Ziprasidone Hydrochloride (Page 11 of 11)

PRINCIPAL DISPLAY PANEL — 20 mg BOTTLE

APOTEX CORP. NDC 60505-2528-6

Ziprasidone Capsules, USP

20 mg

Rx

60 bottle count

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PRINCIPAL DISPLAY PANEL — 40 mg BOTTLE

APOTEX CORP. NDC 60505-2529-6

Ziprasidone Capsules, USP

40 mg

Rx

60 bottle count

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PRINCIPAL DISPLAY PANEL — 60 mg BOTTLE

APOTEX CORP. NDC 60505-2530-6

Ziprasidone Capsules , USP

60 mg

Rx

60 bottle count

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PRINCIPAL DISPLAY PANEL — 80 mg BOTTLE

APOTEX CORP. NDC 60505-2531-6

Ziprasidone Capsules, USP

80 mg

Rx

60 bottle count

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ZIPRASIDONE HYDROCHLORIDE ziprasidone hcl capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-2528
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
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color PURPLE (purple body) , WHITE (white cap) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code APO;ZIP;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-2528-3 30 CAPSULE in 1 BOTTLE None
2 NDC:60505-2528-6 60 CAPSULE in 1 BOTTLE None
3 NDC:60505-2528-8 1000 CAPSULE in 1 BOTTLE None
4 NDC:60505-2528-0 8 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (60505-2528-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077561 05/14/2012
ZIPRASIDONE HYDROCHLORIDE ziprasidone hcl capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-2529
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE (Ziprasidone) Ziprasidone 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color PURPLE (purple body) , PURPLE (purple cap) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code APO;ZIP;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-2529-3 30 CAPSULE in 1 BOTTLE None
2 NDC:60505-2529-6 60 CAPSULE in 1 BOTTLE None
3 NDC:60505-2529-8 1000 CAPSULE in 1 BOTTLE None
4 NDC:60505-2529-0 8 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (60505-2529-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077561 05/14/2012
ZIPRASIDONE HYDROCHLORIDE ziprasidone hcl capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-2530
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIPRASIDONE HYDROCHLORIDE (Ziprasidone) Ziprasidone 60 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color WHITE (white body) , WHITE (white cap) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code APO;ZIP;60
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-2530-3 30 CAPSULE in 1 BOTTLE None
2 NDC:60505-2530-6 60 CAPSULE in 1 BOTTLE None
3 NDC:60505-2530-8 1000 CAPSULE in 1 BOTTLE None
4 NDC:60505-2530-0 8 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (60505-2530-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077561 05/14/2012
ZIPRASIDONE HYDROCHLORIDE ziprasidone hcl capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-2531
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
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color PURPLE (purple body) , WHITE (white cap) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code APO;ZIP;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-2531-3 30 CAPSULE in 1 BOTTLE None
2 NDC:60505-2531-6 60 CAPSULE in 1 BOTTLE None
3 NDC:60505-2531-8 1000 CAPSULE in 1 BOTTLE None
4 NDC:60505-2531-0 8 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (60505-2531-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077561 05/14/2012
Labeler — Apotex Corp. (845263701)
Registrant — Apotex Inc. (209429182)

Revised: 06/2021 Apotex Corp.

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