FDA.reportPublic FDA data

NDC 70771-1109-2 - 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
70771-1109
Requested NDC
70771-1109-2
Package NDCs from labels
70771-1109-3, 70771-1109-9, 70771-1109-1, 70771-1109-5, 70771-1109-0, 70771-1109-2, 70771-1109-4
Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ezetimibe - Zydus Lifesciences LimitedZydus Lifesciences Limited2024-11-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1109-0ezetimibe1000 in 1 BOTTLETABLET10005
70771-1109-1ezetimibe100 in 1 BOTTLETABLET1005
70771-1109-2ezetimibe10 in 1 BLISTER PACKTABLET105
70771-1109-3ezetimibe30 in 1 BOTTLETABLET305
70771-1109-4ezetimibe10 in 1 CARTONTABLET105
70771-1109-5ezetimibe500 in 1 BOTTLETABLET5005
70771-1109-9ezetimibe90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1109EZETIMIBE TABLET [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 7 package rows20241201_de814dcd-4759-4e9c-a650-335fb885a79d.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 4 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
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
EzetimibeEZETIMIBEAscend Laboratories, LLC206d702c-b09a-4555-972b-6555d6d6d6e62025-06-13Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEBryant Ranch Prepack3a80b668-51cd-42be-8497-8712b05084222025-05-12Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINAscend Laboratories, LLCc90e8c96-e130-42d7-bf0d-5833652e40d52025-05-02Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
EzetimibeEZETIMIBEAurobindo Pharma Limited726b1e63-437a-4b3b-b773-3ac47a5c0f382025-03-13Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBENorthStar Rx LLC5f5644a9-e019-4e5d-ab6f-3d30b1024c5a2025-03-13Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
EzetimibeEZETIMIBEProficient Rx LP55b18d8f-40e0-48ba-baf1-79a0d1bb2ee22025-03-01Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
EzetimibeEZETIMIBEAmneal Pharmaceuticals NY LLC3fadf4e9-017d-4ccd-91dc-a89b981eb1382025-02-10Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 368GB5141J
ezetimibeEZETIMIBEZydus Lifesciences Limitedde814dcd-4759-4e9c-a650-335fb885a79d2024-11-28Exact identifier
application number: ANDA204331
ndc (package): 70771-1109-9
ndc (package): 70771-1109-5
ndc (package): 70771-1109-4
ndc (package): 70771-1109-1
ndc (package): 70771-1109-2
ndc (package): 70771-1109-3
ndc (package): 70771-1109-0
ndc (product): 70771-1109
ndc11 (package): 70771110902
rxcui: 349556
spl id: 5862da1c-e73d-44ff-a961-aaef469ed646
spl set id: de814dcd-4759-4e9c-a650-335fb885a79d
unii: EOR26LQQ24
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
Ezetimibe and SimvastatinEZETIMIBE AND SIMVASTATINAurobindo Pharma Limited79dadfde-35c7-4937-9c82-1728fb6be2fb2024-10-22Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
EzetimibeEZETIMIBEA-S Medication Solutions5877150f-2807-435e-8e5b-a07dc7dbfd272024-10-21Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24

Reported adverse events (FAERS/openFDA)#

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