FDA.reportPublic FDA data

NDC 68382-773-30 - 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
68382-773
Requested NDC
68382-773-30
Package NDCs from labels
68382-773-06, 68382-773-16, 68382-773-01, 68382-773-05, 68382-773-10, 68382-773-30, 68382-773-77
Manufacturer
Safecor Health, LLC
Effective date
2026-09-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ezetimibe - Safecor Health, LLCSafecor Health, LLC2026-09-10HUMAN PRESCRIPTION DRUG LABEL
ezetimibe - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2024-02-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-773-01ezetimibe100 in 1 BOTTLETABLET1006
68382-773-05ezetimibe500 in 1 BOTTLETABLET5006
68382-773-06ezetimibe30 in 1 BOTTLETABLET306
68382-773-10ezetimibe1000 in 1 BOTTLETABLET10006
68382-773-16ezetimibe90 in 1 BOTTLETABLET906
68382-773-30ezetimibe10 in 1 BLISTER PACKTABLET106
68382-773-77ezetimibe10 in 1 CARTONTABLET106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-773EZETIMIBE TABLET [ZYDUS PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 7 package rows20240302_f852b12f-e25f-415b-b1e2-58955d609507.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-773-05EA - Each68382-7734e473476-0aab-418f-b254-bf755af276ff12018-04-19
68382-773-06EA - Each68382-7736710b7a0-01f6-4ddf-a21e-ea2732ff6d5112018-04-19
68382-773-16EA - Each68382-7737dc770c6-8fcb-4b9f-a6b3-a8980b3dfcfb12018-04-19

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 7 · 126 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
5a86812c-e05e-191d-e063-6394a90a5f4b6407d7f3-fd92-4c36-b561-f95ab7ebe0552026-09-02Warnings, Adverse reactionsExact identifier
spl id: 5a86812c-e05e-191d-e063-6394a90a5f4b
spl set id: 6407d7f3-fd92-4c36-b561-f95ab7ebe055
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINNORTHSTAR RX LLC52a46269-2262-4052-a3ff-5455523f591f2026-09-01Warnings, Adverse reactionsExact identifier
unii: EOR26LQQ24
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
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: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
EzetimibeEZETIMIBEMajor Pharmaceuticalse257ed7f-5015-4f1d-93f4-5adf5797643d2026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 349556
unii: EOR26LQQ24
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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