FDA.reportPublic FDA data

Ezetimibe

Product NDC
71335-2123
11-digit product format
713352123
Labeler code
71335
Product ID
71335-2123_34f7bf4b-9cfb-6931-e063-6394a90abab1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209838
Marketing category
ANDA
Marketing start
2017-08-25
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2123-1Ezetimibe30 in 1 BOTTLETABLET30103
71335-2123-2Ezetimibe90 in 1 BOTTLETABLET90103
71335-2123-3Ezetimibe28 in 1 BOTTLETABLET28103
71335-2123-4Ezetimibe18 in 1 BOTTLETABLET18103
71335-2123-5Ezetimibe60 in 1 BOTTLETABLET60103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2123EZETIMIBE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20250514_3a80b668-51cd-42be-8497-8712b0508422.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN3a80b668-51cd-42be-8497-8712b0508422103
349556ezetimibe 10 MG Oral TabletSCD3a80b668-51cd-42be-8497-8712b0508422103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2123-17133521230130 TABLET in 1 BOTTLE (71335-2123-1) 30 tablet2022-08-310000-00-00NoNoCurrent
71335-2123-27133521230290 TABLET in 1 BOTTLE (71335-2123-2) 90 tablet2022-08-240000-00-00NoNoCurrent
71335-2123-37133521230328 TABLET in 1 BOTTLE (71335-2123-3) 28 tablet2024-04-030000-00-00NoNoCurrent
71335-2123-47133521230418 TABLET in 1 BOTTLE (71335-2123-4) 18 tablet2024-04-030000-00-00NoNoCurrent
71335-2123-57133521230560 TABLET in 1 BOTTLE (71335-2123-5) 60 tablet2023-11-220000-00-00NoNoCurrent