FDA.reportPublic FDA data

NDC 16729-348-46 - 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
16729-348
Requested NDC
16729-348-46
Package NDCs from labels
16729-348-10, 16729-348-15, 16729-348-16, 16729-348-17, 16729-348-45, 16729-348-46
Manufacturer
Accord Healthcare, Inc. | Intas Pharmaceuticals Ltd
Effective date
2025-10-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
lurasidone hydrochloride - Accord Healthcare, Inc. | Intas Pharmaceuticals LtdAccord Healthcare, Inc. | Intas Pharmaceuticals Ltd2025-10-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-348-10lurasidone hydrochloride30 in 1 BOTTLETABLET, FILM COATED307
16729-348-15lurasidone hydrochloride90 in 1 BOTTLETABLET, FILM COATED907
16729-348-16lurasidone hydrochloride500 in 1 BOTTLETABLET, FILM COATED5007
16729-348-17lurasidone hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10007
16729-348-45lurasidone hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED107
16729-348-46lurasidone hydrochloride10 in 1 CARTONTABLET, FILM COATED107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-348LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]6Current NDC, 6 package rows20241006_7e11ec22-63c1-41a6-899c-4fe746f76bd0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-348-10EA - Each16729-3483767ceba-d6a9-40b8-916b-81c563c1c4ec12023-03-13

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 89 of 104 · 2,064 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coola Bare Republic Mineral Face-Lotion SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%COOLA LLCa334a61d-5c5a-4f45-b202-6dd7bb3d250b2023-12-20WarningsExact identifier
unii: 15FIX9V2JP
Bare Republic Big Adventure Stick SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 16.9%COOLAe800f72f-8c8b-4a12-843f-1ee404055cf02023-12-20WarningsExact identifier
unii: 15FIX9V2JP
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen lightTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.b49d5dc5-8d9b-49e4-8d07-d0d6af3fbbdc2023-12-20WarningsExact identifier
unii: 15FIX9V2JP
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 13N fair neutralTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.f5d54e9d-4963-419a-a091-bdbd1decd2b82023-12-19WarningsExact identifier
unii: 15FIX9V2JP
Valentino Very Valentino Light Lasting Perfecting Foundation Broad Spectrum SPF 26 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE9598949a-0dd6-4932-9dc8-354f9e10b6012023-12-18WarningsExact identifier
unii: 15FIX9V2JP
BB blur tinted moisturizer Broad Spectrum SPF 30 lightTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.207aaa0c-777f-4abd-96b7-64666eb87f532023-12-18WarningsExact identifier
unii: 15FIX9V2JP
Valentino Very Valentino Light Lasting Perfecting Foundation Broad Spectrum SPF 26 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc69e0d803-be76-4cc3-bdeb-b50401d5d6d42023-12-18WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 DeepTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Production8bdd63f7-2f67-4280-9484-d6c8e80ad9b92023-12-16WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium DeepTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8ab49def-c9cd-489e-a936-467067a889402023-12-16WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium DeepTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Production0cb8f22d-2343-415e-9f16-1791567864a12023-12-16WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 DeepTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc83725be5-4a0a-4717-a034-ff2999dd40992023-12-16WarningsExact identifier
unii: 15FIX9V2JP
ERBORIAN - BB CREME NUDE SPF20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L337a771e-c965-421a-a8e7-d853ffe51c2c2023-12-15WarningsExact identifier
unii: 15FIX9V2JP
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
unii: 3NXW29V3WO
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 MediumTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Productionb4cef09a-f0e4-4054-a200-667df7d150bf2023-12-15WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 MediumTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc1f3b56d5-c33a-401f-8c8a-924345a4846e2023-12-15WarningsExact identifier
unii: 15FIX9V2JP
Rejuvity moisturizing day cream BROAD SPECTRUM SPF 15 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEIsagenix International, LLC6d2d5590-5f53-48d9-94c5-fe9f6a5cf3ce2023-12-14WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Fair 01TITANIUM DIOXIDEOrveon Global US LLC29738578-6681-476e-8660-7219f58e8fa02023-12-13WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Production4e56f3f2-b856-4bbc-ab39-6fb5887a48462023-12-13WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc2ce83dc2-84b6-43fd-8b11-495d41cebc222023-12-13WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDECosmetique Active Production4d5d1e79-7b3e-41b5-ae6b-a3b0265702ca2023-12-13WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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