Cefotaxime
Claforan (cefotaxime) is a small molecule pharmaceutical. Cefotaxime was first approved as Claforan on 1982-01-01. It is used to treat acinetobacter infections, bacterial infections, bacterial meningitis, bacterial pneumonia, and bacterial skin diseases amongst others in the USA.
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Drug Products
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New Drug Application (NDA)
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Abbreviated New Drug Application (ANDA)
Cefotaxime sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER | B. Braun Medical | N-050792 DISCN | 2004-07-29 | 1 products |
| CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER | B. Braun Medical | N-050792 DISCN | 2004-07-29 | 1 products |
| CLAFORAN | Validus Pharmaceuticals | N-050547 DISCN | 1982-01-01 | 4 products, RLD |
| CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Validus Pharmaceuticals | N-050596 DISCN | 1985-05-20 | 1 products |
| CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER | Validus Pharmaceuticals | N-050596 DISCN | 1985-05-20 | 1 products |
| CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | Validus Pharmaceuticals | N-050596 DISCN | 1985-05-20 | 1 products |
| CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER | Validus Pharmaceuticals | N-050596 DISCN | 1985-05-20 | 1 products |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cefotaxime | unapproved drug for use in drug shortage | 2026-06-15 |
| claforan | New Drug Application | 2026-08-14 |
Indications
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Agency Specific
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Patent Expiration
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HCPCS
Code | Description |
|---|---|
| J0698 | Injection, cefotaxime sodium, per gm |
Clinical
Clinical Trials
244 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 4 | 11 | 9 | 9 | 14 | 46 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | 6 | 13 | 11 | 7 | 35 |
| Communicable diseases | D003141 | — | — | 3 | 5 | 7 | 7 | 9 | 31 |
| Gonorrhea | D006069 | DOID_7551 | A54 | 4 | 3 | 8 | 3 | — | 18 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | 5 | 4 | 6 | 15 |
| Appendicitis | D001064 | EFO_0007149 | K37 | 1 | 3 | 1 | 3 | 6 | 14 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | 1 | 2 | 4 | 5 | 2 | 13 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | 2 | 1 | 7 | 10 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | 4 | 6 | 1 | — | 9 |
| Surgical wound infection | D013530 | — | — | 1 | 2 | 3 | 2 | 1 | 8 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial infections | D001424 | — | A49 | 1 | — | 1 | — | 5 | 7 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 1 | 2 | — | 1 | 4 |
| Lyme disease | D008193 | — | A69.2 | — | 1 | 2 | — | 1 | 4 |
| Antibiotic prophylaxis | D019072 | — | — | — | 1 | 2 | — | 1 | 4 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 2 | 2 | — | — | 3 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | 1 | — | 2 | — | — | 3 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | 2 | 2 | — | — | 3 |
| Healthy volunteers/patients | — | — | — | 2 | 2 | 1 | — | — | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 1 | — | 2 | 3 |
| Post-lyme disease syndrome | D000077342 | — | — | 1 | — | 2 | — | — | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endometritis | D004716 | EFO_1001312 | — | — | 2 | — | — | 1 | 3 |
| Coinfection | D060085 | — | — | — | 1 | — | — | 2 | 3 |
| Chlamydia infections | D002690 | EFO_0007205 | A74.9 | — | 1 | — | — | 1 | 2 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 1 | — | — | 1 | 2 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 1 | — | — | — | 1 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | 1 | — | — | — | 1 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | 1 | — | — | — | 1 |
| Ulcer | D014456 | MPATH_579 | — | — | 1 | — | — | — | 1 |
| Subacute bacterial endocarditis | D004698 | EFO_1001193 | — | — | 1 | — | — | — | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 4 | — | — | — | — | 4 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 2 | — | — | — | — | 2 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | — | — | — | — | 1 |
| Focus groups | D017144 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | — | — | — | — | 2 | 2 |
| Hiv seropositivity | D006679 | — | — | — | — | — | — | 2 | 2 |
| Varicose veins | D014648 | — | I83.90 | — | — | — | — | 2 | 2 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | — | — | — | 1 | 1 |
| Drug monitoring | D016903 | — | — | — | — | — | — | 1 | 1 |
| Jaundice | D007565 | — | R17 | — | — | — | — | 1 | 1 |
| Propionibacterium acnes | D011425 | NCBITaxon_1747 | — | — | — | — | — | 1 | 1 |
| Cellulitis | D002481 | EFO_0003035 | L03.90 | — | — | — | — | 1 | 1 |
| Aseptic meningitis | D008582 | EFO_1000823 | G03.0 | — | — | — | — | 1 | 1 |
| Shock | D012769 | — | R57.1 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cefotaxime |
| INN | cefotaxime |
| Description | (6R,7R)-3-(acetyloxymethyl)-7-[[2-(2-amino-4-thiazolyl)-2-methoxyimino-1-oxoethyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid is a cephalosporin. |
| Classification | Small molecule |
| Drug class | cephalosporins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CO/N=C(\C(=O)N[C@@H]1C(=O)N2C(C(=O)O)=C(COC(C)=O)CS[C@H]12)c1csc(N)n1 |
Identifiers
| PDB | — |
| CAS-ID | 63527-52-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1730 |
| ChEBI ID | 204928 |
| PubChem CID | 5479527 |
| DrugBank | DB00493 |
| UNII ID | N2GI8B1GK7 (ChemIDplus, GSRS) |
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3,994 adverse events reported
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