FDA.reportPublic FDA data

Ezetimibe

Product NDC
50090-3087
11-digit product format
500903087
Labeler code
50090
Product ID
50090-3087_49b36805-9ed1-415b-9c63-f78a067150a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208803
Marketing category
ANDA
Marketing start
2017-06-12
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
50090-3087-02023-01-30C16284748780-1f386c64a-46a1-0266-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
50090-3087-0Ezetimibe30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3087-0EA - Each50090-30873f3d773c-26c8-4b2c-9a8a-7c0a3aaa50c512019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3087EZETIMIBE TABLET [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20190203_6713ea4e-8d4a-4787-ad5f-df44983b60cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN6713ea4e-8d4a-4787-ad5f-df44983b60cf2
349556ezetimibe 10 MG Oral TabletSCD6713ea4e-8d4a-4787-ad5f-df44983b60cf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3087-05009030870030 TABLET in 1 BOTTLE (50090-3087-0) 30 tablet2017-07-060000-00-00NoNoCurrent