FDA.reportPublic FDA data

NDC 70518-3010-1 - 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
70518-3010
Requested NDC
70518-3010-1
Package NDCs from labels
70518-3010-1, 70518-3010-0
Manufacturer
REMEDYREPACK INC.
Effective date
2021-02-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Latuda - REMEDYREPACK INC.REMEDYREPACK INC.2021-02-03HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3010-02025-09-08C16284748780-1f386c649-d75c-0266-e053-dadaa90a7c1aThese 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
70518-3010-02023-01-30C16284748780-1f386c649-d75c-0266-e053-dadaa90a7c1aThese 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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3010LATUDA (LURASIDONE HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC.]1Legacy NDC20210204_2a26c9b9-4436-48b2-9c5d-d0af4500ad57.zip

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 1 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.a97b59db-29e8-4b00-9d35-56b47335ee252026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1235247
unii: O0P4I5851I
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.6008ccac-948e-4b6a-a288-7dd245c2bac42026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1235247
unii: O0P4I5851I
Lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.672d22f6-fad5-49db-9206-f924d02af1812026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040031
unii: O0P4I5851I
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEGolden State Medical Supply, Inc.1989d512-e568-468f-e063-6294a90a5c222026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1297278
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
Lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.bceb350e-4b88-4de1-9629-9629365a27a72026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1297278
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.083a1a52-5a13-4e28-8ef2-127ac4ce5b2d2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1297278
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDEAurobindo Pharma Limitedb3e9cc86-0c5c-444f-ab57-f4d1a68650352026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1297278
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDESun Pharmaceutical Industries, Inc.6d97d871-66d3-4ed8-bbc5-0620e9f69ae52026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1297278
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEMacleods Pharmaceuticals Limited2b07a830-93ba-427a-95fc-5138a6309f1e2026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1297278
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDETorrent Pharmaceuticals Limited9cb5e275-1029-407a-8c93-ec5cde2d323b2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1297278
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDECoupler LLC4aa17493-69eb-9dc7-e063-6294a90a4c0b2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1431235
unii: O0P4I5851I
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEREMEDYREPACK INC.0115b2fa-4c11-4f91-abe7-8293903e066c2026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1235247
unii: O0P4I5851I
LURASIDONE HYDROCHLORIDELURASIDONE HYDROCHLORIDECoupler LLC4973beed-b75b-c370-e063-6394a90a26e52026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1431235
unii: O0P4I5851I
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDECoupler LLC4742c2fd-303b-da08-e063-6294a90a76212025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040031
unii: O0P4I5851I
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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