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Acetylcysteine
Acetadote (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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
respiratory tract diseasesD012140
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
signs and symptoms pathological conditionsD013568
chemically-induced disordersD064419
Trade Name
FDA
EMA
Acetadote (generic drugs available since 1994-08-30, discontinued: 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
ACETADOTECumberland PharmaceuticalsN-021539 RX2004-01-23
1 products, RLD, RS
Show 2 discontinued
Acetylcysteine
+
Isoproterenol hydrochloride
Tradename
Company
Number
Date
Products
MUCOMYST W/ ISOPROTERENOLMead Johnson NutritionN-017366 DISCN1982-01-01
1 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
acetadoteNew Drug Application2020-01-23
acetylcysteineANDA2023-05-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
amyloidosisEFO_1001875D000686E85
bronchiectasisHP_0002110D001987J47
bronchitis—D001991J40
cystic fibrosisEFO_0000390D003550E84
pneumoniaEFO_0003106D011014J18
poisoningEFO_0008546D011041T65.91
pulmonary emphysema—D011656J43
respiratory distress syndromeEFO_1000637D012128J80
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Acetylcysteine, Cetylev, Arbor Pharms Llc
87478942032-05-08DPU-1373
94274212032-05-08DP
95612042032-05-08U-1373
Acetylcysteine, Acetadote, Cumberland Pharms
87227382032-04-06U-1373
93270282031-07-21U-1839
81483562026-05-21DP
83994452025-08-24U-1373
86530612025-08-24U-1373
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
1 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Inborn urea cycle disordersD056806E72.211———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameACETYLCYSTEINE
INNacetylcysteine
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-ID616-91-1
RxCUI197
ChEMBL IDCHEMBL600
ChEBI ID28939
PubChem CID12035
DrugBankDB06151
UNII IDWYQ7N0BPYC (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Acetadote - Cumberland Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 39,924 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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40 adverse events reported
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