Active substance
Cefalexin
- SFDA 56
- US FDA 58
- Health Canada 24
- US price lines 9
- NHS prices 8
- WHO EML 1
- Safety 4
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| CEPHADAR | 25 mg/ml | Granules for oral suspension · Oral use | 1 Bottle | SAR 6.70 | Generic · Prescription | DAR ALDAWA | Valid |
| CEPHADAR | 250 mg | Capsule, hard · Oral use | 500 Blister | SAR 214.70 | Generic · Prescription | DAR ALDAWA | Valid |
| CEPHADAR CAPSULES 250MG | 250 mg | Capsule · Oral use | 20 Blister | SAR 10.15 | Generic · Prescription | DAR ALDAWA | Valid |
| CEPHADAR FORTE | 500 mg | Capsule, hard · Oral use | 20 Blister | SAR 18.10 | Generic · Prescription | DAR ALDAWA | Valid |
| CEPHALEX 500MG CAPS | 500 mg | Capsule · Oral use | 20 Blister | SAR 32.45 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| CEPHALEX ORAL SUSP 250MG-5ML | 50 mg/ml | Suspension · Oral use | 1 Bottle | SAR 17.95 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| KEFLEX 250MG-5ML SUSPENTION | 50 mg/ml | Powder for oral suspension · Oral use | 1 Bottle | SAR 23.75 | Generic · Prescription | COOPER PHARMA | Valid |
| KEFLEX 500MG TAB | 500 mg | Tablet · Oral use | 20 Blister | SAR 48.10 | Generic · Prescription | COOPER PHARMA | Valid |
| LEXEK 125MG-5ML SUSP | 25 mg/ml | Powder for oral suspension · Oral use | 1 Bottle | SAR 10.85 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Valid |
| LEXEK 250MG CAPS | 250 mg | Capsule, hard · Oral use | 20 Blister | SAR 14.30 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Valid |
| LEXEK 250MG-5ML SUSP | 250 mg/ml | Powder for oral suspension · Oral use | 1 Bottle | SAR 18.85 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Valid |
| Lexek 500MG CAPS | 500 mg | Capsule, hard · Oral use | 20 Blister | SAR 22.50 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Valid |
| MIDAFLEX 125MG-5MLSUSP | 25 mg/ml | Oral suspension · Oral use | 1 Bottle | SAR 5.90 | Generic · Prescription | Middle East Pharmaceutical and Chemical Industries and Medical Appliances Co. | Valid |
| MIDAFLEX 250 mg capsule | 250 mg | Capsule · Oral use | 20 Blister | SAR 9.10 | Generic · Prescription | Middle East Pharmaceutical and Chemical Industries and Medical Appliances Co. | Valid |
| MIDAFLEX 250 mg oral suspension | 50 mg/ml | Oral suspension · Oral use | 1 Bottle | SAR 9.10 | Generic · Prescription | Middle East Pharmaceutical and Chemical Industries and Medical Appliances Co. | Valid |
| MIDAFLEX 500MG CAPSULE | 500 mg | Capsule · Oral use | 20 Blister | SAR 15.10 | Generic · Prescription | Middle East Pharmaceutical and Chemical Industries and Medical Appliances Co. | Valid |
| MONOCEF 125MG-5ML SUSPENSION | 25 mg/ml | Powder for suspension · Oral use | 1 Bottle | SAR 10.20 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| MONOCEF 250MG CAPSULE | 250 mg | Capsule · Oral use | 20 Blister | SAR 19.20 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| MONOCEF 250MG-5ML SUSPENSION | 50 mg/ml | Powder for suspension · Oral use | 1 Bottle | SAR 16.15 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| MONOCEF 500MG CAPSULE | 500 mg | Capsule · Oral use | 20 Blister | SAR 29.15 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| CEFADIN 250MG CAP. | 250 mg | Capsule · Oral use | 12 Blister | SAR 16.00 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Withdrawn by MAH · Not Marketed |
| CEFADIN 500MG CAP. | 500 mg | Capsule · Oral use | 12 Blister | SAR 31.40 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Withdrawn by MAH · Not Marketed |
| CEFAXINE 250MG CAPSULES | 250 mg | Capsule · Oral use | 20 Blister | SAR 10.00 | Generic · Prescription | MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES | Withdrawn by MAH · Not Marketed |
| CEFAXINE 500MG CAPSULES | 500 mg | Capsule · Oral use | 20 Blister | SAR 16.40 | Generic · Prescription | MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES | Withdrawn by MAH · Not Marketed |
| CEPHADAR FORTE | 500 mg | Capsule · Oral use | 1 Blister | SAR 10.50 | Generic · Prescription | DAR ALDAWA | Withdrawn by MAH · Not Marketed |
31 more — full table
Indications — CHI Daman Drug Formulary
ACUTE PYELONEPHRITIS; BACTERIAL SKIN INFECTIONS - ERYSIPELAS AND CELLULITIS; BACTERIAL SKIN INFECTIONS - IMPETIGO AND ECTHYMA; BACTERIAL SKIN INFECTIONS - PURULENT SKIN AND SOFT TISSUE INFECTIONS (CUTANEOUS ABSCESSES, FURUNCLES, CARBUNCLES); BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; DENTAL ABSCESS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; INTRA-ABDOMINAL INFECTIONS; LOWER URINARY TRACT INFECTIONS; OSTEOMYELITIS; PHARYNGITIS; RECURRENT URINARY TRACT INFECTIONS (UTI)
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CEPHALEXIN | EQ 250MG BASE; EQ 500MG BASE | capsule · oral | TEVA | Prescription | 13 Feb 1987 |
| CEPHALEXIN | EQ 125MG BASE/5ML; EQ 250MG BASE/5ML | for suspension · oral | TEVA | Prescription | 13 Feb 1987 |
| CEPHALEXIN | EQ 250MG BASE; EQ 500MG BASE | capsule · oral | AJENAT PHARMS | Prescription | 15 Jul 1988 |
| CEPHALEXIN | EQ 500MG BASE; EQ 250MG BASE | tablet · oral | TEVA | Prescription | 12 Jan 1989 |
| CEPHALEXIN | EQ 250MG BASE; EQ 500MG BASE | capsule · oral | CHARTWELL RX | Prescription | 24 Feb 2005 |
| CEPHALEXIN | EQ 250MG BASE; EQ 500MG BASE | capsule · oral | ANDA REPOSITORY | Prescription | 28 Jun 2005 |
| CEPHALEXIN | EQ 125MG BASE/5ML; EQ 250MG BASE/5ML | for suspension · oral | LUPIN | Prescription | 17 Aug 2005 |
| CEPHALEXIN | EQ 250MG BASE; EQ 500MG BASE; EQ 750MG BASE | capsule · oral | AUROBINDO PHARMA | Prescription | 16 Nov 2005 |
| CEPHALEXIN | EQ 250MG BASE; EQ 500MG BASE | capsule · oral | LUPIN | Prescription | 25 Nov 2005 |
| CEPHALEXIN | EQ 125MG BASE/5ML; EQ 250MG BASE/5ML | for suspension · oral | YUNG SHIN PHARM | Prescription | 25 Jul 2007 |
| CEPHALEXIN | EQ 250MG BASE; EQ 500MG BASE; EQ 333MG BASE; EQ 750MG BASE | capsule · oral | ALKEM LABS LTD | Prescription | 20 Dec 2010 |
| CEPHALEXIN | EQ 125MG BASE/5ML; EQ 250MG BASE/5ML | for suspension · oral | ALKEM LABS LTD | Prescription | 26 Mar 2019 |
| CEPHALEXIN | EQ 250MG BASE; EQ 500MG BASE | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 27 Sep 2024 |
| CEPHALEXIN | EQ 250MG BASE; EQ 500MG BASE | tablet · oral | ALKEM LABS LTD | Prescription | 27 Sep 2024 |
| CEPHALEXIN | EQ 125MG BASE/5ML; EQ 250MG BASE/5ML | for suspension · oral | AUROBINDO PHARMA | Prescription | 9 Jun 2026 |
| KEFLEX | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | capsule · oral | PRAGMA | Discontinued | 4 Jan 1971 |
| KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*; EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | for suspension · oral | PRAGMA | Discontinued | 4 Jan 1971 |
| KEFLET | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 1GM BASE; EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | LILLY | Discontinued | 12 Oct 1972 |
| CEPHALEXIN | EQ 250MG BASE; EQ 500MG BASE | capsule · oral | IVAX SUB TEVA PHARMS | Discontinued | 26 Apr 1976 |
| CEPHALEXIN | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*; EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*; EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | for suspension · oral | FACTA FARMA | Discontinued | 27 Mar 1978 |
| CEPHALEXIN | EQ 250MG BASE; EQ 500MG BASE | capsule · oral | FACTA FARMA | Discontinued | 27 Mar 1978 |
| KEFLET | EQ 250MG BASE; EQ 500MG BASE | tablet · oral | LILLY | Discontinued | 1 Dec 1986 |
| CEPHALEXIN | EQ 500MG BASE | capsule · oral | BARR | Discontinued | 22 Apr 1987 |
| CEPHALEXIN | EQ 250MG BASE | capsule · oral | TEVA | Discontinued | 24 Apr 1987 |
| CEPHALEXIN | EQ 500MG BASE | capsule · oral | TEVA | Discontinued | 24 Apr 1987 |
33 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-CEPHALEX | 00768715 | 500 MG | TABLET · ORAL | APOTEX INC |
| APO-CEPHALEX | 00768723 | 250 MG | TABLET · ORAL | APOTEX INC |
| AURO-CEPHALEXIN | 02470578 | 250 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-CEPHALEXIN | 02470586 | 500 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-CEPHALEXIN | 02497743 | 125 MG / 5 ML | POWDER FOR SUSPENSION · ORAL | AURO PHARMA INC |
| AURO-CEPHALEXIN | 02497751 | 250 MG / 5 ML | POWDER FOR SUSPENSION · ORAL | AURO PHARMA INC |
| CEPHALEXIN | 02495651 | 500 MG | TABLET · ORAL | SIVEM PHARMACEUTICALS ULC |
| CEPHALEXIN | 02521253 | 250 MG | TABLET · ORAL | SANIS HEALTH INC |
| CEPHALEXIN | 02521261 | 500 MG | TABLET · ORAL | SANIS HEALTH INC |
| JAMP CEPHALEXIN | 02494698 | 250 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP CEPHALEXIN | 02494701 | 500 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP CEPHALEXIN SUSPENSION | 02528436 | 125 MG / 5 ML | POWDER FOR SUSPENSION · ORAL | JAMP PHARMA CORPORATION |
| JAMP CEPHALEXIN SUSPENSION | 02528444 | 250 MG / 5 ML | POWDER FOR SUSPENSION · ORAL | JAMP PHARMA CORPORATION |
| LUPIN-CEPHALEXIN | 02469170 | 125 MG / 5 ML | POWDER FOR SUSPENSION · ORAL | LUPIN PHARMA CANADA LIMITED |
| LUPIN-CEPHALEXIN | 02469189 | 250 MG / 5 ML | POWDER FOR SUSPENSION · ORAL | LUPIN PHARMA CANADA LIMITED |
| LUPIN-CEPHALEXIN | 02471140 | 250 MG | TABLET · ORAL | LUPIN PHARMA CANADA LIMITED |
| LUPIN-CEPHALEXIN | 02471159 | 500 MG | TABLET · ORAL | LUPIN PHARMA CANADA LIMITED |
| PRO-CEPHALEXIN | 02562596 | 250 MG / 5 ML | POWDER FOR SUSPENSION · ORAL | PRO DOC LIMITEE |
| TEVA-CEPHALEXIN | 00342084 | 250 MG | CAPSULE · ORAL | TEVA CANADA LIMITED |
| TEVA-CEPHALEXIN | 00342114 | 500 MG | CAPSULE · ORAL | TEVA CANADA LIMITED |
| TEVA-CEPHALEXIN | 00583413 | 250 MG | TABLET · ORAL | TEVA CANADA LIMITED |
| TEVA-CEPHALEXIN | 00583421 | 500 MG | TABLET · ORAL | TEVA CANADA LIMITED |
| TEVA-CEPHALEXIN 125 | 00342106 | 125 MG / 5 ML | POWDER FOR SUSPENSION · ORAL | TEVA CANADA LIMITED |
| TEVA-CEPHALEXIN 250 | 00342092 | 250 MG / 5 ML | POWDER FOR SUSPENSION · ORAL | TEVA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | CEPHALEXIN 125 MG/5 ML SUSP | $0.07487 | per ML | 23 Sep 2026 |
| US NADAC | CEPHALEXIN 125 MG/5 ML SUSP | $0.04454 | per ML | 23 Sep 2026 |
| US NADAC | CEPHALEXIN 250 MG CAPSULE | $0.09048 | per EA | 23 Sep 2026 |
| US NADAC | CEPHALEXIN 250 MG TABLET | $0.74316 | per EA | 23 Sep 2026 |
| US NADAC | CEPHALEXIN 250 MG/5 ML SUSP | $0.07097 | per ML | 23 Sep 2026 |
| US NADAC | CEPHALEXIN 250 MG/5 ML SUSP | $0.04955 | per ML | 23 Sep 2026 |
| US NADAC | CEPHALEXIN 500 MG CAPSULE | $0.12004 | per EA | 23 Sep 2026 |
| US NADAC | CEPHALEXIN 500 MG TABLET | $1.26538 | per EA | 23 Sep 2026 |
| US NADAC | CEPHALEXIN 750 MG CAPSULE | $5.11155 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Cefalexin 125mg/5ml oral suspension | £8.72 | 100 ml | 1 Oct 2026 |
| NHS Drug Tariff | Cefalexin 125mg/5ml oral suspension sugar free | £2.92 | 100 ml | 1 Oct 2026 |
| NHS Drug Tariff | Cefalexin 250mg capsules | £1.70 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Cefalexin 250mg tablets | £4.06 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Cefalexin 250mg/5ml oral suspension | £9.76 | 100 ml | 1 Oct 2026 |
| NHS Drug Tariff | Cefalexin 250mg/5ml oral suspension sugar free | £3.38 | 100 ml | 1 Oct 2026 |
| NHS Drug Tariff | Cefalexin 500mg capsules | £2.05 | 21 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Cefalexin 500mg tablets | £3.09 | 21 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 6.2.1. Access group antibiotics · core
First choice: Bacterial cellulitis, erysipelas or lymphangitis; Second choice: Chronic obstructive pulmonary disease with acute exacerbation; Second choice: Acute pharyngitis
Oral > Liquid: 125 mg per 5 mL (anhydrous) powder for oral liquid; 250 mg per 5 mL (anhydrous) powder for oral liquid | Oral > Solid: 250 mg (as monohydrate); 500 mg (as monohydrate) (EML) | Oral > Solid > dispersible tablet: 125 mg (EMLc); 250 mg (EMLc) | Oral > Solid: 250 mg (as monohydrate); 500 mg (as monohydrate)
Safety signals and safety-related labeling changes
- US FDA 3 Aug 2026 KEFLEX — safety-related labeling change
Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations - US FDA 5 Mar 2026 KEFLEX — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 8 Mar 2018 PRAC signal: Acute generalised exanthematous pustulosis (AGEP)
Action for MAH: update of the product information: Yes - EMA PRAC 1 Sep 2017 PRAC signal: Acute generalised exanthematous pustulosis (AGEP)
Action for MAH: update of the product information: No
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.