Ziprasidone Hydrochloride: Package Insert and Label Information (Page 7 of 7)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg (60 Capsules Bottle)

NDC 68001-450-06
Rx only
Ziprasidone
Capsules USP
20 mg BluePoint Laboratories 60 Capsules

Ziprasidone Capsules USP 20mg (60 Capsules Bottle) NDC 68001-450-06
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg (60 Capsules Bottle)

NDC 68001-451-06
Rx only
Ziprasidone Capsules USP
40 mg
BluePoint Laboratories 60 Capsules

Ziprasidone Capsules USP 40mg (60 Capsules Bottle) NDC 68001-451-06
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 60 mg (60 Capsules Bottle)

NDC 68001-452-06
Rx only
Ziprasidone Capsules USP
60 mg
BluePoint Laboratories 60 Capsules

Ziprasidone Capsules USP 60mg (60 Capsule Bottle) NDC 68001-452-06
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 80 mg (60 Capsules Bottle)

NDC 68001-453-06
Rx only
Ziprasidone Capsules USP
80 mg BluePoint Laboratories 60 Capsules

Ziprasidone Capsules USP 80mg (60 Capsule Bottle) NDC68001-453-06
(click image for full-size original)
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-450
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
ETHYLCELLULOSE (10 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SHELLAC
AMMONIA
Product Characteristics
Color blue (Blue Opaque) , white (Off-white Opaque) Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code F;26
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-450-06 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204117 08/31/2020
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-451
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
ETHYLCELLULOSE (10 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SHELLAC
AMMONIA
Product Characteristics
Color blue (Blue Opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code F;38
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-451-06 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204117 08/31/2020
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-452
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
ETHYLCELLULOSE (10 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SHELLAC
AMMONIA
Product Characteristics
Color white (Off-white Opaque) Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code F;39
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-452-06 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204117 08/31/2020
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-453
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
ETHYLCELLULOSE (10 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SHELLAC
AMMONIA
Product Characteristics
Color blue (Blue Opaque) , white (Of-white Opaque) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code X;66
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-453-06 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204117 08/31/2020
Labeler — BluePoint Laboratories (985523874)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 analysis (68001-450), analysis (68001-451), analysis (68001-452), analysis (68001-453), manufacture (68001-450), manufacture (68001-451), manufacture (68001-452), manufacture (68001-453)

Revised: 06/2022 BluePoint Laboratories

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