FDA.reportPublic FDA data

Ezetimibe

Product NDC
33342-373
11-digit product format
333420373
Labeler code
33342
Product ID
33342-373_ebe3fa4e-82c4-4a9a-9aec-f64019391f4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA211159
Marketing category
ANDA
Marketing start
2024-04-29
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
33342-373-07Ezetimibe30 in 1 BOTTLETABLET301
33342-373-10Ezetimibe90 in 1 BOTTLETABLET901
33342-373-15Ezetimibe500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-373EZETIMIBE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 3 package rows20240515_ebe3fa4e-82c4-4a9a-9aec-f64019391f4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSNebe3fa4e-82c4-4a9a-9aec-f64019391f4e1
349556ezetimibe 10 MG Oral TabletSCDebe3fa4e-82c4-4a9a-9aec-f64019391f4e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-373-073334203730730 TABLET in 1 BOTTLE (33342-373-07) 30 tablet2024-04-29NoNoHistorical
33342-373-103334203731090 TABLET in 1 BOTTLE (33342-373-10) 90 tablet2024-04-29NoNoHistorical
33342-373-1533342037315500 TABLET in 1 BOTTLE (33342-373-15) 500 tablet2024-04-29NoNoHistorical