FDA.reportPublic FDA data

NDC 63402-306-01 - 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
63402-306
Requested NDC
63402-306-01
Package NDCs from labels
63402-306-30, 63402-306-90, 63402-306-50, 63402-306-01, 63402-306-10, 63402-306-07, 63402-306-04
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
LabelManufacturerEffective dateType
Latuda - Sumitomo Pharma America, Inc.Sumitomo Pharma America, Inc.2025-01-31HUMAN PRESCRIPTION DRUG LABEL
Latuda - REMEDYREPACK INC.REMEDYREPACK INC.2021-02-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63402-306-01Latuda10 in 1 BLISTER PACKTABLET, FILM COATED1037
63402-306-04Latuda4 in 1 CARTONTABLET, FILM COATED437
63402-306-07Latuda7 in 1 BLISTER PACKTABLET, FILM COATED737
63402-306-10Latuda10 in 1 CARTONTABLET, FILM COATED1037
63402-306-30Latuda30 in 1 BOTTLETABLET, FILM COATED3037
63402-306-50Latuda500 in 1 BOTTLETABLET, FILM COATED50037
63402-306-90Latuda90 in 1 BOTTLETABLET, FILM COATED9037

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63402-306LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC.]36Current NDC, Legacy NDC, 7 package rows20250206_afad3051-9df2-4c54-9684-e8262a133af8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63402-306-01EA - Each63402-306df5157b6-577f-4d3e-a0df-f9677a2c640c12014-05-02
63402-306-10EA - Each63402-30642ec1665-34c1-4fed-9eef-bc7e2830ee2312014-05-02
63402-306-30EA - Each63402-3067e18930f-00a4-49a0-883c-87fde717156012013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lurasidone hydrochlorideACTIVE INGREDIENTO0P4I5851ILATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]15
lurasidoneACTIVE MOIETY22IC88528TLATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]15
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZLATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]15
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]15
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQKLATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]15
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTLATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]15
hypromellose 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]15
magnesium stearateINACTIVE INGREDIENT70097M6I30LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]15
mannitolINACTIVE INGREDIENT3OWL53L36ALATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [SUNOVION PHARMACEUTICALS INC.]15
starch, cornINACTIVE INGREDIENTO8232NY3SJLATUDA (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 3 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEAmerican Health Packagingb83e1015-8016-4c7c-8239-8dba3a882e462025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
Lurasidone HCLLURASIDONE HCLDirect_rx296811cf-cba8-16c2-e063-6294a90acfa62024-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040031
unii: O0P4I5851I
Lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEZydus Lifesciences Limited0f5f8228-1304-4981-8577-0291366272602024-11-30Exact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1297278
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC84648adf-b3c6-476e-8d11-2a9d7c5eb5502024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1297278
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEA-S Medication Solutionsc96cbfc9-773b-410a-ada3-2822cbd58f8f2024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1235247
unii: O0P4I5851I
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEA-S Medication Solutionsb848e6f3-63c0-4d2e-bda5-c9e9614720922024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1235247
unii: O0P4I5851I
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEMAJOR PHARMACEUTICALScecfd4c8-bff3-44fa-b360-b3e8a8e955f52023-12-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1297278
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEA-S Medication Solutions3cd2da15-4d51-4e5c-b683-1936dc19e2342023-04-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1235247
unii: O0P4I5851I
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
f641d2fb-38a6-f4a2-e053-2a95a90aead13672640c-ecde-4a14-8bcf-b3a7799fcf612023-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 3672640c-ecde-4a14-8bcf-b3a7799fcf61
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEAlembic Pharmaceuticals Limited27f70e15-ee22-47ae-ba87-20e2b4a1a4d62023-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1297278
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEDr. Reddys Laboratories Inc2f22a0bd-94f3-53d7-717c-03da8e1a7e972023-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1297278
unii: O0P4I5851I
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEAscend Laboratories, LLC36b6bacd-ac11-493b-a8a4-8dad448ed9d52023-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1297278
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I

Reported adverse events (FAERS/openFDA)#

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