FDA.reportPublic FDA data

NDC 16729-433-01 - EZETIMIBE

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
16729-433
Requested NDC
16729-433-01
Package NDCs from labels
16729-433-10, 16729-433-15, 16729-433-01, 16729-433-16, 16729-433-17
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2025-10-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EZETIMIBE - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2025-10-14HUMAN PRESCRIPTION DRUG LABEL
EZETIMIBE - REMEDYREPACK INC.REMEDYREPACK INC.2024-04-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-433-01EZETIMIBE100 in 1 BOTTLETABLET10010
16729-433-10EZETIMIBE30 in 1 BOTTLETABLET3010
16729-433-15EZETIMIBE90 in 1 BOTTLETABLET9010
16729-433-16EZETIMIBE500 in 1 BOTTLETABLET50010
16729-433-17EZETIMIBE1000 in 1 BOTTLETABLET100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-433EZETIMIBE TABLET [ACCORD HEALTHCARE INC.]9Current NDC, Legacy NDC, 5 package rows20240712_ceecdbe9-5404-4a93-a488-9211cd103058.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-433-10EA - Each16729-43368b14c59-c681-4e1a-a609-b92c4438da6412019-11-12
16729-433-15EA - Each16729-433e0a39356-e208-4116-b8a5-86069ba3e50b12019-11-12
16729-433-16EA - Each16729-433e7d2fc2b-15ba-413b-ae18-901ae7858a9812019-11-12

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 4 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 368GB5141J
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: 6OZP39ZG8H
EzetimibeEZETIMIBEProficient Rx LPfbbe54c3-59a1-436c-aba8-188ba7ca70e02022-08-01Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: 6OZP39ZG8H
EzetimibeEZETIMIBEProficient Rx LP5cbd9bce-e02d-440f-95d5-4eb958d2f4f32019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24

Reported adverse events (FAERS/openFDA)#

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