FDA.reportPublic FDA data

Ezetimibe

Product NDC
0781-5690
11-digit product format
007815690
Labeler code
0781
Product ID
0781-5690_c5e4a665-e54b-4452-bbc7-0a75b633ea94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA203931
Marketing category
ANDA
Marketing start
2017-06-12
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
0781-5690-05Ezetimibe500 in 1 BOTTLETABLET5006
0781-5690-31Ezetimibe30 in 1 BOTTLETABLET306
0781-5690-92Ezetimibe90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5690-05EA - Each0781-5690a20df6b3-9452-438d-94cd-952082a4731812017-07-07
0781-5690-31EA - Each0781-569061ecf5d1-4c52-46f4-bb60-12788c92a8f412017-07-07
0781-5690-92EA - Each0781-56907a3ae5e9-9d5e-49cb-9b48-314894661e7812017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5690EZETIMIBE TABLET [SANDOZ INC]6Current NDC, Legacy NDC, 3 package rows20240807_ebcb6655-fd60-4099-8099-be911c5b32ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSNebcb6655-fd60-4099-8099-be911c5b32ae6
349556ezetimibe 10 MG Oral TabletSCDebcb6655-fd60-4099-8099-be911c5b32ae6
349556ezetimibe 10 MG Oral TabletPSN03609879-bad2-4e75-83fe-1e1a2fd300c34
349556ezetimibe 10 MG Oral TabletSCD03609879-bad2-4e75-83fe-1e1a2fd300c34
349556ezetimibe 10 MG Oral TabletPSN5cbd9bce-e02d-440f-95d5-4eb958d2f4f33
349556ezetimibe 10 MG Oral TabletSCD5cbd9bce-e02d-440f-95d5-4eb958d2f4f33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-5690-0500781569005500 TABLET in 1 BOTTLE (0781-5690-05) 500 tablet2017-06-120000-00-00NoNoCurrent
0781-5690-310078156903130 TABLET in 1 BOTTLE (0781-5690-31) 30 tablet2017-06-120000-00-00NoNoCurrent
0781-5690-920078156909290 TABLET in 1 BOTTLE (0781-5690-92) 90 tablet2017-06-120000-00-00NoNoCurrent