Regulatory PathRegulatory requirements compared

Active substance

Clarithromycin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
CLAMYCIN 500 MG TABLET500 mgFilm-coated tablet · Oral use14 BlisterSAR 63.15Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
CLAREX 500MG TABLET500 mgFilm-coated tablet · Oral use14 BlisterSAR 51.15Generic · PrescriptionSAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL COValid
CLARIDAR250 mgFilm-coated tablet · Oral use14 BlisterSAR 24.45Generic · PrescriptionDAR ALDAWAValid
CLARIDAR 500 mg film-coated tablet500 mgFilm-coated tablet · Oral use14 BlisterSAR 41.45Generic · PrescriptionDAR ALDAWAValid
CLARIDAR XL 500 mg Tablet500 mgExtended-release tablet · Oral use7 BlisterSAR 43.90Generic · PrescriptionDAR ALDAWAValid
CLARIDAR XL 500 mg Tablet500 mgProlonged-release tablet · Oral use14 BlisterSAR 57.15Generic · PrescriptionDAR Al DAWAValid
CLARIMAC 500 mg film-coated tablet500 mgFilm-coated tablet · Oral use14 BlisterSAR 54.10Generic · PrescriptionRIYADH PHARMAValid
CLARITT 125 MG - 5 ML SUSPENSION25 mg/mlSuspension · Oral use1 BottleSAR 26.90Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
CLARITT 250 MG - 5 ML SUSPENSION50 mg/mlSuspension · Oral use1 BottleSAR 51.20Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
CLARITT 250 MG FILM COATED250 mgExtended-release tablet · Oral use14 BlisterSAR 46.90Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
CLARITT 500 MG FILM COATED TAB500 mgFilm-coated tablet · Oral use14 BlisterSAR 70.00Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
CLARITT XL 500 MG EXTENDED RELEASE TAB.500 mgExtended-release tablet · Oral use7 BlisterSAR 48.80Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
CLARITT XL 500MG EXTENDED RELEASE TABLETS500 mgExtended-release tablet · Oral use14 BlisterSAR 72.00Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
CLARIXIN 500 MG TABLET500 mgFilm-coated tablet · Oral use14 BlisterSAR 51.15Generic · PrescriptionMed City PharmaValid
CLERON 250MG F.C.TABLET250 mgFilm-coated tablet · Oral use14 BlisterSAR 22.00Generic · PrescriptionNational Pharmaceutical Industries Co. (SAOG)Valid
CLERON 500MG F.C.TABLET500 mgFilm-coated tablet · Oral use14 BlisterSAR 32.50Generic · PrescriptionNational Pharmaceutical Industries Co. (SAOG)Valid
EMIMYCIN 500 MG TABLETS500 mgFilm-coated tablet · Oral use14 BlisterSAR 40.10Generic · PrescriptionGLOBAL PHARMAValid
ERACID 250MG TABLET250 mgFilm-coated tablet · Oral use14 BlisterSAR 19.35Generic · PrescriptionThe Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)Valid
ERACID 500MG FILM COATED TABLETS500 mgFilm-coated tablet · Oral use14 BlisterSAR 37.30Generic · PrescriptionThe Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)Valid
KLACID 125MG-5ML SUSP25 mg/mlGranules for suspension · Oral use1 BottleSAR 27.95NCE · PrescriptionAbbott Laboratories LimitedValid
KLACID 125MG-5ML SUSP25 mg/mlOral suspension · Oral use100 BottleSAR 46.60NCE · PrescriptionAbbott Laboratories LimitedValid
KLACID 250MG TAB250 mgTablet · Oral use14 BlisterSAR 60.40NCE · PrescriptionAbbott Laboratories GmbHValid
KLACID 500MG COATED TAB500 mgCoated tablet · Oral use14 BlisterSAR 90.20NCE · PrescriptionAbbott LaboratoriesValid
KLACID 500MG IV POWDER FOR INJECTION500 mgPowder for injection · Intravenous use1 VialSAR 54.90NCE · PrescriptionAbbott Laboratories LimitedValid
KLACID XL 500MG TAB500 mgExtended-release tablet · Oral use14 BlisterSAR 85.95Generic · PrescriptionAbbott LaboratoriesValid

19 more — full table

Indications — CHI Daman Drug Formulary

ACUTE COUGH; ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS); ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); BACTERIAL SKIN INFECTIONS - ERYSIPELAS AND CELLULITIS; BACTERIAL SKIN INFECTIONS - IMPETIGO AND ECTHYMA; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-EVIDENCE BASED FIRST LINE TREATMENT STRATEGY; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-SALVAGE THERAPIES; COMMUNITY ACQUIRED PNEUMONEA; DENTAL ABSCESS; ENDOCARDITIS; HOSPITAL AND VENTILATER ACQUIRED PNEUMONIA; HUMAN IMMUNODEFICIENCY VIRUS; MARGINAL ZONE LYMPHOMA; OTITIS MEDIA; PERICORONITIS; PHARYNGITIS; SINUSITIS; TRAVEL RELATED INFECTIONS-TREATMENT

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
CLARITHROMYCIN500MGtablet, extended release · oralACTAVIS LABS FL INCPrescription24 Jun 2004
CLARITHROMYCIN500MGtablet, extended release · oralDR REDDYS LABS SAPrescription18 May 2005
CLARITHROMYCIN500MGtablet · oralSANDOZPrescription25 Aug 2005
CLARITHROMYCIN250MGtablet · oralSANDOZPrescription18 Oct 2005
CLARITHROMYCIN250MG; 500MGtablet · oralCHARTWELLPrescription20 Aug 2007
CLARITHROMYCIN125MG/5ML; 250MG/5MLfor suspension · oralSANDOZPrescription4 Sep 2007
CLARITHROMYCIN250MG; 500MGtablet · oralAUROBINDOPrescription25 Jul 2012
CLARITHROMYCIN250MG; 500MGtablet · oralNOVITIUM PHARMAPrescription10 Jun 2013
CLARITHROMYCIN250MG; 500MGtablet · oralHEC PHARMPrescription28 Sep 2015
CLARITHROMYCIN500MGtablet, extended release · oralMPP PHARMAPrescription29 Feb 2016
CLARITHROMYCIN500MGtablet, extended release · oralSUNSHINEPrescription9 Jul 2018
CLARITHROMYCIN250MG; 500MGtablet · oralALEMBICPrescription31 Jan 2022
BIAXIN250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralABBVIEDiscontinued31 Oct 1991
BIAXIN XL250MG; 500MGtablet · oralABBVIE INCDiscontinued23 Dec 1993
BIAXIN125MG/5ML; 250MG/5ML; 187MG/5MLfor suspension · oralABBVIEDiscontinued23 Dec 1993
BIAXIN XL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet, extended release · oralABBVIEDiscontinued3 Mar 2000
CLARITHROMYCIN500MG; 250MGtablet · oralHIKMA PHARMSDiscontinued25 May 2004
CLARITHROMYCIN250MG; 500MGtablet · oralSUN PHARM INDS LTDDiscontinued24 Sep 2004
CLARITHROMYCIN1GMtablet, extended release · oralRANBAXYDiscontinued26 Jan 2005
CLARITHROMYCIN250MG; 500MGtablet · oralPHARMOBEDIENTDiscontinued11 Mar 2005
CLARITHROMYCIN250MG; 500MGtablet · oralIVAX SUB TEVA PHARMSDiscontinued31 May 2005
CLARITHROMYCIN250MG; 500MGtablet · oralTEVADiscontinued31 May 2005
CLARITHROMYCIN500MGtablet, extended release · oralANI PHARMSDiscontinued25 Aug 2005
CLARITHROMYCIN250MG; 500MGtablet · oralWOCKHARDTDiscontinued31 May 2006
CLARITHROMYCIN125MG/5ML; 250MG/5MLfor suspension · oralSUN PHARM INDS LTDDiscontinued30 Aug 2007

2 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-CLARITHROMYCIN02274744250 MGTABLET · ORALAPOTEX INC
APO-CLARITHROMYCIN02274752500 MGTABLET · ORALAPOTEX INC
APO-CLARITHROMYCIN XL02413345500 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
BIAXIN02146908125 MG / 5 MLGRANULES FOR SUSPENSION · ORALBGP PHARMA ULC
BIAXIN02244641250 MG / 5 MLGRANULES FOR SUSPENSION · ORALBGP PHARMA ULC
BIAXIN BID01984853250 MGTABLET · ORALBGP PHARMA ULC
BIAXIN BID02126710500 MGTABLET · ORALBGP PHARMA ULC
CLARITHROMYCIN02442469250 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
CLARITHROMYCIN02442485500 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
CLARITHROMYCIN02466120250 MGTABLET · ORALSANIS HEALTH INC
CLARITHROMYCIN02466139500 MGTABLET · ORALSANIS HEALTH INC
M-CLARITHROMYCIN02471396500 MGTABLET · ORALMANTRA PHARMA INC
PRO-CLARITHROMYCIN02324482250 MGTABLET · ORALPRO DOC LIMITEE
PRO-CLARITHROMYCIN02324490500 MGTABLET · ORALPRO DOC LIMITEE
SANDOZ CLARITHROMYCIN02266539250 MGTABLET · ORALSANDOZ CANADA INCORPORATED
SANDOZ CLARITHROMYCIN02266547500 MGTABLET · ORALSANDOZ CANADA INCORPORATED
TARO-CLARITHROMYCIN02361426250 MGTABLET · ORALSUN PHARMA CANADA INC
TARO-CLARITHROMYCIN02361434500 MGTABLET · ORALSUN PHARMA CANADA INC
TARO-CLARITHROMYCIN02390442125 MG / 5 MLPOWDER FOR SUSPENSION · ORALTARO PHARMACEUTICALS INC
TARO-CLARITHROMYCIN02390450250 MG / 5 MLPOWDER FOR SUSPENSION · ORALTARO PHARMACEUTICALS INC
TEVA-CLARITHROMYCIN XL02403196500 MGTABLET (EXTENDED-RELEASE) · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCLARITHROMYCIN 125 MG/5 ML SUS$0.93931per ML23 Sep 2026
US NADACCLARITHROMYCIN 250 MG TABLET$0.39391per EA23 Sep 2026
US NADACCLARITHROMYCIN 250 MG/5 ML SUS$1.34544per ML23 Sep 2026
US NADACCLARITHROMYCIN 250 MG/5 ML SUS$1.56592per ML23 Sep 2026
US NADACCLARITHROMYCIN 500 MG TABLET$0.46583per EA23 Sep 2026
US NADACCLARITHROMYCIN ER 500 MG TAB$1.91822per EA23 Sep 2026
NHS Drug TariffClarithromycin 125mg/5ml oral suspension£12.1070 ml1 Oct 2026
NHS Drug TariffClarithromycin 250mg tablets£1.0314 tablet1 Oct 2026
NHS Drug TariffClarithromycin 250mg/5ml oral suspension£24.8470 ml1 Oct 2026
NHS Drug TariffClarithromycin 500mg modified-release tablets£6.727 tablet1 Oct 2026
NHS Drug TariffClarithromycin 500mg modified-release tablets£13.2314 tablet1 Oct 2026
NHS Drug TariffClarithromycin 500mg tablets£1.9214 tablet1 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)

  • 6.2.2. Watch group antibiotics · core
    First choice: Bacterial pneumonia (Community-acquired pneumonia - severe) (co-prescribed with cefotaxime); First choice: Bacterial pneumonia (Community-acquired pneumonia - severe) (co-prescribed with ceftriaxone); Second choice: Acute pharyngitis; Second choice: Bacterial pneumonia (Community-acquired pneumonia - severe) (co-prescribed with amoxicillin + clavulanic acid); Helicobacter pylori associated gastric ulcer
    Oral > Liquid: 125 mg per 5 mL powder for oral liquid (EML); 250 mg per 5 mL powder for oral liquid (EML) | Parenteral > General injections > unspecified: 500 mg in vial powder for injection (EML) | Oral > Solid > dosage form: 500 mg (EML) | Oral > Liquid: 125 mg per 5 mL powder for oral liquid; 250 mg per 5 mL powder for oral liquid | Parenteral > General injections > unspecified: 500 mg in vial powder for injection | Oral > Solid > dosage form: 500 mg (EML); 250 mg (EMLc) | Oral > Solid > dosage form: 500 mg

Safety signals and safety-related labeling changes

All safety entries for clarithromycin →

Combinations containing Clarithromycin

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.