Active substance
Cloxacillin
- SFDA 5
- US FDA 8
- Health Canada 9
- WHO EML 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| MONOCLOX 250MG VIAL | 250 mg | Powder for solution for injection/infusion · Intramuscular and intravenous use | 10 Vial | SAR 51.75 | NCE · Prescription | Medochemie Ltd | Valid |
| MONOCLOX 500 mg VIAL | 500 mg | Powder for solution for injection/infusion · Intramuscular and intravenous use | 10 Vial | SAR 66.35 | Generic · Prescription | Medochemie Ltd | Valid |
| CLOXA 1000MG VIAL | 1 g | Injection · Parenteral use | 1 Vial | SAR 2.50 | Generic · Prescription | SHIFA PHARMACEUTICAL INDUSTRIES | Invalid · Not Marketed |
| CLOXA 500MG VIAL | 500 mg | Injection · Parenteral use | 1 Vial | SAR 1.80 | Generic · Prescription | SHIFA PHARMACEUTICAL INDUSTRIES | Invalid · Not Marketed |
| ORBENIN 500MG VIAL | 500 mg | Solution · Parenteral use | 10 Vial | SAR 138.25 | NCE · Prescription | SMIITHKLINE BEECHAM | Invalid · Not Marketed |
Indications — CHI Daman Drug Formulary
BACTERIAL SKIN INFECTIONS - ERYSIPELAS AND CELLULITIS; BACTERIAL SKIN INFECTIONS - GAS GANGRENE; BACTERIAL SKIN INFECTIONS - PURULENT SKIN AND SOFT TISSUE INFECTIONS (CUTANEOUS ABSCESSES, FURUNCLES, CARBUNCLES); ENDOCARDITIS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; OSTEOMYELITIS; Pyogenic Arthritis
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CLOXACILLIN SODIUM | EQ 250MG BASE; EQ 500MG BASE | capsule · oral | APOTHECON | Discontinued | 1 Apr 1971 |
| CLOXAPEN | EQ 250MG BASE; EQ 500MG BASE | capsule · oral | GLAXOSMITHKLINE | Discontinued | 17 Sep 1974 |
| CLOXACILLIN SODIUM | EQ 250MG BASE; EQ 500MG BASE | capsule · oral | TEVA | Discontinued | 5 Jun 1980 |
| CLOXACILLIN SODIUM | EQ 125MG BASE/5ML | for solution · oral | TEVA | Discontinued | 15 Sep 1980 |
| TEGOPEN | EQ 125MG BASE/5ML | for solution · oral | APOTHECON | Discontinued | |
| CLOXAPEN | EQ 250MG BASE; EQ 500MG BASE | capsule · oral | GLAXOSMITHKLINE | Discontinued | |
| CLOXACILLIN SODIUM | EQ 125MG BASE/5ML | for solution · oral | TEVA | Discontinued | |
| TEGOPEN | EQ 125MG BASE/5ML | for solution · oral | APOTHECON | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| CLOXACILLIN FOR INJECTION | 02367408 | 500 MG / VIAL | POWDER FOR SOLUTION · INTRAMUSCULAR; INTRAVENOUS | STERIMAX INC |
| CLOXACILLIN FOR INJECTION | 02367416 | 1 G / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | STERIMAX INC |
| CLOXACILLIN FOR INJECTION | 02367424 | 2 G / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | STERIMAX INC |
| CLOXACILLIN FOR INJECTION | 02400081 | 10 G / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | STERIMAX INC |
| JAMP CLOXACILLIN | 02510731 | 250 MG | CAPSULE · ORAL | JAMP PHARMA CORPORATION |
| JAMP CLOXACILLIN | 02510758 | 500 MG | CAPSULE · ORAL | JAMP PHARMA CORPORATION |
| TEVA-CLOXACILLIN | 00337757 | 125 MG / 5 ML | GRANULES FOR SOLUTION · ORAL | TEVA CANADA LIMITED |
| TEVA-CLOXACILLIN | 00337765 | 250 MG | CAPSULE · ORAL | TEVA CANADA LIMITED |
| TEVA-CLOXACILLIN | 00337773 | 500 MG | CAPSULE · ORAL | TEVA CANADA LIMITED |
WHO WHO Model List of Essential Medicines (2025)
- 6.2.1. Access group antibiotics · core
First choice: Bacterial infection of joint; First choice: Osteomyelitis or osteitis; First choice: Bacterial cellulitis, erysipelas or lymphangitis; Second choice: Sepsis without septic shock
Oral > Liquid: 125 mg per 5 mL (as sodium salt) powder for oral liquid; 250 mg per 5 mL (as sodium salt) powder for oral liquid (EMLc) | Parenteral > General injections > unspecified: 500 mg in vial (as sodium salt) powder for injection; 250 mg in vial (as sodium salt) powder for injection (EMLc) | Oral > Solid > capsule: 500 mg (as sodium salt); 1 g (as sodium salt); 250 mg (as sodium salt) (EMLc) | Oral > Liquid: 125 mg per 5 mL (as sodium salt) powder for oral liquid (EMLc); 250 mg per 5 mL (as sodium salt) powder for oral liquid (EMLc) | Parenteral > General injections > unspecified: 500 mg in vial (as sodium salt) powder for injection (EMLc); 250 mg in vial (as sodium salt) powder for injection (EMLc) | Oral > Solid > capsule: 500 mg (as sodium salt) (EMLc); 1 g (as sodium salt) (EMLc); 250 mg (as sodium salt) (EMLc)
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.