ZITHROMAX

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

Active ingredients

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

1	Azithromycin 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

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
04-1387	Powder for suspension	Zithromax Powder for Oral Suspension PWD_F_SOL 200 mg/5 mL 15 mL (in HDPE bottle)	Powder for Oral Suspension. Dry powder which yields, on reconstitution with water, a white to off-white suspension containing the equivalent of 200 mg azithromycin per 5 mL	30/11/2020
04-1388	Capsule	Zithromax Capsules 250 mg CAP 250 mg 1 x 6's (in PVC blister)	Capsules for oral administration. Plain white No. 0 hard gelatin capsules containing Azithromycin dihydrate equivalent to 250 mg Azithromycin	30/11/2020
04-6155	Powder for injection	Zithromax IV 500 mg Injection INJ_PWD 500 mg 1 x 1's (in 10 mL Type I flint glass tubular vial)	Powder for solution for IV injection. Azithromycin is supplied in a lyophilized form under a vacuum in a 10 mL vial equivalent to 500 mg Azithromycin for IV administration. Upon reconstitution, Azithromycin powder yields a solution containing the equivalent of 100 mg Azithromycin per 1 mL	24/06/2021

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
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