FDA.reportPublic FDA data

Ezetimibe

Product NDC
71335-1127
11-digit product format
713351127
Labeler code
71335
Product ID
71335-1127_a25c5ee6-c4fd-4842-8412-ebd8e8085ec0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209234
Marketing category
ANDA
Marketing start
2017-12-23
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
71335-1127-1Ezetimibe30 in 1 BOTTLETABLET306
71335-1127-2Ezetimibe90 in 1 BOTTLETABLET906
71335-1127-3Ezetimibe28 in 1 BOTTLETABLET286
71335-1127-4Ezetimibe18 in 1 BOTTLETABLET186
71335-1127-5Ezetimibe60 in 1 BOTTLETABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1127-2EA - Each71335-1127e62c4798-8202-4d7d-adbd-98b70f6c85cb12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1127EZETIMIBE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 5 package rows20240824_c92292f5-5444-4247-927e-db7bf6816109.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSNc92292f5-5444-4247-927e-db7bf68161096
349556ezetimibe 10 MG Oral TabletSCDc92292f5-5444-4247-927e-db7bf68161096

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1127-17133511270130 TABLET in 1 BOTTLE (71335-1127-1) 30 tablet2019-03-060000-00-00NoNoCurrent
71335-1127-27133511270290 TABLET in 1 BOTTLE (71335-1127-2) 90 tablet2019-02-270000-00-00NoNoCurrent
71335-1127-37133511270328 TABLET in 1 BOTTLE (71335-1127-3) 28 tablet2024-05-300000-00-00NoNoCurrent
71335-1127-47133511270418 TABLET in 1 BOTTLE (71335-1127-4) 18 tablet2024-05-300000-00-00NoNoCurrent
71335-1127-57133511270560 TABLET in 1 BOTTLE (71335-1127-5) 60 tablet2020-06-170000-00-00NoNoCurrent