NDC Code(s) : 0069-4170-34
Packager : Pfizer Laboratories Div Pfizer Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ZMAXazithromycin dihydrate POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-4170
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN DIHYDRATE(UNII: 5FD1131I7S)
(AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M) 		AZITHROMYCIN ANHYDROUS2 g in 60 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
POLOXAMER 407(UNII: TUF2IVW3M2)
SUCROSE(UNII: C151H8M554)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS(UNII: SX01TZO3QZ)
MAGNESIUM HYDROXIDE(UNII: NBZ3QY004S)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
XANTHAN GUM(UNII: TTV12P4NEE)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color Score
Shape Size
Flavor CHERRY, BANANA Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-4170-341 in 1 CARTON 10/06/1995
160 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050797 06/10/1995

PRINCIPAL DISPLAY PANEL

Rx only
NDC 0069-4170-34

Zmax ®
(azithromycin
extended release)
for oral suspension

2 g

Cherry-Banana Flavored

Pfizer

Distributed by
Pfizer Labs
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL - 2 g Bottle Label

PRINCIPAL DISPLAY PANEL

single use 2g bottle
NDC 0069-4170-34

Rx only

Zmax ®
(azithromycin
extended release)
for oral suspension

2 g

Cherry-Banana Flavored

FOR ORAL USE ONLY

PRINCIPAL DISPLAY PANEL - 2 g Bottle Carton