NDC Code(s) : 51079-351-01, 51079-351-16, 51079-352-01, 51079-352-16, 51079-353-01, 51079-353-16, 51079-354-01, 51079-354-16
Packager : Mylan Institutional Inc.

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:51079-351(NDC:0378-7350)
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color blue (blue opaque), white (white opaque) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code MYLAN;ZE;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-351-1660 in 1 CARTON 30/09/2014
1NDC:51079-351-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202395 09/30/2014 07/31/2017
Ziprasidone Hydrochlorideziprasidone hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-352(NDC:0378-7351)
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color blue (blue opaque) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code MYLAN;ZE;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-352-1660 in 1 CARTON 30/09/2014
1NDC:51079-352-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202395 09/30/2014 01/31/2018
Ziprasidone Hydrochlorideziprasidone hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-353(NDC:0378-7352)
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white opaque) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code MYLAN;ZE;60
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-353-1660 in 1 CARTON 30/09/2014
1NDC:51079-353-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202395 09/30/2014 02/28/2018
Ziprasidone Hydrochlorideziprasidone hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-354(NDC:0378-7353)
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
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLACRILIN POTASSIUM(UNII: 0BZ5A00FQU)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color blue (blue opaque), white (white opaque) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code MYLAN;ZE;80
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-354-1660 in 1 CARTON 30/09/2014
1NDC:51079-354-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202395 09/30/2014 02/28/2018

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 20 mg

NDC 51079-351-16

Ziprasidone HCl
Capsules
20 mg*

60 Capsules (10 x 6)

*Each capsule contains ziprasidone
hydrochloride monohydrate, USP
equivalent to 20 mg of ziprasidone.

Usual Dosage: See accompanying
prescribing information and Patient
Information Leaflet.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Code No.: MH/DRUGS/25/NKD/89

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Rx only

S-11297

Code No.: MH/DRUGS/25/NKD/89

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Ziprasidone HCl 20 mg Capsules Unit Carton LabelZiprasidone HCl 20 mg Capsules Unit Carton Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 40 mg

NDC 51079-352-16

Ziprasidone HCl
Capsules
40 mg*

60 Capsules (10 x 6)

*Each capsule contains ziprasidone
hydrochloride monohydrate, USP
equivalent to 40 mg of ziprasidone.

Usual Dosage: See accompanying
prescribing information and Patient
Information Leaflet.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Code No.: MH/DRUGS/25/NKD/89

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Rx only

S-11298

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Ziprasidone HCl 40 mg Capsules Unit Carton LabelZiprasidone HCl 40 mg Capsules Unit Carton Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 60 mg

NDC 51079-353-16

Ziprasidone HCl
Capsules
60 mg*

60 Capsules (10 x 6)

*Each capsule contains ziprasidone
hydrochloride monohydrate, USP
equivalent to 60 mg of ziprasidone.

Usual Dosage: See accompanying
prescribing information and Patient
Information Leaflet.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Code No.: MH/DRUGS/25/NKD/89

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Rx only

S-11299

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Ziprasidone HCl 60 Capsules Unit Carton LabelZiprasidone HCl 60 Capsules Unit Carton Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 80 mg

NDC 51079-354-16

Ziprasidone HCl
Capsules
80 mg*

60 Capsules (10 x 6)

*Each capsule contains ziprasidone
hydrochloride monohydrate, USP
equivalent to 80 mg of ziprasidone.

Usual Dosage: See accompanying
prescribing information and Patient
Information Leaflet.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Code No.: MH/DRUGS/25/NKD/89

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Rx only

S-11300

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Ziprasidone HCl 80 mg Capsules Unit Carton LabelZiprasidone HCl 80 mg Capsules Unit Carton Label