FDA.reportPublic FDA data

Ezetimibe

Product NDC
71335-0684
11-digit product format
713350684
Labeler code
71335
Product ID
71335-0684_2b1e3823-0a7c-411d-941a-2ee70251a43f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208803
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0684-1Ezetimibe30 in 1 BOTTLETABLET306
71335-0684-2Ezetimibe90 in 1 BOTTLETABLET906
71335-0684-3Ezetimibe28 in 1 BOTTLETABLET286
71335-0684-4Ezetimibe18 in 1 BOTTLETABLET186
71335-0684-5Ezetimibe60 in 1 BOTTLETABLET606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0684EZETIMIBE TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 5 package rows20240724_d6b4fd12-9954-42ba-b42a-56f3747c47ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSNd6b4fd12-9954-42ba-b42a-56f3747c47ff6
349556ezetimibe 10 MG Oral TabletSCDd6b4fd12-9954-42ba-b42a-56f3747c47ff6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0684-17133506840130 TABLET in 1 BOTTLE (71335-0684-1) 30 tablet2018-03-020000-00-00NoNoCurrent
71335-0684-27133506840290 TABLET in 1 BOTTLE (71335-0684-2) 90 tablet2018-02-120000-00-00NoNoCurrent
71335-0684-37133506840328 TABLET in 1 BOTTLE (71335-0684-3) 28 tablet2024-07-090000-00-00NoNoCurrent
71335-0684-47133506840418 TABLET in 1 BOTTLE (71335-0684-4) 18 tablet2024-07-090000-00-00NoNoCurrent
71335-0684-57133506840560 TABLET in 1 BOTTLE (71335-0684-5) 60 tablet2023-02-170000-00-00NoNoCurrent