FDA.reportPublic FDA data

Ezetimibe

Product NDC
50228-379
11-digit product format
502280379
Labeler code
50228
Product ID
50228-379_1ab4be5f-4926-88ad-e063-6294a90a0c81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals Inc
Application
ANDA210673
Marketing category
ANDA
Marketing start
2020-10-23
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
50228-379-05Ezetimibe500 in 1 BOTTLETABLET5003
50228-379-10Ezetimibe1000 in 1 BOTTLETABLET10003
50228-379-30Ezetimibe30 in 1 BOTTLETABLET303
50228-379-90Ezetimibe90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-379-05EA - Each50228-3791bcf5822-3277-4f54-a98e-d0cd79d6e8c712021-04-08
50228-379-30EA - Each50228-3793fc4917a-74d2-43b2-9acb-d990a53e1d4512021-04-08
50228-379-90EA - Each50228-37932e8ce7b-c631-495d-86b9-b1be213d25bc12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-379EZETIMIBE TABLET [SCIEGEN PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 4 package rows20240614_11de499b-ad8a-46a6-9021-c8eba72ae414.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN11de499b-ad8a-46a6-9021-c8eba72ae4143
349556ezetimibe 10 MG Oral TabletSCD11de499b-ad8a-46a6-9021-c8eba72ae4143

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-379-0550228037905500 TABLET in 1 BOTTLE (50228-379-05) 500 tablet2020-10-230000-00-00NoNoCurrent
50228-379-10502280379101000 TABLET in 1 BOTTLE (50228-379-10) 1000 tablet2020-10-230000-00-00NoNoCurrent
50228-379-305022803793030 TABLET in 1 BOTTLE (50228-379-30) 30 tablet2020-10-230000-00-00NoNoCurrent
50228-379-905022803799090 TABLET in 1 BOTTLE (50228-379-90) 90 tablet2020-10-230000-00-00NoNoCurrent