FDA.reportPublic FDA data

Ezetimibe

Product NDC
63629-7413
11-digit product format
636297413
Labeler code
63629
Product ID
63629-7413_359e02cb-5fc3-494a-9bf8-d2578aae8ee8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203931
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
63629-7413-1Ezetimibe30 in 1 BOTTLETABLET304
63629-7413-2Ezetimibe90 in 1 BOTTLETABLET904
63629-7413-3Ezetimibe28 in 1 BOTTLETABLET284
63629-7413-4Ezetimibe18 in 1 BOTTLETABLET184
63629-7413-5Ezetimibe60 in 1 BOTTLETABLET604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7413EZETIMIBE TABLET [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 5 package rows20240518_03609879-bad2-4e75-83fe-1e1a2fd300c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN03609879-bad2-4e75-83fe-1e1a2fd300c34
349556ezetimibe 10 MG Oral TabletSCD03609879-bad2-4e75-83fe-1e1a2fd300c34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7413-16362974130130 TABLET in 1 BOTTLE (63629-7413-1) 30 tablet2017-10-100000-00-00NoNoCurrent
63629-7413-26362974130290 TABLET in 1 BOTTLE (63629-7413-2) 90 tablet2017-10-100000-00-00NoNoCurrent
63629-7413-36362974130328 TABLET in 1 BOTTLE (63629-7413-3) 28 tablet2024-04-030000-00-00NoNoCurrent
63629-7413-46362974130418 TABLET in 1 BOTTLE (63629-7413-4) 18 tablet2024-04-030000-00-00NoNoCurrent
63629-7413-56362974130560 TABLET in 1 BOTTLE (63629-7413-5) 60 tablet2024-04-030000-00-00NoNoCurrent