LURASIDONE HYDROCHLORIDE tablet, coated

Lurasidone hydrochloride by

Drug Labeling and Warnings

Lurasidone hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1734-3

Lurasidone hydrochloride tablets, 20 mg

30 tablets

Rx only

NDC: 70771-1735-9

Lurasidone hydrochloride tablets, 40 mg

90 tablets

Rx only

NDC: 70771-1736-3

Lurasidone hydrochloride tablets, 60 mg

30 tablets

Rx only

NDC: 70771-1737-3

Lurasidone hydrochloride tablets, 80 mg

30 tablets

Rx only

NDC: 70771-1738-3

Lurasidone hydrochloride tablets, 120 mg

30 tablets

Rx only

INGREDIENTS AND APPEARANCE

LURASIDONE HYDROCHLORIDE 
lurasidone hydrochloride tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1734
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T)	LURASIDONE HYDROCHLORIDE	20 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW (YELLOW TO LIGHT YELLOW)	Score	no score
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	C31
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1734-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
2	NDC: 70771-1734-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
3	NDC: 70771-1734-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
4	NDC: 70771-1734-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
5	NDC: 70771-1734-4	10 in 1 CARTON	02/01/2023
5	NDC: 70771-1734-2	10 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	ANDA208052	02/01/2023

LURASIDONE HYDROCHLORIDE 
lurasidone hydrochloride tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1735
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T)	LURASIDONE HYDROCHLORIDE	40 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	8mm
Flavor		Imprint Code	C32
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1735-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
2	NDC: 70771-1735-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
3	NDC: 70771-1735-4	10 in 1 CARTON	02/01/2023
3	NDC: 70771-1735-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 70771-1735-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
5	NDC: 70771-1735-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208052	02/01/2023

LURASIDONE HYDROCHLORIDE 
lurasidone hydrochloride tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1736
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T)	LURASIDONE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE TO OFF WHITE)	Score	no score
Shape	CAPSULE (MODIFIED CAPSULE)	Size	13mm
Flavor		Imprint Code	C33
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1736-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
2	NDC: 70771-1736-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
3	NDC: 70771-1736-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
4	NDC: 70771-1736-4	10 in 1 CARTON	02/01/2023
4	NDC: 70771-1736-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 70771-1736-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208052	02/01/2023

LURASIDONE HYDROCHLORIDE 
lurasidone hydrochloride tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1737
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T)	LURASIDONE HYDROCHLORIDE	80 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW (YELLOW TO LIGHT YELLOW)	Score	no score
Shape	OVAL (OVAL)	Size	12mm
Flavor		Imprint Code	C34
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1737-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
2	NDC: 70771-1737-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
3	NDC: 70771-1737-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
4	NDC: 70771-1737-4	10 in 1 CARTON	02/01/2023
4	NDC: 70771-1737-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 70771-1737-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208052	02/01/2023

LURASIDONE HYDROCHLORIDE 
lurasidone hydrochloride tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1738
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T)	LURASIDONE HYDROCHLORIDE	120 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
POLOXAMER 407 (UNII: TUF2IVW3M2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	WHITE (WHITE TO OFF WHITE)	Score	no score
Shape	OVAL (OVAL)	Size	15mm
Flavor		Imprint Code	C35
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1738-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
2	NDC: 70771-1738-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
3	NDC: 70771-1738-4	10 in 1 CARTON	02/01/2023
3	NDC: 70771-1738-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 70771-1738-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023
5	NDC: 70771-1738-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208052	02/01/2023

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1734, 70771-1735, 70771-1736, 70771-1737, 70771-1738) , MANUFACTURE(70771-1734, 70771-1735, 70771-1736, 70771-1737, 70771-1738)