FDA.reportPublic FDA data

NDC 16729-348-45 - 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
16729-348-45
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 104 of 104 · 2,064 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Baby Tear Free SPF 50TITANIUM DIOXIDE, ZINC OXIDEMeijer Distributing Inc.2434de23-bcc9-4a83-9945-16fc3f2b8c612016-06-01WarningsExact identifier
unii: 15FIX9V2JP
TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 Sunscreen (Tinted)OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.6a996e03-907f-4e6a-b232-0892b86956b02015-08-21WarningsExact identifier
unii: 15FIX9V2JP
Renewal Firming Day Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEBURT'S BEES, INC.18ceb5d8-4b76-6a54-e054-00144ff88e882015-06-18WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD.30468afc-9616-4765-b046-12e97a0a78272010-12-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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