Acetylcysteine
Acetadote, Acetylcysteine (acetylcysteine) is a small molecule pharmaceutical. Acetylcysteine was first approved as Mucomyst on 1982-01-01. It is used to treat amyloidosis, bronchiectasis, bronchitis, cystic fibrosis, and pneumonia amongst others in the USA.
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Acetadote, Acetylcysteine (discontinued: Acetylcysteine, Cetylev, Mucomyst, Mucosil)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Acetylcysteine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ACETADOTE | Cumberland Pharmaceuticals | N-021539 RX | 2004-01-23 | 1 products, RLD, RS |
Show 2 discontinued
Acetylcysteine
+
Isoproterenol hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MUCOMYST W/ ISOPROTERENOL | Mead Johnson Nutrition | N-017366 DISCN | 1982-01-01 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acetadote | New Drug Application | 2025-04-30 |
| acetylcysteine | ANDA | 2025-05-29 |
| antiseptic cleansing wipe(0.9% nacl) | C200263 | 2025-04-28 |
| disinfectant(naclo) | unapproved drug other | 2020-04-18 |
| esika natural care concha de nacar and rosa mosqueta facial fps 15 | OTC monograph not final | 2014-02-19 |
| nacellate solution 0.9% - 1000ml | New Drug Application | 2022-02-23 |
| nacellate solution 0.9% - 100ml | New Drug Application | 2022-02-23 |
| nacellate solution 0.9% - 250ml | New Drug Application | 2022-02-23 |
| nacellate solution 0.9% - 500ml | New Drug Application | 2022-02-23 |
| nasocalm | C200263 | 2025-03-28 |
Show 4 more
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Agency Specific
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Patent Expiration
ATC Codes
R: Respiratory system drugs
— R05: Cough and cold preparations
— R05C: Expectorants, excl. combinations with cough suppressants
— R05CB: Mucolytics
— R05CB01: Acetylcysteine
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01X: Other ophthalmologicals in atc
— S01XA: Other ophthalmologicals in atc
— S01XA08: Acetylcysteine
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AB: Antidotes
— V03AB23: Acetylcysteine
HCPCS
Code | Description |
|---|---|
| J0132 | Injection, acetylcysteine, 100 mg |
| J7604 | Acetylcysteine, inhalation solution, compounded product, administered through dme, unit dose form, per gram |
| J7608 | Acetylcysteine, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per gram |
Clinical
Clinical Trials
865 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney diseases | D007674 | EFO_0003086 | N08 | 4 | 12 | 13 | 9 | 13 | 45 |
| Syndrome | D013577 | — | — | 4 | 12 | 2 | 5 | 7 | 27 |
| Renal insufficiency | D051437 | — | N19 | 2 | 7 | 5 | 4 | 5 | 21 |
| Oxidative stress | D018384 | EFO_1001905 | — | 4 | 5 | 3 | 2 | 7 | 20 |
| Acute kidney injury | D058186 | — | N17 | — | 2 | 5 | 4 | 9 | 20 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | 1 | 1 | 17 | 19 |
| Chronic renal insufficiency | D051436 | — | N18 | 1 | 3 | 7 | 1 | 5 | 16 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | 2 | 8 | 6 | 16 |
| Cognitive dysfunction | D060825 | — | G31.84 | 5 | 7 | — | 1 | 4 | 14 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | 3 | 3 | 3 | 6 | 14 |
Show 130 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 7 | 9 | 2 | — | 53 | 70 |
| Covid-19 | D000086382 | — | U07.1 | 10 | 10 | 4 | — | 4 | 25 |
| Healthy volunteers/patients | — | — | — | 8 | — | 1 | — | 5 | 14 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 4 | 4 | 3 | — | 4 | 12 |
| Fibrosis | D005355 | — | — | 3 | 6 | 3 | — | 2 | 11 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | 4 | 1 | — | 6 | 11 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 3 | 4 | 1 | — | 3 | 10 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 2 | 3 | 1 | — | 6 | 10 |
| Pulmonary fibrosis | D011658 | — | J84.10 | 3 | 5 | 3 | — | 1 | 9 |
| Allergic rhinitis | D065631 | — | J30.9 | 2 | 2 | 1 | — | 6 | 9 |
Show 90 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Triple negative breast neoplasms | D064726 | — | — | 1 | 5 | — | — | 5 | 11 |
| Neoplasms | D009369 | — | C80 | 5 | 7 | — | — | 1 | 11 |
| Carcinoma | D002277 | — | C80.0 | 1 | 4 | — | — | 4 | 9 |
| Brain injuries | D001930 | — | S06.9 | 2 | 4 | — | — | 4 | 8 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 3 | 3 | — | — | 3 | 8 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 1 | — | — | 6 | 8 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | — | 3 | — | — | 4 | 7 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | 4 | — | — | 2 | 7 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 3 | 3 | — | — | 3 | 7 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 2 | 3 | — | — | 2 | 6 |
Show 201 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Radius fractures | D011885 | EFO_0003957 | S52.37 | 1 | — | — | — | 6 | 7 |
| Wrist fractures | D000092503 | — | S52.54 | 1 | — | — | — | 6 | 7 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 2 | — | — | — | 3 | 5 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | — | — | — | 1 | 2 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | 1 | — | — | — | 1 | 2 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | — | — | 1 | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | 1 | 2 |
| Glaucoma | D005901 | EFO_0000516 | H40 | 1 | — | — | — | 1 | 2 |
| Open-angle glaucoma | D005902 | EFO_0004190 | H40.1 | 1 | — | — | — | 1 | 2 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | 1 | — | — | — | 1 | 2 |
Show 45 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | — | — | — | 4 | 4 |
| Apnea | D001049 | — | R06.81 | — | — | — | — | 4 | 4 |
| Eye diseases | D005128 | EFO_0003966 | H44 | — | — | — | — | 4 | 4 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | — | — | — | 3 | 3 |
| Humeral fractures | D006810 | EFO_0003943 | S42.3 | — | — | — | — | 3 | 3 |
| Vascular dementia | D015140 | — | F01 | — | — | — | — | 2 | 2 |
| Hyperhomocysteinemia | D020138 | — | — | — | — | — | — | 2 | 2 |
| Memory disorders | D008569 | — | — | — | — | — | — | 2 | 2 |
| Amnesia | D000647 | EFO_1001454 | F44.0 | — | — | — | — | 2 | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 2 | 2 |
Show 131 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Acetylcysteine |
| INN | acetylcysteine |
| Description | N-acetyl-L-cysteine is an N-acetyl-L-amino acid that is the N-acetylated derivative of the natural amino acid L-cysteine. It has a role as an antiinfective agent, an antioxidant, an antiviral drug, an antidote to paracetamol poisoning, a vulnerary, a mucolytic, a human metabolite, a radical scavenger, a ferroptosis inhibitor and a geroprotector. It is a L-cysteine derivative, an acetylcysteine and a N-acetyl-L-amino acid. It is a conjugate acid of a N-acetyl-L-cysteinate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)N[C@@H](CS)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 616-91-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL600 |
| ChEBI ID | 28939 |
| PubChem CID | 12035 |
| DrugBank | DB06151 |
| UNII ID | WYQ7N0BPYC (ChemIDplus, GSRS) |
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Acetadote – Cumberland Pharmaceuticals
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Acetylcysteine
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Safety
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199,800 adverse events reported
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