FDA.reportPublic FDA data

Ezetimibe

Product NDC
59651-052
11-digit product format
596510052
Labeler code
59651
Product ID
59651-052_60081062-9f4b-4cf5-9c24-02b5a0b7f792
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
59651-052-05Ezetimibe500 in 1 BOTTLETABLET50010
59651-052-30Ezetimibe30 in 1 BOTTLETABLET3010
59651-052-90Ezetimibe90 in 1 BOTTLETABLET9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-052-05EA - Each59651-052edcb1ad6-bb41-4c3e-8a5d-ea68e62e4eb212017-11-06
59651-052-30EA - Each59651-052519c46dd-14cb-4c68-ab96-a2fb8a4578e812017-11-06
59651-052-90EA - Each59651-0522395b213-34b6-437d-9478-f3b84a5815b012017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-052EZETIMIBE TABLET [AUROBINDO PHARMA LIMITED]10Current NDC, Legacy NDC, 3 package rows20250316_726b1e63-437a-4b3b-b773-3ac47a5c0f38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN3a80b668-51cd-42be-8497-8712b0508422103
349556ezetimibe 10 MG Oral TabletSCD3a80b668-51cd-42be-8497-8712b0508422103
349556ezetimibe 10 MG Oral TabletPSN726b1e63-437a-4b3b-b773-3ac47a5c0f3810
349556ezetimibe 10 MG Oral TabletSCD726b1e63-437a-4b3b-b773-3ac47a5c0f3810
349556ezetimibe 10 MG Oral TabletPSN63ecbbf1-a6de-493f-9710-812ff45cb4d39
349556ezetimibe 10 MG Oral TabletSCD63ecbbf1-a6de-493f-9710-812ff45cb4d39
349556ezetimibe 10 MG Oral TabletPSN57d19491-cba1-4720-b69d-4815744592011
349556ezetimibe 10 MG Oral TabletPSN8b128e52-5d0d-4536-aa1f-be192d0989ad1
349556ezetimibe 10 MG Oral TabletSCD57d19491-cba1-4720-b69d-4815744592011
349556ezetimibe 10 MG Oral TabletSCD8b128e52-5d0d-4536-aa1f-be192d0989ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-052-0559651005205500 TABLET in 1 BOTTLE (59651-052-05) 500 tablet2017-08-250000-00-00NoNoCurrent
59651-052-305965100523030 TABLET in 1 BOTTLE (59651-052-30) 30 tablet2017-08-250000-00-00NoNoCurrent
59651-052-905965100529090 TABLET in 1 BOTTLE (59651-052-90) 90 tablet2017-08-250000-00-00NoNoCurrent