Azithromycin (Page 8 of 8)

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AZITHROMYCIN
azithromycin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-536(NDC:50111-787)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN MONOHYDRATE (AZITHROMYCIN ANHYDROUS) AZITHROMYCIN ANHYDROUS 250 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 4000
TRISODIUM CITRATE DIHYDRATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL Size 15mm
Flavor Imprint Code PLIVA;787
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45865-536-06 1 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (45865-536-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065225 01/06/2006
Labeler — Medsource Pharmaceuticals (833685915)
Establishment
Name Address ID/FEI Operations
Medsource Pharmaceuticals 833685915 relabel (45865-536)

Revised: 09/2015 Medsource Pharmaceuticals

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