FDA.reportPublic FDA data

ezetimibe

Product NDC
68382-773
11-digit product format
683820773
Labeler code
68382
Product ID
68382-773_ebb60f24-14be-4be0-b5e2-31e695eae876
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA204331
Marketing category
ANDA
Marketing start
2017-08-09
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
68382-773-01ezetimibe100 in 1 BOTTLETABLET1006
68382-773-05ezetimibe500 in 1 BOTTLETABLET5006
68382-773-06ezetimibe30 in 1 BOTTLETABLET306
68382-773-10ezetimibe1000 in 1 BOTTLETABLET10006
68382-773-16ezetimibe90 in 1 BOTTLETABLET906
68382-773-30ezetimibe10 in 1 BLISTER PACKTABLET106
68382-773-77ezetimibe10 in 1 CARTONTABLET106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-773-05EA - Each68382-7734e473476-0aab-418f-b254-bf755af276ff12018-04-19
68382-773-06EA - Each68382-7736710b7a0-01f6-4ddf-a21e-ea2732ff6d5112018-04-19
68382-773-16EA - Each68382-7737dc770c6-8fcb-4b9f-a6b3-a8980b3dfcfb12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-773EZETIMIBE TABLET [ZYDUS PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 7 package rows20240302_f852b12f-e25f-415b-b1e2-58955d609507.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSNf852b12f-e25f-415b-b1e2-58955d6095076
349556ezetimibe 10 MG Oral TabletSCDf852b12f-e25f-415b-b1e2-58955d6095076

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-773-0168382077301100 TABLET in 1 BOTTLE (68382-773-01) 100 tablet2017-08-090000-00-00NoNoCurrent
68382-773-0568382077305500 TABLET in 1 BOTTLE (68382-773-05) 500 tablet2017-08-090000-00-00NoNoCurrent
68382-773-066838207730630 TABLET in 1 BOTTLE (68382-773-06) 30 tablet2017-08-090000-00-00NoNoCurrent
68382-773-10683820773101000 TABLET in 1 BOTTLE (68382-773-10) 1000 tablet2017-08-090000-00-00NoNoCurrent
68382-773-166838207731690 TABLET in 1 BOTTLE (68382-773-16) 90 tablet2017-08-090000-00-00NoNoCurrent
68382-773-306838207733010 in 1 BLISTER PACKHistorical
68382-773-776838207737710 BLISTER PACK in 1 CARTON (68382-773-77) / 10 TABLET in 1 BLISTER PACK (68382-773-30) 10 blister pack2017-08-090000-00-00NoNoCurrent