FDA.reportPublic FDA data

NDC 69238-1154-01 - 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
69238-1154
Requested NDC
69238-1154-01
Package NDCs from labels
69238-1154-3, 69238-1154-9, 69238-1154-5, 69238-1154-1, 69238-1154-01
Manufacturer
AvPAK
Effective date
2026-01-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ezetimibe - AvPAKAvPAK2026-01-13HUMAN PRESCRIPTION DRUG LABEL
Ezetimibe - Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private LimitedAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited2025-02-10HUMAN PRESCRIPTION DRUG LABEL
Ezetimibe - Bryant Ranch PrepackBryant Ranch Prepack2024-07-09HUMAN PRESCRIPTION DRUG LABEL
Ezetimibe - A-S Medication SolutionsA-S Medication Solutions2019-02-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1154-1Ezetimibe1000 in 1 BOTTLETABLET100014
69238-1154-3Ezetimibe30 in 1 BOTTLETABLET3014
69238-1154-5Ezetimibe500 in 1 BOTTLETABLET50014
69238-1154-9Ezetimibe90 in 1 BOTTLETABLET9014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1154EZETIMIBE TABLET [AMNEAL PHARMACEUTICALS NY LLC]14Current NDC, Legacy NDC, 4 package rows20250402_3fadf4e9-017d-4ccd-91dc-a89b981eb138.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1154-3EA - Each69238-1154c085ae9c-14b1-431e-8feb-02430c85003f12017-07-07
69238-1154-5EA - Each69238-11543880b46a-8c4f-43aa-b202-e2d521268ae312017-07-07
69238-1154-9EA - Each69238-1154b92666b0-31d0-4f26-ac13-b0a34533e2df12017-07-07

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 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINA-S Medication Solutions2ce219a2-1eeb-4ece-bb87-3810e593ca512026-02-06Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
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
application number: ANDA208803
ndc (package): 50268-298-12
ndc (package): 50268-298-11
ndc (product): 50268-298
rxcui: 349556
spl id: 484a0aba-8404-df2e-e063-6394a90aea0b
spl set id: 6fcbfbd9-6e09-8224-e053-2a91aa0a8226
unii: EOR26LQQ24
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
unii: FZ989GH94E
Good Sense Artificial TearsPOLYVINYL ALCOHOL, POVIDONEGeiss, Destin & Dunn, Inc.9b243301-2e4b-5706-e053-2995a90a9b902025-12-30WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLGeiss, Derstin & Dunn, Inc.9b34de99-13df-201a-e053-2a95a90ae5592025-12-30WarningsExact identifier
unii: FZ989GH94E
Discount Drug Mart Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.f75c2f84-a28c-5807-e053-6294a90a22952025-12-30WarningsExact identifier
unii: FZ989GH94E
Exchange Select Eye Drops Advanced Relief MoisturizerDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLArmy and Air Force Exchange Service9e475240-2df1-9bee-e053-2995a90a8d4b2025-12-30WarningsExact identifier
unii: FZ989GH94E
Family Wellness Artificial TearsPOLYVINYL ALCOHOL, POVIDONEFamily Dollar Services, Inc.facd329b-1923-61df-e053-6294a90ab7382025-12-30WarningsExact identifier
unii: FZ989GH94E
DG Health Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLDolgencorp LLC9c62f8a3-7cf5-40f9-e053-2a95a90afd862025-12-30WarningsExact identifier
unii: FZ989GH94E
Artificial TearsPOLYVINYL ALCOHOL, POVIDONEKC Pharmaceuticals, Inc.eb6eb6c4-1609-407b-84e4-c7509811f3c02025-12-30WarningsExact identifier
unii: FZ989GH94E
Medics Choice Eye Drops AdvancedTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONEKC Pharmaceuticals, Inc.ab906fd8-265c-4359-a920-d626366e245c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Publix Artificial Tears Eye DropsPOLYVINYL ALCOHOL, POVIDONEPublix Super Markets, Inc.f5d1394b-0fe8-c372-e053-2a95a90a1f782025-12-30WarningsExact identifier
unii: FZ989GH94E
Best Choice Artificial TearsPOLYVINYL ALCOHOL, POVIDONEBest Choicef5ba63f3-7966-81fe-e053-2995a90a342c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Publix Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEPublix Super Markets, Inc.f7b0c3d6-0324-46c3-e053-6394a90a82412025-12-30WarningsExact identifier
unii: FZ989GH94E
Kroger Eye Drops Artificial TearsPOLYVINYL ALCOHOL, POVIDONEThe Kroger Companyf76f08c5-0111-8bc5-e053-6294a90a16ee2025-12-30WarningsExact identifier
unii: FZ989GH94E
Core Values Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDELiberty Procurement Co., Inc.f76dfeca-4e86-0b5d-e053-6294a90a29b92025-12-30WarningsExact identifier
unii: FZ989GH94E
Best Choice Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEValu Merchandisers, Co.f7491a17-8035-5a3c-e053-6294a90a615c2025-12-30WarningsExact identifier
unii: FZ989GH94E
Winco Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLWinCo Foods, LLCf10778c8-14fe-4852-8b73-42db502fd2bc2025-12-30WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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