FDA.reportPublic FDA data

EZETIMIBE

Product NDC
16729-433
11-digit product format
167290433
Labeler code
16729
Product ID
16729-433_411f7e5b-cb87-22d4-e063-6394a90a518c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EZETIMIBE
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA211550
Marketing category
ANDA
Marketing start
2019-10-07
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
16729-433-01EZETIMIBE100 in 1 BOTTLETABLET10010
16729-433-10EZETIMIBE30 in 1 BOTTLETABLET3010
16729-433-15EZETIMIBE90 in 1 BOTTLETABLET9010
16729-433-16EZETIMIBE500 in 1 BOTTLETABLET50010
16729-433-17EZETIMIBE1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-433-10EA - Each16729-43368b14c59-c681-4e1a-a609-b92c4438da6412019-11-12
16729-433-15EA - Each16729-433e0a39356-e208-4116-b8a5-86069ba3e50b12019-11-12
16729-433-16EA - Each16729-433e7d2fc2b-15ba-413b-ae18-901ae7858a9812019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-433EZETIMIBE TABLET [ACCORD HEALTHCARE INC.]9Current NDC, Legacy NDC, 5 package rows20240712_ceecdbe9-5404-4a93-a488-9211cd103058.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSNceecdbe9-5404-4a93-a488-9211cd10305810
349556ezetimibe 10 MG Oral TabletSCDceecdbe9-5404-4a93-a488-9211cd10305810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-433-0116729043301100 in 1 BOTTLEHistorical
16729-433-101672904331030 TABLET in 1 BOTTLE (16729-433-10) 30 tablet2019-11-010000-00-00NoNoCurrent
16729-433-151672904331590 TABLET in 1 BOTTLE (16729-433-15) 90 tablet2019-10-070000-00-00NoNoCurrent
16729-433-1616729043316500 TABLET in 1 BOTTLE (16729-433-16) 500 tablet2019-10-170000-00-00NoNoCurrent
16729-433-17167290433171000 in 1 BOTTLEHistorical