Ziprasidone

ZIPRASIDONE- ziprasidone hydrochloride capsule
Zydus Lifesciences Limited

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1179-6

Ziprasidone capsules, 20 mg

60 Capsules

Rx only

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NDC 70771-1180-6

Ziprasidone capsules, 40 mg

60 Capsules

Rx only

Image
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NDC 70771-1181-6

Ziprasidone capsules, 60 mg

60 Capsules

Rx only

Image
(click image for full-size original)

NDC 70771-1182-6

Ziprasidone capsules, 80 mg

60 Capsules

Rx only

Image
(click image for full-size original)
ZIPRASIDONE
ziprasidone capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1179
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
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (DARK BLUE OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code 237
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1179-6 60 CAPSULE in 1 BOTTLE None
2 NDC:70771-1179-5 500 CAPSULE in 1 BOTTLE None
3 NDC:70771-1179-8 8 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1179-2)
3 NDC:70771-1179-2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (70771-1179-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208988 12/28/2017
ZIPRASIDONE
ziprasidone capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1180
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
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (DARK BLUE OPAQUE CAP) , BLUE (LIGHT BLUE OPAQUE BODY) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 240
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1180-6 60 CAPSULE in 1 BOTTLE None
2 NDC:70771-1180-5 500 CAPSULE in 1 BOTTLE None
3 NDC:70771-1180-8 8 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1180-2)
3 NDC:70771-1180-2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (70771-1180-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208988 12/28/2017
ZIPRASIDONE
ziprasidone capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1181
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
FERROSOFERRIC OXIDE
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE OPAQUE CAP) , WHITE (WHITE OPAQUE BODY) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code 239
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1181-6 60 CAPSULE in 1 BOTTLE None
2 NDC:70771-1181-5 500 CAPSULE in 1 BOTTLE None
3 NDC:70771-1181-8 8 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1181-2)
3 NDC:70771-1181-2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (70771-1181-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208988 12/28/2017
ZIPRASIDONE
ziprasidone capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1182
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
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (DARK BLUE OPAQUE CAP) , BLUE (LIGHT BLUE OPAQUE BODY) Score no score
Shape CAPSULE (CAPSULE) Size 16mm
Flavor Imprint Code 238
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1182-6 60 CAPSULE in 1 BOTTLE None
2 NDC:70771-1182-5 500 CAPSULE in 1 BOTTLE None
3 NDC:70771-1182-8 8 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1182-2)
3 NDC:70771-1182-2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (70771-1182-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208988 12/28/2017
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 863362789 ANALYSIS (70771-1179), ANALYSIS (70771-1180), ANALYSIS (70771-1181), ANALYSIS (70771-1182), MANUFACTURE (70771-1179), MANUFACTURE (70771-1180), MANUFACTURE (70771-1181), MANUFACTURE (70771-1182)

Revised: 10/2023 Zydus Lifesciences Limited

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