Amoxicillin (Page 6 of 6)

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AMOXICILLIN amoxicillin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64725-0017(NDC:65862-017)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color BLUE, PINK Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code A45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64725-0017-1 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065271 11/09/2005
Labeler — TYA Pharmaceuticals (938389038)
Registrant — TYA Pharmaceuticals (938389038)
Establishment
Name Address ID/FEI Operations
TYA Pharmaceuticals 938389038 RELABEL (64725-0017), REPACK (64725-0017)

Revised: 01/2014 TYA Pharmaceuticals

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