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 2 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EzetimibeEZETIMIBEA-S Medication Solutionsdd8a09cb-f014-4650-9da2-4ad1581c97412025-10-10Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINDr.Reddys Laboratories Inc023ca87a-1b04-8c17-dc4f-e2758b0771e22025-07-18Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
EzetimibeEZETIMIBEBryant Ranch Prepackc92292f5-5444-4247-927e-db7bf68161092025-07-17Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEAscend Laboratories, LLC206d702c-b09a-4555-972b-6555d6d6d6e62025-06-13Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEBryant Ranch Prepack3a80b668-51cd-42be-8497-8712b05084222025-05-12Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINAscend Laboratories, LLCc90e8c96-e130-42d7-bf0d-5833652e40d52025-05-02Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
EzetimibeEZETIMIBEAurobindo Pharma Limited726b1e63-437a-4b3b-b773-3ac47a5c0f382025-03-13Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBENorthStar Rx LLC5f5644a9-e019-4e5d-ab6f-3d30b1024c5a2025-03-13Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEProficient Rx LP55b18d8f-40e0-48ba-baf1-79a0d1bb2ee22025-03-01Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEAmneal Pharmaceuticals NY LLC3fadf4e9-017d-4ccd-91dc-a89b981eb1382025-02-10Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 368GB5141J
ezetimibeEZETIMIBEZydus Lifesciences Limitedde814dcd-4759-4e9c-a650-335fb885a79d2024-11-28Exact identifier
rxcui: 349556
unii: EOR26LQQ24
253d0098-3de3-8a45-e063-6294a90ae4c83c8ac178-1533-4514-a802-94a495996dfe2024-10-24Warnings, Adverse reactionsExact identifier
spl set id: 3c8ac178-1533-4514-a802-94a495996dfe
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINAurobindo Pharma Limited79dadfde-35c7-4937-9c82-1728fb6be2fb2024-10-22Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
EzetimibeEZETIMIBEA-S Medication Solutions5877150f-2807-435e-8e5b-a07dc7dbfd272024-10-21Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEA-S Medication Solutions1afdb764-c5da-4982-beae-9be61bdcbcdc2024-10-21Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEA-S Medication Solutions63ecbbf1-a6de-493f-9710-812ff45cb4d32024-09-29Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 368GB5141J
EzetimibeEZETIMIBEGlenmark Pharmaceuticals Inc., USAac539a72-77e4-419c-b1d9-42002e9cecf72024-07-31Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24

Reported adverse events (FAERS/openFDA)#

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