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
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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
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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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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acetadote | New Drug Application | 2024-11-30 |
| acetylcysteine | ANDA | 2025-01-15 |
| 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 |
| natural care concha de nacar and rosa mosqueta crema facial fps 15 para una apariencia mas clara fm | OTC monograph final | 2015-10-20 |
| premasol - sulfite-free (amino acid) | ANDA | 2022-08-04 |
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Indications
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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 |
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690 clinical trials
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
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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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12,484 adverse events reported
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