FDA.reportPublic FDA data

NDC 16729-433-01 - 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
16729-433
Requested NDC
16729-433-01
Package NDCs from labels
16729-433-10, 16729-433-15, 16729-433-01, 16729-433-16, 16729-433-17
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2025-10-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EZETIMIBE - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2025-10-14HUMAN PRESCRIPTION DRUG LABEL
EZETIMIBE - REMEDYREPACK INC.REMEDYREPACK INC.2024-04-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-433-01EZETIMIBE100 in 1 BOTTLETABLET10010
16729-433-10EZETIMIBE30 in 1 BOTTLETABLET3010
16729-433-15EZETIMIBE90 in 1 BOTTLETABLET9010
16729-433-16EZETIMIBE500 in 1 BOTTLETABLET50010
16729-433-17EZETIMIBE1000 in 1 BOTTLETABLET100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-433EZETIMIBE TABLET [ACCORD HEALTHCARE INC.]9Current NDC, Legacy NDC, 5 package rows20240712_ceecdbe9-5404-4a93-a488-9211cd103058.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-433-10EA - Each16729-43368b14c59-c681-4e1a-a609-b92c4438da6412019-11-12
16729-433-15EA - Each16729-433e0a39356-e208-4116-b8a5-86069ba3e50b12019-11-12
16729-433-16EA - Each16729-433e7d2fc2b-15ba-413b-ae18-901ae7858a9812019-11-12

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 4 · 68 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 Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
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 Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
EzetimibeEZETIMIBEMajor Pharmaceuticalse257ed7f-5015-4f1d-93f4-5adf5797643d2026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
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
application number: ANDA211550
ndc (package): 16729-433-01
ndc (package): 16729-433-10
ndc (package): 16729-433-17
ndc (package): 16729-433-15
ndc (package): 16729-433-16
ndc (product): 16729-433
ndc11 (package): 16729043301
rxcui: 349556
spl id: 411f7e5b-cb87-22d4-e063-6394a90a518c
spl set id: ceecdbe9-5404-4a93-a488-9211cd103058
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

Reported adverse events (FAERS/openFDA)#

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