FDA.reportPublic FDA data

NDC 71335-1127-03 - 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
71335-1127
Requested NDC
71335-1127-03
Package NDCs from labels
71335-1127-1, 71335-1127-2, 71335-1127-3, 71335-1127-4, 71335-1127-5, 71335-1127-03
Manufacturer
Bryant Ranch Prepack
Effective date
2025-07-17
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 Prepack2025-07-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1127-1Ezetimibe30 in 1 BOTTLETABLET306
71335-1127-2Ezetimibe90 in 1 BOTTLETABLET906
71335-1127-3Ezetimibe28 in 1 BOTTLETABLET286
71335-1127-4Ezetimibe18 in 1 BOTTLETABLET186
71335-1127-5Ezetimibe60 in 1 BOTTLETABLET606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1127EZETIMIBE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 5 package rows20240824_c92292f5-5444-4247-927e-db7bf6816109.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1127-2EA - Each71335-1127e62c4798-8202-4d7d-adbd-98b70f6c85cb12025-08-11

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 5 · 91 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
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
EzetimibeEZETIMIBEA-S Medication Solutions090776cf-f211-49a3-a993-ff5d707311f22026-07-06Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEA-S Medication Solutionsa1cc2018-72a3-48bc-90de-c460f224cf5a2026-07-06Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
NexlizetBEMPEDOIC ACID AND EZETIMIBEEsperion Therapeutics, Inc.3fa2108c-0300-47b8-9d34-f762af7c93c62026-06-25Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
EzetimibeEZETIMIBEMajor Pharmaceuticalse257ed7f-5015-4f1d-93f4-5adf5797643d2026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA209234
rxcui: 349556
unii: EOR26LQQ24
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: 3NXW29V3WO
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: 3NXW29V3WO
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

Reported adverse events (FAERS/openFDA)#

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