ZITHROMAX Film-coated tablet / Powder for suspension Ref.[10631] Active ingredients: Azithromycin

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

ZITHROMAX (azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)13[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00.

Azithromycin has the following structural formula:

Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12∙2H2O and a molecular weight of 785.0.

ZITHROMAX is supplied as tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide, triacetin, and D&C Red #30 aluminum lake.

ZITHROMAX for oral suspension is supplied in bottles containing azithromycin dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla, and banana flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.

Dosage Forms and Strengths

ZITHROMAX 250 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin. ZITHROMAX 250 mg tablets are engraved with “PFIZER” on one side and “306” on the other, or “Pfizer” on one side and “ZTM 250” on the other. These are packaged in bottles and blister cards of 6 tablets (Z-PAKS).

ZITHROMAX 500 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 500 mg of azithromycin. ZITHROMAX 500 mg tablets are engraved with “Pfizer” on one side and “ZTM500” on the other. These are packaged in bottles and blister cards of 3 tablets (TRI-PAKS).

ZITHROMAX for oral suspension after constitution contains a flavored suspension. ZITHROMAX for oral suspension is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles.

How Supplied

ZITHROMAX is supplied in the following strengths and package configurations:

Tablet strength Tablet Color/Shape Tablet Markings Package Size NDC Code
250 mg
(containing azithromycin dihydrate equivalent to 250 mg of azithromycin)
Pink modified capsular shaped, engraved, film-coated Engraved with “PFIZER” on one side and “306” on the otherBottles of 30NDC 0069-3060-30
Boxes of 3 (Z-PAKS of 6) NDC 0069-3060-75
Unit Dose package of 50 NDC 0069-3060-86
Engraved with “Pfizer” on one side and “ZTM 250” on the other Bottles of 30 NDC 0069-4061-01
Boxes of 3 (Z-PAKS of 6) NDC 0069-4061-75
Unit Dose package of 50 NDC 0069-4061-89
500 mg
(containing azithromycin dihydrate equivalent to 500 mg of azithromycin)
Pink modified capsular shaped, engraved, film coated Engraved with “Pfizer” on one side and “ZTM500” on the other Bottles of 30 NDC 0069-3070-30
Boxes of 3 (TRI-PAKS of 3 tablets) NDC 0069-3070-75
Unit Dose package of 50 NDC 0069-3070-86

ZITHROMAX tablets should be stored between 15° to 30°C (59° to 86°F).

ZITHROMAX for oral suspension after constitution contains a flavored suspension. ZITHROMAX for oral suspension is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows:

Azithromycin contents per bottle NDC
300 mg 0069-3110-19
600 mg 0069-3120-19
900 mg 0069-3130-19
1200 mg 0069-3140-19

[see Dosage and Administration (2)] for constitution instructions with each bottle type.

Drugs

Drug Countries
ZITHROMAX Austria, Australia, Canada, Cyprus, Germany, Finland, France, Hong Kong, Ireland, Israel, Malta, Nigeria, Netherlands, New Zealand, Singapore, Tunisia, United Kingdom, United States, South Africa

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