who is the marketing authorisation holder for N-acetylcysteine NAC in United States?
ROXANE holds the US marketing authorisation.