FDA.reportPublic FDA data

NDC 43598-352-79 - 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
43598-352
Requested NDC
43598-352-79
Package NDCs from labels
43598-352-30, 43598-352-90, 43598-352-05, 43598-352-79, 43598-352-78
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lurasidone hydrochloride - REMEDYREPACK INC.REMEDYREPACK INC.2026-08-27HUMAN PRESCRIPTION DRUG LABEL
Lurasidone hydrochloride - Dr. Reddys Laboratories Inc | Dr. Reddys Laboratories Limited (SEZ UNIT)Dr. Reddys Laboratories Inc | Dr. Reddys Laboratories Limited (SEZ UNIT)2025-02-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-352-05Lurasidone hydrochloride500 in 1 BOTTLETABLET, FILM COATED50013
43598-352-30Lurasidone hydrochloride30 in 1 BOTTLETABLET, FILM COATED3013
43598-352-78Lurasidone hydrochloride10 in 1 CARTONTABLET, FILM COATED1013
43598-352-79Lurasidone hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED1013
43598-352-90Lurasidone hydrochloride90 in 1 BOTTLETABLET, FILM COATED9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-352LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES INC]13Current NDC, 5 package rows20250402_9b512af1-98ab-1242-10e8-9534a002306e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-352-30EA - Each43598-3521602aaf8-4a22-4cf0-b250-481b2fc53da012023-03-13

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 63 of 102 · 2,037 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38TITANIUM DIOXIDEEai-jr 286, Inc303d5d5a-4c7a-1e23-e063-6294a90a0e582025-03-13WarningsExact identifier
unii: 15FIX9V2JP
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: 15FIX9V2JP
MINERAL TINTED SPF 30TITANIUM DIOXIDE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f9e2252-fb54-363f-e063-6294a90aa7c92025-03-04WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Kids Mineral Sun StickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2f7225d0-ddfa-e19a-e063-6294a90a52a82025-03-03WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21c9f9-acf8-997b-e063-6394a90ada3f2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e232e8d-4274-68bc-e063-6394a90a942b2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDECipla USA, Inc.76c055aa-d96a-42e5-a670-1db63b9c1dd62025-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEExelan Pharmaceuticals Inc.4223e7f8-acbb-4738-9b77-ddc3405afb252025-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEAlembic Pharmaceuticals Inc.1cc441b3-0a23-4c68-a90e-436030b7daf22025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
HA Physical Tint SPF 44ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea5e19d77-703e-41e0-9a02-19227dc6c8192025-02-27WarningsExact identifier
unii: 15FIX9V2JP
BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILLZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC2f069114-9ca8-aed4-e063-6394a90a46d82025-02-26WarningsExact identifier
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream230 NMelaleuca Inc.2f133abb-cad2-2ac8-e063-6294a90aa4802025-02-26WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2efb73a6-601d-61a4-e063-6294a90af8252025-02-25WarningsExact identifier
unii: 15FIX9V2JP
Lurasidone hydrochlorideLURASIDONE HYDROCHLORIDEDr. Reddys Laboratories Inc9b512af1-98ab-1242-10e8-9534a002306e2025-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208047
ndc (package): 43598-354-90
ndc (package): 43598-351-05
ndc (package): 43598-353-79
ndc (package): 43598-354-78
ndc (package): 43598-351-30
ndc (package): 43598-351-79
ndc (package): 43598-353-78
ndc (package): 43598-354-79
ndc (package): 43598-354-30
ndc (package): 43598-351-90
ndc (package): 43598-353-05
ndc (package): 43598-352-90
ndc (package): 43598-352-78
ndc (package): 43598-352-79
ndc (package): 43598-353-90
ndc (package): 43598-352-30
ndc (package): 43598-354-05
ndc (package): 43598-353-30
ndc (package): 43598-352-05
ndc (package): 43598-351-78
ndc (product): 43598-352
ndc (product): 43598-351
ndc (product): 43598-353
ndc (product): 43598-354
ndc11 (package): 43598035279
rxcui: 1040041
rxcui: 1040031
rxcui: 1431235
rxcui: 1235247
spl id: f3c17d88-383d-89de-d8d6-8ed1bb1b3750
spl set id: 9b512af1-98ab-1242-10e8-9534a002306e
unii: O0P4I5851I
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2ee82379-6609-fd8e-e063-6294a90acf6c2025-02-24WarningsExact identifier
unii: 15FIX9V2JP
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oilyOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10edc0c1-9359-4c7a-a56e-bad06fea00562025-02-20WarningsExact identifier
unii: 15FIX9V2JP
Lurasidone HydrochlorideLURASIDONE HYDROCHLORIDEAmneal Pharmaceuticals LLC6ef0b2f9-9356-4f61-a2fa-e7c2c77a5d3a2025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1040041
rxcui: 1040031
rxcui: 1431235
rxcui: 1235247
unii: O0P4I5851I
Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20cd4d96-2046-3a50-e063-6394a90a12192025-02-18WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2082aa-5ae3-2c04-e063-6294a90a140b2025-02-14WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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