Ziprasidone Hydrochloride (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Ziprasidone Hydrochloride

GENERIC: Ziprasidone Hydrochloride

DOSAGE: Capsules

ADMINSTRATION: Oral

NDC: 64679-991-01

STRENGTH: 20 mg

COLOR: White Cap, White Body

SHAPE: Capsule

SCORE: no score

SIZE: 14 mm

IMPRINT: W991

QTY: 30 Capsules

20 mg
(click image for full-size original)

DRUG: Ziprasidone Hydrochloride

GENERIC: Ziprasidone Hydrochloride

DOSAGE: Capsules

ADMINSTRATION: Oral

NDC: 64679-992-02

STRENGTH: 40 mg

COLOR: Blue Cap, White Body

SHAPE: Capsule

SCORE: no score

SIZE: 16 mm

IMPRINT: W992

QTY: 60 Capsules

40 mg
(click image for full-size original)

DRUG: Ziprasidone Hydrochloride

GENERIC: Ziprasidone Hydrochloride

DOSAGE: Capsules

ADMINSTRATION: Oral

NDC: 64679-993-03

STRENGTH: 60 mg

COLOR: Pink Cap, White Body

SHAPE: Capsule

SCORE: no score

SIZE: 18 mm

IMPRINT: W993

QTY: 100 Capsules

60 mg
(click image for full-size original)

DRUG: Ziprasidone Hydrochloride

GENERIC: Ziprasidone Hydrochloride

DOSAGE: Capsules

ADMINSTRATION: Oral

NDC: 64679-994-04

STRENGTH: 80 mg

COLOR: Blue Cap, Blue Body

SHAPE: Capsule

SCORE: no score

SIZE: 19 mm

IMPRINT: W994

QTY: 500 Capsules

80 mg
(click image for full-size original)
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-991
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
CELLULOSE, MICROCRYSTALLINE
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (cap) , WHITE (body) Score no score
Shape CAPSULE (size 4 hard gelatin capsule) Size 14mm
Flavor Imprint Code W991
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-991-01 30 CAPSULE in 1 BOTTLE None
2 NDC:64679-991-02 60 CAPSULE in 1 BOTTLE None
3 NDC:64679-991-03 100 CAPSULE in 1 BOTTLE None
4 NDC:64679-991-04 500 CAPSULE in 1 BOTTLE None
5 NDC:64679-991-06 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 8 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (64679-991-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090348 09/01/2012
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-992
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
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 1
FD&C RED NO. 3
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (cap) , WHITE (body) Score no score
Shape CAPSULE (size 3 hard gelatin capsule) Size 16mm
Flavor Imprint Code W992
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-992-01 30 CAPSULE in 1 BOTTLE None
2 NDC:64679-992-02 60 CAPSULE in 1 BOTTLE None
3 NDC:64679-992-03 100 CAPSULE in 1 BOTTLE None
4 NDC:64679-992-04 500 CAPSULE in 1 BOTTLE None
5 NDC:64679-992-06 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 8 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (64679-992-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090348 09/01/2012
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-993
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
CELLULOSE, MICROCRYSTALLINE
D&C RED NO. 28
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color PINK (cap) , WHITE (body) Score no score
Shape CAPSULE (size 2 hard gelatin capsule) Size 18mm
Flavor Imprint Code W993
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-993-01 30 CAPSULE in 1 BOTTLE None
2 NDC:64679-993-02 60 CAPSULE in 1 BOTTLE None
3 NDC:64679-993-03 100 CAPSULE in 1 BOTTLE None
4 NDC:64679-993-04 500 CAPSULE in 1 BOTTLE None
5 NDC:64679-993-06 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 8 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (64679-993-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090348 09/01/2012
ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64679-994
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
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 1
FD&C RED NO. 3
GELATIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BLUE (cap) , BLUE (body) Score no score
Shape CAPSULE (size 1 hard gelatin capsule) Size 19mm
Flavor Imprint Code W994
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-994-01 30 CAPSULE in 1 BOTTLE None
2 NDC:64679-994-02 60 CAPSULE in 1 BOTTLE None
3 NDC:64679-994-03 100 CAPSULE in 1 BOTTLE None
4 NDC:64679-994-04 500 CAPSULE in 1 BOTTLE None
5 NDC:64679-994-06 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
5 8 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (64679-994-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090348 09/01/2012
Labeler — Wockhardt USA LLC. (170508365)
Registrant — Wockhardt Limited (650069115)
Establishment
Name Address ID/FEI Operations
Wockhardt Limited 676257570 ANALYSIS (64679-991), ANALYSIS (64679-992), ANALYSIS (64679-993), ANALYSIS (64679-994), MANUFACTURE (64679-991), MANUFACTURE (64679-992), MANUFACTURE (64679-993), MANUFACTURE (64679-994), LABEL (64679-991), LABEL (64679-992), LABEL (64679-993), LABEL (64679-994), PACK (64679-991), PACK (64679-992), PACK (64679-993), PACK (64679-994)

Revised: 11/2019 Wockhardt USA LLC.

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