Latuda
These highlights do not include all the information needed to use LATUDA safely and effectively. See full prescribing information for LATUDA. LATUDA (lurasidone hydrochloride) tablets, for oral use Initial U.S. Approval: 2010
Approved
Approval ID
afad3051-9df2-4c54-9684-e8262a133af8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2023
Manufacturers
FDA
Sumitomo Pharma America, Inc.
DUNS: 131661746
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lurasidone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63402-308
Application NumberNDA200603
Product Classification
M
Marketing Category
C73594
G
Generic Name
lurasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2023
FDA Product Classification
INGREDIENTS (9)
lurasidone hydrochlorideActive
Quantity: 80 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
hypromellose 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
FD&C blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Carnauba WaxInactive
Code: R12CBM0EIZ
Classification: IACT
lurasidone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63402-304
Application NumberNDA200603
Product Classification
M
Marketing Category
C73594
G
Generic Name
lurasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2023
FDA Product Classification
INGREDIENTS (7)
lurasidone hydrochlorideActive
Quantity: 40 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
hypromellose 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
Carnauba WaxInactive
Code: R12CBM0EIZ
Classification: IACT
lurasidone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63402-302
Application NumberNDA200603
Product Classification
M
Marketing Category
C73594
G
Generic Name
lurasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2023
FDA Product Classification
INGREDIENTS (7)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
hypromellose 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Carnauba WaxInactive
Code: R12CBM0EIZ
Classification: IACT
lurasidone hydrochlorideActive
Quantity: 20 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
lurasidone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63402-306
Application NumberNDA200603
Product Classification
M
Marketing Category
C73594
G
Generic Name
lurasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2023
FDA Product Classification
INGREDIENTS (7)
lurasidone hydrochlorideActive
Quantity: 60 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
hypromellose 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Carnauba WaxInactive
Code: R12CBM0EIZ
Classification: IACT
lurasidone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63402-312
Application NumberNDA200603
Product Classification
M
Marketing Category
C73594
G
Generic Name
lurasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2023
FDA Product Classification
INGREDIENTS (7)
lurasidone hydrochlorideActive
Quantity: 120 mg in 1 1
Code: O0P4I5851I
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
Carnauba WaxInactive
Code: R12CBM0EIZ
Classification: IACT
hypromellose 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT