FDA — authorised 30 September 1992
- Application: ANDA072621
- Marketing authorisation holder: ROXANE
- Local brand name: ACETYLCYSTEINE
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
🇺🇸 NAC in United States
FDA authorised NAC on 30 September 1992 · 1,039 US adverse-event reports
Marketing authorisations
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: 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: ANDA071365
- Marketing authorisation holder: HOSPIRA
- 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 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 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 23 February 2022
- Application: ANDA215620
- Marketing authorisation holder: REGCON HOLDINGS
- 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
- Application: ANDA071740
- Marketing authorisation holder: QUAD PHARMS
- 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
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: 22 April 2025 – 22 April 2026
- Total reports: 1,039
Most-reported reactions
- Fatigue — 163 reports (15.69%)
- Nausea — 123 reports (11.84%)
- Headache — 117 reports (11.26%)
- Dyspnoea — 114 reports (10.97%)
- Diarrhoea — 103 reports (9.91%)
- Pain — 96 reports (9.24%)
- Dizziness — 95 reports (9.14%)
- Arthralgia — 79 reports (7.6%)
- Drug Ineffective — 77 reports (7.41%)
- Asthenia — 72 reports (6.93%)
Frequently asked questions
Is NAC approved in United States?
Yes. FDA authorised it on 30 September 1992; FDA authorised it on 30 September 1992; FDA authorised it on 30 August 1994.
Who is the marketing authorisation holder for NAC in United States?
ROXANE holds the US marketing authorisation.