Ezetimibe

Product NDC
50090-3422
11-digit product format
500903422
Labeler code
50090
Product ID
50090-3422_a1915b61-123e-406c-ba03-a6ad459829d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209838
Marketing category
ANDA
Marketing start
2017-08-25
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
50090-3422-0Ezetimibe30 in 1 BOTTLETABLET309
50090-3422-1Ezetimibe90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3422-0EA - Each50090-34225b69c374-bd17-4b9b-8a49-a7a0b7635a4412019-05-02
50090-3422-1EA - Each50090-3422413c97f7-ed5b-483b-8183-131d398cf92b12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3422EZETIMIBE TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20241003_63ecbbf1-a6de-493f-9710-812ff45cb4d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN63ecbbf1-a6de-493f-9710-812ff45cb4d39
349556ezetimibe 10 MG Oral TabletSCD63ecbbf1-a6de-493f-9710-812ff45cb4d39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-3422-05009034220030 TABLET in 1 BOTTLE (50090-3422-0) 30 tablet2018-03-28NoNoHistorical
50090-3422-15009034220190 TABLET in 1 BOTTLE (50090-3422-1) 90 tablet2018-04-03NoNoHistorical