NDC 63402-302-01 - Latuda

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 63402-302
Requested NDC: 63402-302-01
Package NDCs from labels: 63402-302-30, 63402-302-90, 63402-302-50, 63402-302-01, 63402-302-10, 63402-302-07, 63402-302-04
Manufacturer: Sumitomo Pharma America, Inc.
Effective date: 2025-01-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Latuda - Sumitomo Pharma America, Inc.	Sumitomo Pharma America, Inc.	2025-01-31	HUMAN PRESCRIPTION DRUG LABEL
Latuda - REMEDYREPACK INC.	REMEDYREPACK INC.	2019-03-13	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63402-302-01	Latuda	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	37
63402-302-04	Latuda	4 in 1 CARTON	TABLET, FILM COATED	4	37
63402-302-07	Latuda	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	37
63402-302-10	Latuda	10 in 1 CARTON	TABLET, FILM COATED	10	37
63402-302-30	Latuda	30 in 1 BOTTLE	TABLET, FILM COATED	30	37
63402-302-50	Latuda	500 in 1 BOTTLE	TABLET, FILM COATED	500	37
63402-302-90	Latuda	90 in 1 BOTTLE	TABLET, FILM COATED	90	37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63402-302	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC.]	36	Current NDC, Legacy NDC, 7 package rows	20250206_afad3051-9df2-4c54-9684-e8262a133af8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63402-302-30	EA - Each	63402-302	a308d3b4-f334-4634-bc3c-5e6bf6e51eb2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lurasidone hydrochloride	ACTIVE INGREDIENT	O0P4I5851I	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
lurasidone	ACTIVE MOIETY	22IC88528T	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
Carnauba Wax	INACTIVE INGREDIENT	R12CBM0EIZ	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
FD&C blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
hypromellose 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
mannitol	INACTIVE INGREDIENT	3OWL53L36A	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]	15

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QR PAIN	ANALGESIC	MARYHELENE ENTERPRISES INC	9984a510-30be-4013-e053-2995a90a841e	2025-11-14	Warnings	Exact identifier unii: 3OWL53L36A
Mannitol	MANNITOL	ProPharma Distribution	430669d7-9ad1-9a04-e063-6394a90ababb	2025-11-07	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
Sorbitol-Mannitol	SORBITOL AND MANNITOL	ICU Medical Inc.	5b44e248-4b7b-4777-954a-921c7b309944	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
Mannitol	MANNITOL	ICU Medical Inc.	ba7bf864-8a4d-4262-8fd1-00174fa2f9d1	2025-10-24	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Accord Healthcare, Inc.	7e11ec22-63c1-41a6-899c-4fe746f76bd0	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1040041 rxcui: 1040031 rxcui: 1297278 rxcui: 1431235 rxcui: 1235247 unii: O0P4I5851I
Lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Torrent Pharmaceuticals Limited	a101e62e-dd1f-4add-8393-ba6d54adce06	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1431235 unii: O0P4I5851I
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	74f2429b-71df-47f0-9cb5-98685372a9b8	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1040041 rxcui: 1040031 rxcui: 1297278 rxcui: 1431235 rxcui: 1235247 unii: O0P4I5851I
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Major Pharmaceuticals	d8b9ba36-fb02-4f52-b0ed-7fdd81d50c4c	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1040041 rxcui: 1040031 rxcui: 1297278 rxcui: 1431235 rxcui: 1235247 unii: O0P4I5851I
Osmitrol	MANNITOL	Baxter Healthcare Company	0d914965-7001-45cb-ba51-d7c5964b05bc	2025-08-26	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	4f969224-a9f0-4089-84d6-a15664ea7bfe	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1040041 rxcui: 1040031 rxcui: 1297278 rxcui: 1431235 rxcui: 1235247 unii: O0P4I5851I
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	c80625bb-7857-4763-81fe-542b3448d84f	2025-07-19	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1040041 rxcui: 1040031 rxcui: 1297278 rxcui: 1431235 rxcui: 1235247 unii: O0P4I5851I
Mannitol	MANNITOL	Henry Schein, Inc.	e2444db1-9dfe-451f-a33c-9b00786464d2	2025-05-20	Warnings, Adverse reactions	Exact identifier unii: 3OWL53L36A
LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	Proficient Rx LP	fa9f0d28-c525-4a1e-acec-84c82e10b9a2	2025-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1235247 unii: O0P4I5851I
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Cipla USA, Inc.	76c055aa-d96a-42e5-a670-1db63b9c1dd6	2025-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1040041 rxcui: 1040031 rxcui: 1297278 rxcui: 1431235 rxcui: 1235247 unii: O0P4I5851I
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Exelan Pharmaceuticals Inc.	4223e7f8-acbb-4738-9b77-ddc3405afb25	2025-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1040041 rxcui: 1040031 rxcui: 1297278 rxcui: 1431235 rxcui: 1235247 unii: O0P4I5851I
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	1cc441b3-0a23-4c68-a90e-436030b7daf2	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1040041 rxcui: 1040031 rxcui: 1297278 rxcui: 1431235 rxcui: 1235247 unii: O0P4I5851I
Lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	Dr. Reddys Laboratories Inc	9b512af1-98ab-1242-10e8-9534a002306e	2025-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1040041 rxcui: 1040031 rxcui: 1431235 rxcui: 1235247 unii: O0P4I5851I
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Amneal Pharmaceuticals LLC	6ef0b2f9-9356-4f61-a2fa-e7c2c77a5d3a	2025-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1040041 rxcui: 1040031 rxcui: 1297278 rxcui: 1431235 rxcui: 1235247 unii: O0P4I5851I
Latuda	LURASIDONE HYDROCHLORIDE	Sumitomo Pharma America, Inc.	afad3051-9df2-4c54-9684-e8262a133af8	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: NDA200603 ndc (package): 63402-304-01 ndc (package): 63402-304-50 ndc (package): 63402-302-10 ndc (package): 63402-302-30 ndc (package): 63402-302-90 ndc (package): 63402-306-07 ndc (package): 63402-308-07 ndc (package): 63402-312-90 ndc (package): 63402-304-30 ndc (package): 63402-302-07 ndc (package): 63402-312-04 ndc (package): 63402-308-30 ndc (package): 63402-304-10 ndc (package): 63402-302-01 ndc (package): 63402-312-30 ndc (package): 63402-308-04 ndc (package): 63402-304-04 ndc (package): 63402-306-30 ndc (package): 63402-306-50 ndc (package): 63402-306-01 ndc (package): 63402-308-10 ndc (package): 63402-312-01 ndc (package): 63402-312-10 ndc (package): 63402-308-90 ndc (package): 63402-304-07 ndc (package): 63402-306-04 ndc (package): 63402-312-07 ndc (package): 63402-312-50 ndc (package): 63402-308-01 ndc (package): 63402-304-90 ndc (package): 63402-306-90 ndc (package): 63402-306-10 ndc (package): 63402-308-50 ndc (package): 63402-302-50 ndc (package): 63402-302-04 ndc (product): 63402-306 ndc (product): 63402-302 ndc (product): 63402-304 ndc (product): 63402-312 ndc (product): 63402-308 ndc11 (package): 63402030201 rxcui: 1235249 rxcui: 1040041 rxcui: 1040043 rxcui: 1431237 rxcui: 1297357 rxcui: 1040031 rxcui: 1040036 rxcui: 1297278 rxcui: 1431235 rxcui: 1235247 spl id: 7383b0e0-01e8-4778-96f0-6f2e0c9586ae spl set id: afad3051-9df2-4c54-9684-e8262a133af8 unii: O0P4I5851I
lurasidone hydrochloride	LURASIDONE HYDROCHLORIDE	NorthStar RxLLC	10a88607-0b5e-4707-b0cb-40c58a5c6774	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1040041 rxcui: 1040031 rxcui: 1431235 rxcui: 1235247 unii: O0P4I5851I

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.