Ezetimibe

Product NDC
71205-145
11-digit product format
712050145
Labeler code
71205
Product ID
71205-145_4d2909bd-31fd-4ddc-99b5-2fc99b35f5d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
71205-145-30Ezetimibe30 in 1 BOTTLETABLET303
71205-145-60Ezetimibe60 in 1 BOTTLETABLET603
71205-145-90Ezetimibe90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-145-30EA - Each71205-1457cf96db5-edc9-41c3-b221-28184f5385d912019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-145EZETIMIBE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191022_5cbd9bce-e02d-440f-95d5-4eb958d2f4f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71205-145-307120501453030 TABLET in 1 BOTTLE (71205-145-30) 30 tablet2018-11-010000-00-00NoNoCurrent
71205-145-607120501456060 TABLET in 1 BOTTLE (71205-145-60) 60 tablet2018-11-010000-00-00NoNoCurrent
71205-145-907120501459090 TABLET in 1 BOTTLE (71205-145-90) 90 tablet2018-11-010000-00-00NoNoCurrent