EZETIMIBE

Product NDC
71335-3092
11-digit product format
713353092
Labeler code
71335
Product ID
71335-3092_1329fd6e-ab21-40be-8584-6886362ab4b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EZETIMIBE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210859
Marketing category
ANDA
Marketing start
2022-07-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EZETIMIBE
Listing expiration
2027-12-31

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
71335-3092-1EZETIMIBE30 in 1 BOTTLETABLET301
71335-3092-2EZETIMIBE90 in 1 BOTTLETABLET901
71335-3092-3EZETIMIBE28 in 1 BOTTLETABLET281
71335-3092-4EZETIMIBE18 in 1 BOTTLETABLET181
71335-3092-5EZETIMIBE60 in 1 BOTTLETABLET601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN02b00cb2-7253-4fb4-a216-53691a929a281
349556ezetimibe 10 MG Oral TabletSCD02b00cb2-7253-4fb4-a216-53691a929a281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3092-17133530920130 TABLET in 1 BOTTLE (71335-3092-1) 30 tablet2026-02-17NoNoCurrent
71335-3092-27133530920290 TABLET in 1 BOTTLE (71335-3092-2) 90 tablet2026-02-17NoNoCurrent
71335-3092-37133530920328 TABLET in 1 BOTTLE (71335-3092-3) 28 tablet2026-02-17NoNoCurrent
71335-3092-47133530920418 TABLET in 1 BOTTLE (71335-3092-4) 18 tablet2026-02-17NoNoCurrent
71335-3092-57133530920560 TABLET in 1 BOTTLE (71335-3092-5) 60 tablet2026-02-17NoNoCurrent