ZIPRASIDONE- ziprasidone capsule
Zydus Lifesciences Limited

----------

ZIPRASIDONE HYDROCHLORIDE CAPSULES

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1179-6

Ziprasidone capsules, 20 mg

60 Capsules

Rx only

NDC 70771-1180-6

Ziprasidone capsules, 40 mg

60 Capsules

Rx only

NDC 70771-1181-6

Ziprasidone capsules, 60 mg

60 Capsules

Rx only

NDC 70771-1182-6

Ziprasidone capsules, 80 mg

60 Capsules

Rx only

ZIPRASIDONE
ziprasidone capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1179
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X)	ZIPRASIDONE	20 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1179-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2017	03/25/2025
2	NDC:70771-1179-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2017	03/25/2025
3	NDC:70771-1179-8	8 in 1 CARTON	12/28/2017	03/25/2025
3	NDC:70771-1179-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208988	12/28/2017	08/14/2025

ZIPRASIDONE
ziprasidone capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1180
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X)	ZIPRASIDONE	80 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1180-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2017	03/25/2025
2	NDC:70771-1180-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2017	03/25/2025
3	NDC:70771-1180-8	8 in 1 CARTON	12/28/2017	03/25/2025
3	NDC:70771-1180-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208988	12/28/2017	08/14/2025

ZIPRASIDONE
ziprasidone capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1181
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X)	ZIPRASIDONE	60 mg

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE OPAQUE CAP) , WHITE (WHITE OPAQUE BODY)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	18mm
Flavor		Imprint Code	239
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1181-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2017	03/25/2025
2	NDC:70771-1181-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2017	03/25/2025
3	NDC:70771-1181-8	8 in 1 CARTON	12/28/2017	03/25/2025
3	NDC:70771-1181-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208988	12/28/2017	08/14/2025

ZIPRASIDONE
ziprasidone capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1182
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X)	ZIPRASIDONE	40 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1182-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2017	03/25/2025
2	NDC:70771-1182-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2017	03/25/2025
3	NDC:70771-1182-8	8 in 1 CARTON	12/28/2017	03/25/2025
3	NDC:70771-1182-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208988	12/28/2017	08/14/2025

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1179, 70771-1180, 70771-1181, 70771-1182) , MANUFACTURE(70771-1179, 70771-1180, 70771-1181, 70771-1182)

Revised: 8/2025

Document Id: 5acc0d98-6049-414e-9eb9-d545d54648a7

Set id: d607e3c2-62f5-4f4c-bbb3-423ac9478420

Version: 6

Effective Time: 20250814

Zydus Lifesciences Limited