FDA.reportPublic FDA data

Ezetimibe

Product NDC
60687-373
11-digit product format
606870373
Labeler code
60687
Product ID
60687-373_41245086-1b60-b4a1-e063-6394a90a2d0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA209234
Marketing category
ANDA
Marketing start
2018-09-06
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
60687-373-11Ezetimibe1 in 1 BLISTER PACKTABLET17
60687-373-21Ezetimibe30 in 1 BOX, UNIT-DOSETABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-373-11EA - Each60687-37320459f4f-79f2-4945-9125-94a0615d68b412018-09-05
60687-373-21EA - Each60687-373a733cc1c-6caf-4d9b-aa06-d6f71ef01f1c12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-373EZETIMIBE TABLET [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20240913_0e9a9eda-1b2a-4475-8483-0f410a17c524.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN0e9a9eda-1b2a-4475-8483-0f410a17c5247
349556ezetimibe 10 MG Oral TabletSCD0e9a9eda-1b2a-4475-8483-0f410a17c5247

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-373-11606870373111 in 1 BLISTER PACKHistorical
60687-373-216068703732130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-373-21) / 1 TABLET in 1 BLISTER PACK (60687-373-11) 30 blister pack2018-09-060000-00-00NoNoCurrent