FDA.reportPublic FDA data

Ezetimibe

Product NDC
71335-0933
11-digit product format
713350933
Labeler code
71335
Product ID
71335-0933_4b23230f-2852-4daa-a5d8-45b5da0fb63e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200831
Marketing category
ANDA
Marketing start
2017-06-12
Substance
EZETIMIBE
Active strength
10 mg/1
Pharmacologic classes
Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ezetimibe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EZETIMIBE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEOR26LQQ24
Rxcui349556

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
93a156a6-903b-1690-4dc3-a57adfaa8c1aProduct name920230322
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b249faa8-b784-47ef-8ad4-031ef248fa73Product name120200626
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0933-12024-05-15C16284748780-11030e365-2dfb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002
71335-0933-22024-05-15C16284748780-11030e365-2dfb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002
71335-0933-32024-05-15C16284748780-11030e365-2dfb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002
71335-0933-42024-05-15C16284748780-11030e365-2dfb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002
71335-0933-52024-05-15C16284748780-11030e365-2dfb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002
71335-0933-12024-01-30C16284748780-11030e365-2dfb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002
71335-0933-22024-01-30C16284748780-11030e365-2dfb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002
71335-0933-32024-01-30C16284748780-11030e365-2dfb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002
71335-0933-42024-01-30C16284748780-11030e365-2dfb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002
71335-0933-52024-01-30C16284748780-11030e365-2dfb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS . EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0933-1Ezetimibe30 in 1 BOTTLETABLET305
71335-0933-2Ezetimibe90 in 1 BOTTLETABLET905
71335-0933-3Ezetimibe28 in 1 BOTTLETABLET285
71335-0933-4Ezetimibe18 in 1 BOTTLETABLET185
71335-0933-5Ezetimibe60 in 1 BOTTLETABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0933EZETIMIBE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 5 package rows20240517_11828685-dc27-42d8-a6ff-f110018207d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN11828685-dc27-42d8-a6ff-f110018207d15
349556ezetimibe 10 MG Oral TabletSCD11828685-dc27-42d8-a6ff-f110018207d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0933-17133509330130 TABLET in 1 BOTTLE (71335-0933-1) 30 tablet2018-08-230000-00-00NoNoCurrent
71335-0933-27133509330290 TABLET in 1 BOTTLE (71335-0933-2) 90 tablet2018-07-310000-00-00NoNoCurrent
71335-0933-37133509330328 TABLET in 1 BOTTLE (71335-0933-3) 28 tablet2021-12-280000-00-00NoNoCurrent
71335-0933-47133509330418 TABLET in 1 BOTTLE (71335-0933-4) 18 tablet2021-12-280000-00-00NoNoCurrent
71335-0933-57133509330560 TABLET in 1 BOTTLE (71335-0933-5) 60 tablet2021-12-280000-00-00NoNoCurrent