NDC Code(s) : 55154-3342-0, 55154-3343-0, 55154-3384-0, 55154-3344-0
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ziprasidone HydrochlorideZiprasidone Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-3342(NDC:0904-6269)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE(UNII: 216X081ORU)
(ZIPRASIDONE - UNII:6UKA5VEJ6X) 		ZIPRASIDONE20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONES(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
1-PROPOXY-2-PROPANOL(UNII: 152BY1743W)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
GELATIN(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK (Light pink to brown) Score no score
Shape CAPSULE Size 4 mm
Flavor Imprint Code RDY;256
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-3342-010 in 1 BAG
11 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077565 03/15/2012
Ziprasidone HydrochlorideZiprasidone Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-3343(NDC:0904-6270)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE(UNII: 216X081ORU)
(ZIPRASIDONE - UNII:6UKA5VEJ6X) 		ZIPRASIDONE40 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONES(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
GELATIN(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PHENOXYISOPROPANOL(UNII: 87CZY0NY1A)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color PINK (Light pink to brown) Score no score
Shape CAPSULE Size 4 mm
Flavor Imprint Code RDY;257
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-3343-010 in 1 BAG
11 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077565 03/15/2012
Ziprasidone HydrochlorideZiprasidone Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-3384(NDC:0904-6271)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE(UNII: 216X081ORU)
(ZIPRASIDONE - UNII:6UKA5VEJ6X) 		ZIPRASIDONE60 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONES(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PHENOXYISOPROPANOL(UNII: 87CZY0NY1A)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color PINK (light pink to brown) Score no score
Shape CAPSULE Size 3 mm
Flavor Imprint Code RDY;258
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-3384-010 in 1 BAG
11 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077565 03/15/2012
Ziprasidone HydrochlorideZiprasidone Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-3344(NDC:0904-6272)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE(UNII: 216X081ORU)
(ZIPRASIDONE - UNII:6UKA5VEJ6X) 		ZIPRASIDONE80 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONES(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
GELATIN(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PHENOXYISOPROPANOL(UNII: 87CZY0NY1A)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color PINK (light pink to brown) Score no score
Shape CAPSULE Size 2 mm
Flavor Imprint Code RDY;259
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-3344-010 in 1 BAG
11 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077565 03/15/2012

PRINCIPAL DISPLAY PANEL

Ziprasidone Hydrochloride

Capsules 20 mg*

10 Capsules

bag label

PRINCIPAL DISPLAY PANEL

Ziprasidone Hydrochloride

Capsules 40 mg*

10 Capsules

bag label

PRINCIPAL DISPLAY PANEL

Ziprasidone Hydrochloride

Capsules 60 mg*

10 Capsules

bag label

PRINCIPAL DISPLAY PANEL

Ziprasidone Hydrochloride

Capsules 80 mg*

10 Capsules

bag label