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 92 of 104 · 2,064 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Sheer Mineral Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.581e8289-1406-45b6-9786-753800665fad2023-11-20WarningsExact identifier
unii: 15FIX9V2JP
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a4cea12-7e00-d201-e063-6394a90a66912023-11-16WarningsExact identifier
unii: 15FIX9V2JP
Max MineralTITANIUM DIOXIDE, ZINC OXIDEPeter Thomas Roth Labs, LLC0980992c-6488-2fa1-e063-6294a90a41ea2023-11-14WarningsExact identifier
unii: 15FIX9V2JP
Tropical Sands, SPF-50 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.493551d0-10a0-3d78-e054-00144ff8d46c2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.494a7886-d677-1648-e054-00144ff8d46c2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.ab691543-e37a-487a-912e-56d2e0e4d30a2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
PURE HAVEN BODY SPF 30TITANIUM DIOXIDE, ZINC OXIDEPure haven, LLC6f298fcd-8a97-8f66-e053-2991aa0adb102023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Sunstation All-Natural SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDESunstation USA, LLC499d366a-a7f1-6070-e054-00144ff88e882023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Pure Haven EssentialsTITANIUM DIOXIDE, ZINC OXIDEPure Haven LLC4bccc017-266d-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDEKapa'ihi, Inc66e5eb1b-4ef0-459d-8428-b3e2f221bc852023-11-11WarningsExact identifier
unii: 15FIX9V2JP
YOU-V SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEYouV, LLC290cd617-aa90-4f10-8a1d-d8954b9270042023-11-11WarningsExact identifier
unii: 15FIX9V2JP
OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.743f3d23-0f5c-4724-9f69-411c109506e12023-11-11WarningsExact identifier
unii: 15FIX9V2JP
ONCODERM Rx Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEOncoderm, LLC9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
PROJECT REEF Mineral Sunscreen SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC87b9170c-956e-4aa2-9416-da00cca81b582023-11-11WarningsExact identifier
unii: 15FIX9V2JP
DERMAKA Broad Spectrum SPF-42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS32b892fd-c68f-4670-bbaa-0b3de57128492023-11-11WarningsExact identifier
unii: 15FIX9V2JP
WILMA SCHUMANN Moisture Protektiv Day Cream SPF-20OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDESKINMETICS INC4a719986-d1d0-4156-b803-04004b7215042023-11-11WarningsExact identifier
unii: 15FIX9V2JP
DERMAKA Broad Spectrum SPF-42 Sunscreen UntintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9aa24e1f-e338-4947-a437-554fb6b227a22023-11-11WarningsExact identifier
unii: 15FIX9V2JP
TRENDY JOHN SPF-32 Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETRENDY JOHN LLC80dccecb-fbb3-4af6-9cb4-6acea733e9962023-11-11WarningsExact identifier
unii: 15FIX9V2JP
KOVR All-Natural SPF-30 Moisturizing Sunscreen for WomenTITANIUM DIOXIDE, ZINC OXIDEACTIVE LIFE INC0ddc3bb9-595e-4ebd-ad3e-df4d94fd34ed2023-11-11WarningsExact identifier
unii: 15FIX9V2JP
Personalized Day Moisturizer with SPFTITANIUM DIOXIDE, ZINC OXIDEProven Skincare3b6546ed-22ee-48e6-83cc-5cbadf5674992023-11-10WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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