ZITHROMAX

This brand name is authorized in United States. It is also authorized in Australia, Austria, Canada, Cyprus, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Malta, Netherlands, New Zealand, Nigeria, Singapore, South Africa, Tunisia, UK.

Active ingredients

The drug ZITHROMAX contains one active pharmaceutical ingredient (API):

1
UNII 5FD1131I7S - AZITHROMYCIN DIHYDRATE
 

Azithromycin is a macrolide antibiotic belonging to the azalide group. The molecule is constructed by adding a nitrogen atom to the lactone ring of erythromycin A. The mechanism of action of azithromycin is based upon the suppression of bacterial protein synthesis by means of binding to the ribosomal 50S sub-unit and inhibition of peptide translocation.

 
Read more about Azithromycin

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 ZITHROMAX Capsule, hard MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)
 ZITHROMAX Powder for solution for injection MPI, US: SPL/PLR FDA, National Drug Code (US)
 ZITHROMAX Film-coated tablet / Powder for suspension MPI, US: SPL/PLR FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
J01FA10 Azithromycin J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01F Macrolides, lincosamides and streptogramins → J01FA Macrolides
Discover more medicines within J01FA10

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 4115N, 5616N, 6221K, 8200N, 8201P, 8336R
CA Health Products and Food Branch 02212021, 02223716, 02223724, 02239952
DE Bundesinstitut für Arzneimittel und Medizinprodukte 00010760, 02481966, 04678503, 07130987
FI Lääkealan turvallisuus- ja kehittämiskeskus 003742, 039776, 039784, 389452, 389460
FR Base de données publique des médicaments 62059468, 65740799, 67287098, 68175764
GB Medicines & Healthcare Products Regulatory Agency 139916, 164513, 19151, 19153, 19156, 19157, 19158, 375776, 381770, 381772, 381773
HK Department of Health Drug Office 36432, 44360, 44814, 45614
IE Health Products Regulatory Authority 59900, 59919, 91953, 91979
IL מִשְׂרַד הַבְּרִיאוּת 8658
MT Medicines Authority MA505/03901, MA505/03902, PI1438/09901A, PI770/13801A, PI908/07601C, PI908/07602A
NG Registered Drug Product Database 04-1387, 04-1388, 04-6155
Switch country to Nigeria in order to find specific presentations of ZITHROMAX
NL Z-Index G-Standaard 13810707
NL Z-Index G-Standaard, PRK 114995, 115002, 115010
NZ Medicines and Medical Devices Safety Authority 10223, 6161, 6162, 6163, 6164
SG Health Sciences Authority 07863P, 10720P, 10721P, 10911P, 12057P
TN Direction de la Pharmacie et du Médicament 6043171, 9243053, 9243054, 9243055, 9243056
US FDA, National Drug Code 0069-0400, 0069-3051, 0069-3060, 0069-3070, 0069-3110, 0069-3120, 0069-3130, 0069-3140, 0069-3150, 0069-4061, 50090-0603, 61919-555, 70518-0336, 70518-0505
ZA Health Products Regulatory Authority 27/20.1.1/0279, 31/20.1.1/0045, 36/20.1.1/0190, A40/20.1.1/0102

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