NDC Code(s) : 67877-638-30, 67877-638-90, 67877-638-05, 67877-638-33, 67877-638-38, 67877-639-30, 67877-639-90, 67877-639-05, 67877-639-33, 67877-639-38, 67877-640-30, 67877-640-90, 67877-640-05, 67877-640-33, 67877-640-38, 67877-641-30, 67877-641-90, 67877-641-05, 67877-641-33, 67877-641-38, 67877-642-30, 67877-642-90, 67877-642-05, 67877-642-33, 67877-642-38
Packager : Ascend Laboratories, LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

lurasidone hydrochloride lurasidone hydrochloride TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-638
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LURASIDONE HYDROCHLORIDE(UNII: O0P4I5851I)
(LURASIDONE - UNII:22IC88528T) 		LURASIDONE HYDROCHLORIDE20 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
POVIDONE K30(UNII: U725QWY32X)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
Product Characteristics
Color WHITE (off-white) Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code L;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-638-3030 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
2NDC:67877-638-9090 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
3NDC:67877-638-05500 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
4NDC:67877-638-3810 in 1 CARTON 01/04/2023
4NDC:67877-638-3310 in 1 BLISTER PACK Type 0: Not a Combination Product01/04/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212244 01/04/2023
lurasidone hydrochloride lurasidone hydrochloride TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-639
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LURASIDONE HYDROCHLORIDE(UNII: O0P4I5851I)
(LURASIDONE - UNII:22IC88528T) 		LURASIDONE HYDROCHLORIDE40 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
POVIDONE K30(UNII: U725QWY32X)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
Product Characteristics
Color WHITE (off-white) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code L;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-639-3030 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
2NDC:67877-639-9090 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
3NDC:67877-639-05500 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
4NDC:67877-639-3810 in 1 CARTON 01/04/2023
4NDC:67877-639-3310 in 1 BLISTER PACK Type 0: Not a Combination Product01/04/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212244 01/04/2023
lurasidone hydrochloride lurasidone hydrochloride TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-640
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LURASIDONE HYDROCHLORIDE(UNII: O0P4I5851I)
(LURASIDONE - UNII:22IC88528T) 		LURASIDONE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
POVIDONE K30(UNII: U725QWY32X)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
Product Characteristics
Color WHITE (off-white) Score no score
Shape CAPSULE Size 13 mm
Flavor Imprint Code L;60
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-640-3030 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
2NDC:67877-640-9090 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
3NDC:67877-640-05500 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
4NDC:67877-640-3810 in 1 CARTON 01/04/2023
4NDC:67877-640-3310 in 1 BLISTER PACK Type 0: Not a Combination Product01/04/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212244 01/04/2023
lurasidone hydrochloride lurasidone hydrochloride TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-641
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LURASIDONE HYDROCHLORIDE(UNII: O0P4I5851I)
(LURASIDONE - UNII:22IC88528T) 		LURASIDONE HYDROCHLORIDE80 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
POVIDONE K30(UNII: U725QWY32X)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color GREEN (Light-green) Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code L;80
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-641-3030 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
2NDC:67877-641-9090 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
3NDC:67877-641-05500 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
4NDC:67877-641-3810 in 1 CARTON 01/04/2023
4NDC:67877-641-3310 in 1 BLISTER PACK Type 0: Not a Combination Product01/04/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212244 01/04/2023
lurasidone hydrochloride lurasidone hydrochloride TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-642
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LURASIDONE HYDROCHLORIDE(UNII: O0P4I5851I)
(LURASIDONE - UNII:22IC88528T) 		LURASIDONE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL(UNII: 3OWL53L36A)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
POVIDONE K30(UNII: U725QWY32X)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
Product Characteristics
Color WHITE (off-white) Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code L;120
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-642-3030 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
2NDC:67877-642-9090 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
3NDC:67877-642-05500 in 1 BOTTLE Type 0: Not a Combination Product01/04/2023
4NDC:67877-642-3810 in 1 CARTON 01/04/2023
4NDC:67877-642-3310 in 1 BLISTER PACK Type 0: Not a Combination Product01/04/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212244 01/04/2023

LABELER - Ascend Laboratories, LLC(141250469)

Establishment
Name Address ID/FEI Business Operations
Alkem Laboratories Limited 677605851 ANALYSIS(67877-638, 67877-639, 67877-640, 67877-641, 67877-642), MANUFACTURE(67877-638, 67877-639, 67877-640, 67877-641, 67877-642), PACK(67877-638, 67877-639, 67877-640, 67877-641, 67877-642)

PRINCIPAL DISPLAY PANEL

NDC: 67877-638-30
Lurasidone Hydrochloride Tablets 20 mg
30 Tablets

lurasidone-20mg-30tab-1

NDC: 67877-639-90

Lurasidone Hydrochloride Tablets 40 mg
90 Tablets

lurasidone-20mg-30tab-1

NDC: 67877-640-30
Lurasidone Hydrochloride Tablets 60 mg
30 Tablets
 lurasidone-20mg-30tab-1

NDC: 67877-641-38
Lurasidone Hydrochloride Tablets 80 mg
Carton of 100 (10X10) Unit dose Tablets

lurasidone-20mg-30tab-1

NDC: 67877-642-05
Lurasidone Hydrochloride Tablets 120 mg
500 Tablets

lurasidone-20mg-30tab-1