Ziprasidone Hydrochloride (Page 9 of 9)

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ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64725-2164(NDC:0781-2164)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE) ZIPRASIDONE 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SILICATE
CITRIC ACID MONOHYDRATE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
STARCH, CORN
FD&C BLUE NO. 2
GELATIN
FERRIC OXIDE YELLOW
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
CARBOXYMETHYLCELLULOSE
Product Characteristics
Color YELLOW (opaque yellow cap) , BLUE (opaque blue body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code SZ;656
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64725-2164-1 30 CAPSULE in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077562 02/13/2013
ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64725-2168(NDC:0781-2168)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE (ZIPRASIDONE) ZIPRASIDONE 80 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SILICATE
CITRIC ACID MONOHYDRATE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
STARCH, CORN
FD&C BLUE NO. 2
GELATIN
FERRIC OXIDE YELLOW
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
CARBOXYMETHYLCELLULOSE
Product Characteristics
Color YELLOW (opaque yellow cap) , BLUE (opaque blue body) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code SZ;659
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64725-2168-1 30 CAPSULE in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077562 02/13/2013
Labeler — TYA Pharmaceuticals (938389038)
Registrant — TYA Pharmaceuticals (938389038)
Establishment
Name Address ID/FEI Operations
TYA Pharmaceuticals 938389038 RELABEL (64725-2164), REPACK (64725-2164), RELABEL (64725-2168)

Revised: 08/2013 TYA Pharmaceuticals

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