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Drug ReportsCephalexin
Cephalexin
Cephalexin, Keftab (cephalexin) is a small molecule pharmaceutical. Cephalexin was first approved as Keflet on 1982-01-01. It is used to treat bacterial infections, bacterial pneumonia, bacterial skin diseases, escherichia coli infections, and haemophilus infections amongst others in the USA.
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
musculoskeletal diseasesD009140
stomatognathic diseasesD009057
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
wounds and injuriesD014947
Trade Name
FDA
EMA
Cephalexin (discontinued: Cephalexin, Keflet, Keflex, Keftab, Panixine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cephalexin
Tradename
Company
Number
Date
Products
KEFLETEli LillyN-050440 DISCN1982-01-01
3 products
KEFLEXPragma PharmaceuticalsN-050405 DISCN1982-01-01
4 products, RLD
KEFLEXPragma PharmaceuticalsN-050406 DISCN1982-01-01
3 products, RLD
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Cephalexin hydrochloride
Tradename
Company
Number
Date
Products
KEFTABEli LillyN-050614 DISCN1987-10-29
3 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
cephalexinANDA2025-09-30
keflexANDA2021-06-18
orapazunapproved drug other2025-02-11
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
urinary tract infectionsEFO_0003103D014552N39.0
otitis mediaEFO_0004992D010033H66.9
bacterial infections—D001424A49
bacterial skin diseases—D017192—
escherichia coli infectionsEFO_1001318D004927B96.20
soft tissue infections—D018461—
streptococcal infectionsEFO_1001476D013290—
surgical wound infection—D013530—
pharyngitis—D010612R07.0
bacterial pneumoniaEFO_1001272D018410J15.9
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Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01D: Other beta-lactam antibacterials in atc
— J01DB: First-generation cephalosporins
— J01DB01: Cefalexin
HCPCS
No data
Clinical
Clinical Trials
112 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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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———2————2
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCephalexin
INNcefalexin
Description
Cefalexin, also spelled cephalexin, is an antibiotic that can treat a number of bacterial infections. It kills gram-positive and some gram-negative bacteria by disrupting the growth of the bacterial cell wall. Cefalexin is a β-lactam antibiotic within the class of first-generation cephalosporins. It works similarly to other agents within this class, including intravenous cefazolin, but can be taken by mouth.
Classification
Small molecule
Drug classFirst-generation cephalosporin
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Structure (InChI/SMILES or Protein Sequence)
CC1=C(C(=O)O)N2C(=O)[C@@H](NC(=O)[C@H](N)c3ccccc3)[C@H]2SC1.O
Identifiers
PDB—
CAS-ID23325-78-2
RxCUI—
ChEMBL IDCHEMBL1200544
ChEBI ID3535
PubChem CID2666
DrugBankDB00567
UNII ID5SFF1W6677 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
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Estimated US medical usage
Cephalexin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 14,467 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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10,092 adverse events reported
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