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Drug ReportsAzithromycin
Azithromycin
Azasite, Azithromycin, Trovan/zithromax Compliance, Zithromax (azithromycin) is a small molecule pharmaceutical. Azithromycin was first approved as Zithromax on 1991-11-01. It is used to treat bacterial infections, chlamydia infections, haemophilus infections, infectious skin diseases, and mycoplasma pneumonia amongst others in the USA. It is known to target motilin receptor.
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COVID-19
Case Study: COVID-19
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
stomatognathic diseasesD009057
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Azasite, Azithromycin, Zithromax (discontinued: Azithromycin, Zithromax, Zmax)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Azithromycin
Tradename
Company
Number
Date
Products
ZITHROMAXPfizerN-050710 RX1995-10-19
2 products, RLD, RS
ZITHROMAXPfizerN-050711 RX1996-07-18
1 products, RLD
ZITHROMAXPfizerN-050733 RX1997-01-30
1 products, RLD, RS
ZITHROMAXPfizerN-050784 RX2002-05-24
1 products, RLD
AZASITEThea PharmaN-050810 RX2007-04-27
1 products, RLD, RS
Show 5 discontinued
Azithromycin dihydrate
+
Trovafloxacin mesylate
Tradename
Company
Number
Date
Products
TROVAN/ZITHROMAX COMPLIANCE PAKPfizerN-050762 DISCN1998-12-18
1 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
azasiteNew Drug Application2024-07-25
azithromycinANDA2025-06-13
azithromycin azithromycin dihydrateANDA2024-11-15
azithromycin dihydrateANDA2025-06-12
azithromycin monohydrateANDA2023-06-20
zithromaxNew Drug Application2025-05-28
zmaxNew Drug Application2011-01-26
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
J01: Antibacterials for systemic use
J01F: Macrolides, lincosamides and streptogramins
J01FA: Macrolides
J01FA10: Azithromycin
J01R: Combinations of antibacterials
J01RA: Combinations of antibacterials
J01RA07: Azithromycin, fluconazole and secnidazole
S: Sensory organ drugs
S01: Ophthalmologicals
S01A: Antiinfective ophthalmologics
S01AA: Antibiotics, ophthalmologic
S01AA26: Azithromycin
HCPCS
Code
Description
J0456
Injection, azithromycin, 500 mg
Q0144
Azithromycin dihydrate, oral, capsules/powder, 1 gram
Clinical
Clinical Trials
682 clinical trials
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Indications Phases 4
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Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_000054433
MalnutritionD044342EFO_0008572E40-E4622
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAzithromycin
INNazithromycin
Description
Azithromycin is a macrolide antibiotic useful for the treatment of bacterial infections. It has a role as an antibacterial drug, an environmental contaminant and a xenobiotic.
Classification
Small molecule
Drug classantibiotics (Streptomyces strains)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@H](N(C)C)[C@H]2O)[C@](C)(O)C[C@@H](C)CN(C)[C@H](C)[C@@H](O)[C@]1(C)O
Identifiers
PDB
CAS-ID83905-01-5
RxCUI1299904
ChEMBL IDCHEMBL529
ChEBI ID2955
PubChem CID447043
DrugBankDB00207
UNII IDF94OW58Y8V (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Zithromax Pfizer
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Estimated US medical usage
Azithromycin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 61,312 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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40,245 adverse events reported
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