FDA.reportPublic FDA data

NDC 50090-3657-01 - 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
50090-3657
Requested NDC
50090-3657-01
Package NDCs from labels
50090-3657-1, 50090-3657-0, 50090-3657-01
Manufacturer
A-S Medication Solutions
Effective date
2023-09-21
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 Solutions2023-09-21Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-3657-02023-02-07These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS. EZETIMIBE tablets, for oral use. Initial U.S. Approval: 2002
50090-3657-12023-02-07These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS. EZETIMIBE tablets, for oral use. Initial U.S. Approval: 2002
50090-3657-02023-01-30These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS. EZETIMIBE tablets, for oral use. Initial U.S. Approval: 2002
50090-3657-12023-01-30These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS. EZETIMIBE tablets, for oral use. Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3657-0Ezetimibe30 in 1 BOTTLE, PLASTICTABLET307
50090-3657-1Ezetimibe90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3657EZETIMIBE TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20230922_9a04678f-e961-45aa-b3bb-e38e66856edc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3657-0EA - Each50090-3657363b8901-cab8-402f-9a34-1cc6a598f89112021-10-08
50090-3657-1EA - Each50090-3657ba175e5c-8798-4ee5-ae58-8e41f3b18fc912021-10-08

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 5 · 91 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VYTORINEZETIMIBE AND SIMVASTATINOrganon LLC89b860d2-de83-468e-b7e8-76aeec2edca22026-01-21Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
EzetimibeEZETIMIBEAvPAK6fcbfbd9-6e09-8224-e053-2a91aa0a82262026-01-13Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
unii: 3NXW29V3WO
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Harris Teeter Eye Drops Artificial TearsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Harris Teeter, LLC.f82957d9-c4ad-a914-e053-6294a90aac502025-12-30WarningsExact identifier
unii: 3NXW29V3WO
CVS Gentle TearsDEXTRAN 70, HYPROMELLOSECVS Pharmacy, Inc.9b1ea0eb-c34f-6603-e053-2995a90a6a952025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
unii: 3NXW29V3WO
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: 3NXW29V3WO
ZetiaEZETIMIBEOrganon LLC174e45e0-45bb-48b7-9e60-8f6cfc1d22bb2025-11-25Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINGolden State Medical Supply, Inc.88cd0e7b-e8dc-6125-e053-2a95a90aaa272025-11-24Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
EzetimibeEZETIMIBEMarlex Pharmaceuticals, Inc.109a22f4-a7cb-96c6-e063-6394a90ad7f62025-11-07Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EZETIMIBEEZETIMIBEAccord Healthcare Inc.ceecdbe9-5404-4a93-a488-9211cd1030582025-10-14Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEAmerican Health Packaging0e9a9eda-1b2a-4475-8483-0f410a17c5242025-10-14Warnings, Adverse reactionsExact identifier
application number: ANDA209234
rxcui: 349556
unii: EOR26LQQ24
EZETIMIBEEZETIMIBEA-S Medication Solutions4cfda5aa-e21a-47b2-b296-88d8336298ef2025-10-14Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EZETIMIBEEZETIMIBEA-S Medication Solutions4158aa71-3540-4912-b909-7491e5a1429c2025-10-14Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEA-S Medication Solutionsdd8a09cb-f014-4650-9da2-4ad1581c97412025-10-10Warnings, Adverse reactionsExact identifier
application number: ANDA209234
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

Reported adverse events (FAERS/openFDA)#

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