FDA.reportPublic FDA data

NDC 68382-965-30 - Lurasidone hydrochloride

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
68382-965
Requested NDC
68382-965-30
Package NDCs from labels
68382-965-06, 68382-965-16, 68382-965-01, 68382-965-05, 68382-965-30, 68382-965-77
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
Effective date
2026-07-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LURASIDONE - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2026-07-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-965-01Lurasidone hydrochloride100 in 1 BOTTLETABLET, COATED1007
68382-965-05Lurasidone hydrochloride500 in 1 BOTTLETABLET, COATED5007
68382-965-06Lurasidone hydrochloride30 in 1 BOTTLETABLET, COATED307
68382-965-16Lurasidone hydrochloride90 in 1 BOTTLETABLET, COATED907
68382-965-30Lurasidone hydrochloride1 in 1 BLISTER PACKTABLET, COATED17
68382-965-77Lurasidone hydrochloride100 in 1 CARTONTABLET, COATED1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-965LURASIDONE HYDROCHLORIDE TABLET, COATED [ZYDUS PHARMACEUTICALS USA INC.]7Current NDC, 6 package rows20250323_bceb350e-4b88-4de1-9629-9629365a27a7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-965-06EA - Each68382-9657452d20d-6820-4a5c-a404-22219213ed0012023-03-13

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 109 · 2,167 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
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
application number: ANDA208052
ndc (package): 68382-859-01
ndc (package): 68382-965-05
ndc (package): 68382-968-30
ndc (package): 68382-859-30
ndc (package): 68382-967-06
ndc (package): 68382-965-06
ndc (package): 68382-966-30
ndc (package): 68382-966-06
ndc (package): 68382-965-16
ndc (package): 68382-967-05
ndc (package): 68382-859-06
ndc (package): 68382-968-16
ndc (package): 68382-966-05
ndc (package): 68382-968-05
ndc (package): 68382-967-77
ndc (package): 68382-966-77
ndc (package): 68382-965-77
ndc (package): 68382-967-01
ndc (package): 68382-968-06
ndc (package): 68382-966-16
ndc (package): 68382-965-01
ndc (package): 68382-967-16
ndc (package): 68382-968-77
ndc (package): 68382-859-16
ndc (package): 68382-968-01
ndc (package): 68382-967-30
ndc (package): 68382-966-01
ndc (package): 68382-859-05
ndc (package): 68382-965-30
ndc (package): 68382-859-77
ndc (product): 68382-967
ndc (product): 68382-966
ndc (product): 68382-965
ndc (product): 68382-859
ndc (product): 68382-968
ndc11 (package): 68382096530
rxcui: 1040041
rxcui: 1040031
rxcui: 1297278
rxcui: 1431235
rxcui: 1235247
spl id: 5e755270-5e9a-4208-b52b-3eaeaf652902
spl set id: bceb350e-4b88-4de1-9629-9629365a27a7
unii: O0P4I5851I
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: 532B59J990
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
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
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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