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 3 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EZETIMIBEEZETIMIBECamber Pharmaceuticals, Inc.c07fe2e0-dad4-48b5-8a07-7d57a4035ccd2024-07-19Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEBryant Ranch Prepackd6b4fd12-9954-42ba-b42a-56f3747c47ff2024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEScieGen Pharmaceuticals Inc11de499b-ad8a-46a6-9021-c8eba72ae4142024-06-12Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEMacleods Pharmaceuticals Limitedebe3fa4e-82c4-4a9a-9aec-f64019391f4e2024-05-13Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 368GB5141J
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINGlenmark Pharmaceuticals Inc., USA32d0e130-1211-44ca-be60-5379ffec96fd2024-04-30Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
EzetimibeEZETIMIBEOrient Pharma Co., Ltd.b6e77d9b-a553-63e0-e053-2a95a90a18fe2024-04-15Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEBryant Ranch Prepack11828685-dc27-42d8-a6ff-f110018207d12024-04-04Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEBryant Ranch Prepack03609879-bad2-4e75-83fe-1e1a2fd300c32024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 368GB5141J
EzetimibeEZETIMIBEGolden State Medical Supply, Inc.4a78aa8d-1fe0-4df0-a15b-2350c15aead12024-03-25Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
ezetimibeEZETIMIBEQuallent Pharmaceuticals Health LLC68247ce8-e812-42f2-a3ba-0f6e49acca632024-03-20Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEOhm Laboratories Inc.5b3842f6-c80a-47b8-8a82-b69e465b05f72024-03-05Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
ezetimibeEZETIMIBEZydus Pharmaceuticals USA Inc.f852b12f-e25f-415b-b1e2-58955d6095072024-02-27Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEA-S Medication Solutions57d19491-cba1-4720-b69d-4815744592012024-02-22Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINA-S Medication Solutions2c936363-b483-46c6-936c-a07d8ab0280c2024-01-16Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
EzetimibeEZETIMIBEProficient Rx LP8b128e52-5d0d-4536-aa1f-be192d0989ad2024-01-01Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEA-S Medication Solutions9a04678f-e961-45aa-b3bb-e38e66856edc2023-09-21Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 368GB5141J
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 368GB5141J

Reported adverse events (FAERS/openFDA)#

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