Active substance
Azithromycin
- SFDA 53
- US FDA 72
- Health Canada 23
- US price lines 8
- NHS prices 7
- WHO EML 2
- Safety 21
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| AZI-ONCE | 40 mg/ml | Powder for oral suspension · Oral use | 1 Bottle | SAR 24.60 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
| AZI-ONCE | 40 mg/ml | Powder for oral suspension · Oral use | 1 Bottle | SAR 33.70 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
| AZI-ONCE | 40 mg/ml | Powder for oral suspension · Oral use | 1 Bottle | SAR 43.60 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
| AZI-ONCE | 250 mg | Capsule · Oral use | 6 Blister | SAR 50.65 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
| AZI-ONCE 500MG F.C.TABLET | 500 mg | Film-coated tablet · Oral use | 3 Blister | SAR 26.40 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
| AZIMAC 250 mg | 250 mg | Film-coated tablet · Oral use | 6 Blister | SAR 50.00 | Generic · Prescription | RIYADH PHARMA | Valid |
| AZIMAC 500 mg | 500 mg | Film-coated tablet · Oral use | 3 Blister | SAR 50.00 | Generic · Prescription | RIYADH PHARMA | Valid |
| AZOLID 250MG F.C. TABLETS | 250 mg | Film-coated tablet · Oral use | 6 Blister | SAR 25.00 | Generic · Prescription | COOPER PHARMA | Valid |
| AZOLID 500MG F.C. TABLETS | 500 mg | Film-coated tablet · Oral use | 3 Blister | SAR 26.40 | Generic · Prescription | COOPER PHARMA | Valid |
| AZOMAX 250MG CAPSULE | 250 mg | Capsule · Oral use | 6 Blister | SAR 32.60 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Valid |
| AZOMYCIN 200MG\5ML SUSP. | 40 mg/ml | Powder for oral suspension · Oral use | 1 Bottle | SAR 24.60 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Valid |
| AZOMYCIN 200MG\5ML SUSP. | 40 mg/ml | Powder for oral suspension · Oral use | 1 Bottle | SAR 43.60 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Valid |
| AZYN 500 mg Film Coated Tablet | 500 mg | Film-coated tablet · Oral use | 3 Blister | SAR 26.40 | Generic · Prescription | BLUEPHARMA GENERICOS,COMERCIO DE MEDICAMENTOS , S.A. | Valid |
| Azithromycin BOS | 500 mg | powder for solution for injection · Intravenous use | 10 Vial | SAR 421.75 | NCE · Prescription | Boston Oncology Arabia | Valid |
| Azitromicina Azevedos | 500 mg | Powder for solution for infusion · Intravenous use | 10 Vial | SAR 211.05 | Generic · Prescription | Laboratorios Azevedos Industria Farmaceutica S.A | Valid |
| Azitromicina Azevedos | 500 mg | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 27.70 | Generic · Prescription | Laboratorios Azevedos Industria Farmaceutica S.A | Valid |
| ZEROX 200MG-5ML POWDER FOR ORAL SUSP. | 40 mg/ml | Suspension · Oral use | 1 Bottle | SAR 9.95 | Generic · Prescription | Hikma Pharmaceuticals PLC | Valid |
| ZEROX 200MG-5ML POWDER FOR ORAL SUSP. | 40 mg/ml | Suspension · Oral use | 1 Bottle | SAR 13.65 | Generic · Prescription | Hikma Pharmaceuticals PLC | Valid |
| ZEROX 500MG F.C. TABLETS | 500 mg | Film-coated tablet · Oral use | 3 Blister | SAR 26.40 | Generic · Prescription | Hikma Pharmaceuticals PLC | Valid |
| ZEROX 500MG F.C. TABLETS | 500 mg | Film-coated tablet · Oral use | 2 Blister | SAR 19.20 | Generic · Prescription | Hikma Pharmaceuticals PLC | Valid |
| ZETRON 200 mg per 5 ml | 40 mg/ml | Powder for oral suspension · Oral use | 1 Bottle | SAR 28.70 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| ZETRON 250 MG CAPSULE | 250 mg | Capsule · Oral use | 6 Blister | SAR 50.00 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| ZETRON 300 per 7.5 ml | 40 mg/ml | Powder for oral suspension · Oral use | 1 Bottle | SAR 39.25 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| ZIMAX 200MG\5ML SUSP | 40 mg/ml | Suspension · Oral use | 1 Bottle | SAR 33.70 | Generic · Prescription | SPIMACO ADDWAEIH | Valid |
| ZIMAX 200MG\5ML SUSP | 40 mg/ml | Suspension · Oral use | 1 Bottle | SAR 24.60 | Generic · Prescription | SPIMACO ADDWAEIH | Valid |
28 more — full table
Indications — CHI Daman Drug Formulary
ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS)-LONG-TERM ORAL ANTIBIOTIC TREATMENT; ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); BACTERIAL SKIN INFECTIONS - IMPETIGO AND ECTHYMA; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - CAMPYLOBACTER INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - SHIGELLA INFECTIONS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - TYPHOID AND PARATYPHOID FEVERS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT - VIBRIO CHOLERAE; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- ENTEROPATHOGENIC ESCHERICHIA COLI; COMMUNITY ACQUIRED PNEUMONEA; CYSTIC FIBROSIS; DENTAL ABSCESS; ENDOCARDITIS; GRAFT VERSUS HOST DISEASE; HUMAN IMMUNODEFICIENCY VIRUS; INFECTIOUS UVEITIS; MUCOPURULENT CONJUCTIVITIS - GONOCOCCAL INFECTION OF THE EYE - CHLAMYDIAL CONJUNCTIVITIS; OTITIS MEDIA; PERICORONITIS; PHARYNGITIS; PREVENTION AND CHEMOPROPHYLAXIS OF BACTERIAL MENINGITIS- MENINGITIS, MENINGOCOCCAL INFECTIONS PREVENTION (CHEMOPROPHYLAXIS); SICKLE CELL DISEASE - ACS MANAGEMENT; SINUSITIS; TRAVEL RELATED INFECTIONS-TREATMENT; URETHRITIS & NONGONOCOCCAL URETHRIIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ZITHROMAX | EQ 100MG BASE/5ML; EQ 200MG BASE/5ML | for suspension · oral | PFIZER | Prescription | 19 Oct 1995 |
| ZITHROMAX | EQ 250MG BASE | tablet · oral | PFIZER | Prescription | 18 Jul 1996 |
| ZITHROMAX | EQ 500MG BASE | tablet · oral | PFIZER | Prescription | 24 May 2002 |
| AZITHROMYCIN | EQ 500MG BASE | tablet · oral | TEVA | Prescription | 14 Nov 2005 |
| AZITHROMYCIN | EQ 600MG BASE | tablet · oral | SANDOZ | Prescription | 14 Nov 2005 |
| AZITHROMYCIN | EQ 250MG BASE | tablet · oral | SANDOZ | Prescription | 14 Nov 2005 |
| AZITHROMYCIN | EQ 500MG BASE | tablet · oral | SANDOZ | Prescription | 14 Nov 2005 |
| AZITHROMYCIN | EQ 600MG BASE | tablet · oral | PLIVA | Prescription | 14 Nov 2005 |
| AZITHROMYCIN | EQ 500MG BASE | tablet · oral | PLIVA | Prescription | 14 Nov 2005 |
| AZITHROMYCIN | EQ 250MG BASE | tablet · oral | PLIVA | Prescription | 14 Nov 2005 |
| AZITHROMYCIN | EQ 500MG BASE/VIAL | injectable · injection | FRESENIUS KABI USA | Prescription | 13 Dec 2005 |
| AZITHROMYCIN | EQ 200MG BASE/5ML; EQ 100MG BASE/5ML | for suspension · oral | PLIVA | Prescription | 6 Jul 2006 |
| AZASITE | 1% | solution/drops · ophthalmic | THEA PHARMA | Prescription | 27 Apr 2007 |
| AZITHROMYCIN | EQ 600MG BASE | tablet · oral | CHARTWELL RX | Prescription | 11 Feb 2008 |
| AZITHROMYCIN | EQ 250MG BASE | tablet · oral | CHARTWELL RX | Prescription | 11 Feb 2008 |
| AZITHROMYCIN | EQ 500MG BASE | tablet · oral | CHARTWELL RX | Prescription | 11 Feb 2008 |
| AZITHROMYCIN | EQ 500MG BASE/VIAL | injectable · injection | HOSPIRA | Prescription | 26 Jun 2009 |
| AZITHROMYCIN | EQ 500MG BASE/VIAL | injectable · injection | GLAND PHARMA LTD | Prescription | 9 Nov 2009 |
| AZITHROMYCIN | EQ 250MG BASE | tablet · oral | LUPIN | Prescription | 15 May 2015 |
| AZITHROMYCIN | EQ 500MG BASE | tablet · oral | LUPIN | Prescription | 15 May 2015 |
| AZITHROMYCIN | EQ 600MG BASE | tablet · oral | LUPIN | Prescription | 15 May 2015 |
| AZITHROMYCIN | EQ 100MG BASE/5ML; EQ 200MG BASE/5ML | for suspension · oral | CHARTWELL RX | Prescription | 15 May 2015 |
| AZITHROMYCIN | EQ 500MG BASE/VIAL | injectable · injection | EUGIA PHARMA | Prescription | 19 Jun 2015 |
| AZITHROMYCIN | EQ 100MG BASE/5ML; EQ 200MG BASE/5ML | for suspension · oral | EPIC PHARMA LLC | Prescription | 9 Apr 2018 |
| AZITHROMYCIN | EQ 250MG BASE | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 5 Jul 2018 |
47 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AG-AZITHROMYCIN | 02480700 | 250 MG | TABLET · ORAL | ANGITA PHARMA INC. |
| APO-AZITHROMYCIN Z | 02415542 | 250 MG | TABLET · ORAL | APOTEX INC |
| AURO-AZITHROMYCIN | 02482363 | 100 MG / 5 ML | POWDER FOR SUSPENSION · ORAL | AURO PHARMA INC |
| AURO-AZITHROMYCIN | 02482371 | 200 MG / 5 ML | POWDER FOR SUSPENSION · ORAL | AURO PHARMA INC |
| AZITHROMYCIN | 02330881 | 250 MG | TABLET · ORAL | SANIS HEALTH INC |
| AZITHROMYCIN | 02442434 | 250 MG | TABLET · ORAL | SIVEM PHARMACEUTICALS ULC |
| AZITHROMYCIN | 02545969 | 250 MG | TABLET · ORAL | 10445517 CANADA INC / NORTH PHARMACEUTICALS / DAC PHARMACEUTICALS |
| AZITHROMYCIN FOR INJECTION | 02523825 | 500 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | JAMP PHARMA CORPORATION |
| AZITHROMYCIN FOR INJECTION | 02524449 | 500 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | GENERIC MEDICAL PARTNERS INC |
| AZITHROMYCIN FOR INJECTION USP | 02483890 | 500 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | STERIMAX INC |
| AZITHROMYCIN FOR INJECTION, USP | 02465604 | 500 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | AURO PHARMA INC |
| AZITHROMYCIN FOR INJECTION, USP | 02531429 | 500 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | EUGIA PHARMA INC. |
| JAMP-AZITHROMYCIN | 02452308 | 250 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| M-AZITHROMYCIN | 02502038 | 250 MG | TABLET · ORAL | MANTRA PHARMA INC |
| MAR-AZITHROMYCIN | 02452324 | 250 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| NRA-AZITHROMYCIN | 02479680 | 250 MG | TABLET · ORAL | NORA PHARMA INC |
| PMS-AZITHROMYCIN | 02261634 | 250 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PRO-AZITHROMYCINE | 02310600 | 250 MG | TABLET · ORAL | PRO DOC LIMITEE |
| RIVA-AZITHROMYCIN | 02275309 | 250 MG | TABLET · ORAL | LABORATOIRE RIVA INC. |
| SANDOZ AZITHROMYCIN | 02265826 | 250 MG | TABLET · ORAL | SANDOZ CANADA INCORPORATED |
| SANDOZ AZITHROMYCIN | 02332388 | 100 MG / 5 ML | POWDER FOR SUSPENSION · ORAL | SANDOZ CANADA INCORPORATED |
| SANDOZ AZITHROMYCIN | 02332396 | 200 MG / 5 ML | POWDER FOR SUSPENSION · ORAL | SANDOZ CANADA INCORPORATED |
| TEVA-AZITHROMYCIN | 02267845 | 250 MG | TABLET · ORAL | TEVA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | AZASITE 1% EYE DROPS | $98.5088 | per ML | 23 Sep 2026 |
| US NADAC | AZITHROMYCIN 100 MG/5 ML SUSP | $0.37021 | per ML | 23 Sep 2026 |
| US NADAC | AZITHROMYCIN 200 MG/5 ML SUSP | $0.28536 | per ML | 23 Sep 2026 |
| US NADAC | AZITHROMYCIN 200 MG/5 ML SUSP | $0.20465 | per ML | 23 Sep 2026 |
| US NADAC | AZITHROMYCIN 200 MG/5 ML SUSP | $0.23793 | per ML | 23 Sep 2026 |
| US NADAC | AZITHROMYCIN 250 MG TABLET | $0.26557 | per EA | 23 Sep 2026 |
| US NADAC | AZITHROMYCIN 500 MG TABLET | $0.54094 | per EA | 23 Sep 2026 |
| US NADAC | AZITHROMYCIN 600 MG TABLET | $0.71481 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Azithromycin 15mg/g eye drops 0.25g unit dose preservative free | £6.99 | 6 unit dose | 1 Oct 2026 |
| NHS Drug Tariff | Azithromycin 200mg/5ml oral suspension | £4.06 | 15 ml | 1 Oct 2026 |
| NHS Drug Tariff | Azithromycin 200mg/5ml oral suspension | £6.10 | 22.5 ml | 1 Oct 2026 |
| NHS Drug Tariff | Azithromycin 200mg/5ml oral suspension | £11.04 | 30 ml | 1 Oct 2026 |
| NHS Drug Tariff | Azithromycin 250mg capsules | £1.14 | 6 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Azithromycin 250mg tablets | £0.72 | 4 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Azithromycin 500mg tablets | £0.92 | 3 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)
- 6.2.2. Watch group antibiotics · core
First choice: Cholera; First choice: Cholera [children]; First choice: Paratyphoid fever; First choice: Chlamydia trachomatis; First choice: Typhoid fever; First choice: Yaws; First choice: Trachoma; First choice: Gonococcal infection (co-prescribed with ceftriaxone); Second choice: Infectious gastroenteritis or colitis without specification of infectious agent; Second choice: Gonococcal infection (co-prescribed with cefixime)
Oral > Liquid: 200 mg per 5 mL (anhydrous) powder for oral liquid (EMLc) | Oral > Solid > dosage form: 250 mg (anhydrous); 500 mg (anhydrous) | Oral > Liquid: 200 mg per 5 mL (anhydrous) powder for oral liquid - 21.1. Ophthalmological preparations > Anti-infective agents · core
Trachoma
Local > Ophthalmological > Solution (eye drops): 1.5% eye drops
Safety signals and safety-related labeling changes
- US FDA 13 Jul 2026 ZITHROMAX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Jul 2026 ZITHROMAX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Jul 2026 ZITHROMAX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Jul 2026 ZITHROMAX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Jul 2026 ZITHROMAX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 13 Jul 2026 ZITHROMAX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 25 Jul 2024 AZASITE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations - US FDA 22 Nov 2021 ZITHROMAX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Nov 2021 ZMAX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 13 Feb 2020 PRAC signal: Increased cancer risk among patients with bronchiolitis obliterans after hematopoietic cell transplantation
Action for MAH: update of the product information: No - EMA PRAC 12 Apr 2018 PRAC signal: Increased rate of relapses of haematological malignancies and mortality in hematopoietic stem cell transplantation (HSCT) patients
Action for MAH: update of the product information: No - EMA PRAC 29 Sep 2017 PRAC signal: Acute generalised exanthematous pustulosis (AGEP)
Action for MAH: update of the product information: Yes - EMA PRAC 1 Sep 2017 PRAC signal: Increased rate of relapses of haematological malignancies and mortality in hematopoietic stem cell transplantation (HSCT) patients
Action for MAH: update of the product information: No - EMA PRAC 1 Sep 2017 PRAC signal: Possible interaction between tobramycin and azithromycin leading to lower effectiveness of tobramycin
Action for MAH: update of the product information: No - EMA PRAC 5 May 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.