FDA.reportPublic FDA data

NDC 71335-2123-03 - 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
71335-2123
Requested NDC
71335-2123-03
Package NDCs from labels
71335-2123-1, 71335-2123-2, 71335-2123-3, 71335-2123-4, 71335-2123-5, 71335-2123-03
Manufacturer
Bryant Ranch Prepack
Effective date
2025-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ezetimibe - Bryant Ranch PrepackBryant Ranch Prepack2025-05-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2123-1Ezetimibe30 in 1 BOTTLETABLET30103
71335-2123-2Ezetimibe90 in 1 BOTTLETABLET90103
71335-2123-3Ezetimibe28 in 1 BOTTLETABLET28103
71335-2123-4Ezetimibe18 in 1 BOTTLETABLET18103
71335-2123-5Ezetimibe60 in 1 BOTTLETABLET60103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2123EZETIMIBE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20250514_3a80b668-51cd-42be-8497-8712b0508422.zip

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 1 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINNORTHSTAR RX LLC52a46269-2262-4052-a3ff-5455523f591f2026-09-01Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
EzetimibeEZETIMIBEA-S Medication Solutions090776cf-f211-49a3-a993-ff5d707311f22026-07-06Warnings, Adverse reactionsExact identifier
application number: ANDA209838
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEA-S Medication Solutionsa1cc2018-72a3-48bc-90de-c460f224cf5a2026-07-06Warnings, Adverse reactionsExact identifier
application number: ANDA209838
rxcui: 349556
unii: EOR26LQQ24
NexlizetBEMPEDOIC ACID AND EZETIMIBEEsperion Therapeutics, Inc.3fa2108c-0300-47b8-9d34-f762af7c93c62026-06-25Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
EzetimibeEZETIMIBEMajor Pharmaceuticalse257ed7f-5015-4f1d-93f4-5adf5797643d2026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EZETIMIBEEZETIMIBEBryant Ranch Prepack02b00cb2-7253-4fb4-a216-53691a929a282026-02-17Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINA-S Medication Solutions2ce219a2-1eeb-4ece-bb87-3810e593ca512026-02-06Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
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
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
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
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

Reported adverse events (FAERS/openFDA)#

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