FDA.reportPublic FDA data

Ezetimibe

Product NDC
0591-3713
11-digit product format
005913713
Labeler code
0591
Product ID
0591-3713_24aaf5ca-08e0-4db8-9734-cf2a606f8e57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA200831
Marketing category
ANDA
Marketing start
2017-06-12
Marketing end
2026-07-31
Substance
EZETIMIBE
Active strength
10 mg/1
Pharmacologic classes
Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ezetimibe

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
0591-3713-05Ezetimibe500 in 1 BOTTLETABLET50011
0591-3713-19Ezetimibe90 in 1 BOTTLETABLET9011
0591-3713-30Ezetimibe30 in 1 BOTTLETABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3713-05EA - Each0591-37130232fbc4-ac9e-48de-b61d-dd8c532389a012017-10-13
0591-3713-19EA - Each0591-3713ad9e0789-a362-491b-b740-0767a88b377b12017-07-07
0591-3713-30EA - Each0591-371352c722aa-18fd-48d3-9486-a1377c9f45d312017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3713EZETIMIBE TABLET [ACTAVIS PHARMA, INC.]10Current NDC, Legacy NDC, 3 package rows20240601_f26e7a4e-b3d9-4cf8-baf0-7423d46cd8ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSNf26e7a4e-b3d9-4cf8-baf0-7423d46cd8ba11
349556ezetimibe 10 MG Oral TabletSCDf26e7a4e-b3d9-4cf8-baf0-7423d46cd8ba11
349556ezetimibe 10 MG Oral TabletPSN11828685-dc27-42d8-a6ff-f110018207d15
349556ezetimibe 10 MG Oral TabletSCD11828685-dc27-42d8-a6ff-f110018207d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3713-0500591371305500 TABLET in 1 BOTTLE (0591-3713-05) 500 tablet2017-06-122026-07-31NoNoCurrent
0591-3713-190059137131990 TABLET in 1 BOTTLE (0591-3713-19) 90 tablet2017-06-122026-07-31NoNoCurrent
0591-3713-300059137133030 TABLET in 1 BOTTLE (0591-3713-30) 30 tablet2017-06-122026-07-31NoNoCurrent