FDA.reportPublic FDA data

Ezetimibe

Product NDC
50090-3657
11-digit product format
500903657
Labeler code
50090
Product ID
50090-3657_ec0339aa-f360-45c5-82f8-3f60df9c2cf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3657-02023-02-07C16284748780-1f386c649-d5fa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS. EZETIMIBE tablets, for oral use. Initial U.S. Approval: 2002
50090-3657-12023-02-07C16284748780-1f386c649-d5fa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS. EZETIMIBE tablets, for oral use. Initial U.S. Approval: 2002
50090-3657-02023-01-30C16284748780-1f386c649-d5fa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS. EZETIMIBE tablets, for oral use. Initial U.S. Approval: 2002
50090-3657-12023-01-30C16284748780-1f386c649-d5fa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS. EZETIMIBE tablets, for oral use. Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3657-0Ezetimibe30 in 1 BOTTLE, PLASTICTABLET307
50090-3657-1Ezetimibe90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3657-0EA - Each50090-3657363b8901-cab8-402f-9a34-1cc6a598f89112021-10-08
50090-3657-1EA - Each50090-3657ba175e5c-8798-4ee5-ae58-8e41f3b18fc912021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3657EZETIMIBE TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20230922_9a04678f-e961-45aa-b3bb-e38e66856edc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN9a04678f-e961-45aa-b3bb-e38e66856edc7
349556ezetimibe 10 MG Oral TabletSCD9a04678f-e961-45aa-b3bb-e38e66856edc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3657-05009036570030 TABLET in 1 BOTTLE, PLASTIC (50090-3657-0) 30 tablet2017-12-230000-00-00NoNoCurrent
50090-3657-15009036570190 TABLET in 1 BOTTLE (50090-3657-1) 90 tablet2018-10-110000-00-00NoNoCurrent