Azithromycin Dihydrate (Page 8 of 8)

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AZITHROMYCIN DIHYDRATE azithromycin dihydrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-859(NDC:51224-022)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Azithromycin Dihydrate (Azithromycin anhydrous) Azithromycin anhydrous 250 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
FD&C BLUE NO. 1
Lecithin, soybean
FD&C RED NO. 40
FD&C YELLOW NO. 6
polyethylene glycol 3350
magnesium stearate
polyvinyl alcohol, unspecified
STARCH, CORN
talc
titanium dioxide
Product Characteristics
Color RED Score no score
Shape OVAL Size 13mm
Flavor Imprint Code OE;250
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55700-859-06 6 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208250 05/01/2020
Labeler — Quality Care Products, LLC (831276758)
Establishment
Name Address ID/FEI Operations
Quality Care Products, LLC 831276758 relabel (55700-859)

Revised: 04/2023 Quality Care Products, LLC

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