FDA.reportPublic FDA data

NDC 50090-3422-01 - 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
50090-3422
Requested NDC
50090-3422-01
Package NDCs from labels
50090-3422-0, 50090-3422-1, 50090-3422-01
Manufacturer
A-S Medication Solutions
Effective date
2024-09-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ezetimibe - A-S Medication SolutionsA-S Medication Solutions2024-09-29Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3422-0Ezetimibe30 in 1 BOTTLETABLET309
50090-3422-1Ezetimibe90 in 1 BOTTLETABLET909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3422EZETIMIBE TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20241003_63ecbbf1-a6de-493f-9710-812ff45cb4d3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3422-0EA - Each50090-34225b69c374-bd17-4b9b-8a49-a7a0b7635a4412019-05-02
50090-3422-1EA - Each50090-3422413c97f7-ed5b-483b-8183-131d398cf92b12019-05-02

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 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
application number: ANDA209838
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
application number: ANDA209838
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
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
EzetimibeEZETIMIBEProficient Rx LPfbbe54c3-59a1-436c-aba8-188ba7ca70e02022-08-01Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
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.