LURASIDONE HYDROCHLORIDE- lurasidone hydrochloride tablet, coated 
Zydus Lifesciences Limited

----------

Lurasidone Hydrochloride Tablets

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1734-3

Lurasidone hydrochloride tablets, 20 mg

30 tablets

Rx only

20 mg

NDC 70771-1735-9

Lurasidone hydrochloride tablets, 40 mg

90 tablets

Rx only

40 mg

NDC 70771-1736-3

Lurasidone hydrochloride tablets, 60 mg

30 tablets

Rx only

60 mg

NDC 70771-1737-3

Lurasidone hydrochloride tablets, 80 mg

30 tablets

Rx only

80 mg

NDC 70771-1738-3

Lurasidone hydrochloride tablets, 120 mg

30 tablets

Rx only

120 mg
LURASIDONE HYDROCHLORIDE 
lurasidone hydrochloride tablet, coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1734
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T) LURASIDONE HYDROCHLORIDE20 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (YELLOW TO LIGHT YELLOW) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code C31
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1734-330 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
2NDC:70771-1734-990 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
3NDC:70771-1734-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
4NDC:70771-1734-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
5NDC:70771-1734-410 in 1 CARTON02/01/2023
5NDC:70771-1734-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20805202/01/2023
LURASIDONE HYDROCHLORIDE 
lurasidone hydrochloride tablet, coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1735
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T) LURASIDONE HYDROCHLORIDE40 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE TO OFF WHITE) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code C32
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1735-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
2NDC:70771-1735-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
3NDC:70771-1735-410 in 1 CARTON02/01/2023
3NDC:70771-1735-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:70771-1735-990 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
5NDC:70771-1735-330 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20805202/01/2023
LURASIDONE HYDROCHLORIDE 
lurasidone hydrochloride tablet, coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1736
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T) LURASIDONE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE TO OFF WHITE) Scoreno score
ShapeCAPSULE (MODIFIED CAPSULE) Size13mm
FlavorImprint Code C33
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1736-990 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
2NDC:70771-1736-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
3NDC:70771-1736-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
4NDC:70771-1736-410 in 1 CARTON02/01/2023
4NDC:70771-1736-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:70771-1736-330 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20805202/01/2023
LURASIDONE HYDROCHLORIDE 
lurasidone hydrochloride tablet, coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1737
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T) LURASIDONE HYDROCHLORIDE80 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (YELLOW TO LIGHT YELLOW) Scoreno score
ShapeOVAL (OVAL) Size12mm
FlavorImprint Code C34
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1737-990 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
2NDC:70771-1737-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
3NDC:70771-1737-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
4NDC:70771-1737-410 in 1 CARTON02/01/2023
4NDC:70771-1737-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:70771-1737-330 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20805202/01/2023
LURASIDONE HYDROCHLORIDE 
lurasidone hydrochloride tablet, coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1738
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T) LURASIDONE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE TO OFF WHITE) Scoreno score
ShapeOVAL (OVAL) Size15mm
FlavorImprint Code C35
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1738-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
2NDC:70771-1738-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
3NDC:70771-1738-410 in 1 CARTON02/01/2023
3NDC:70771-1738-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:70771-1738-330 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
5NDC:70771-1738-990 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20805202/01/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1734, 70771-1735, 70771-1736, 70771-1737, 70771-1738) , MANUFACTURE(70771-1734, 70771-1735, 70771-1736, 70771-1737, 70771-1738)

Revised: 9/2023
Document Id: 14f4886e-e6d8-4190-8af1-c617ccd306ae
Set id: 0f5f8228-1304-4981-8577-029136627260
Version: 3
Effective Time: 20230927
 
Zydus Lifesciences Limited