FDA.reportPublic FDA data

Ezetimibe

Product NDC
69238-1154
11-digit product format
692381154
Labeler code
69238
Product ID
69238-1154_edb9906a-4007-40ff-a3dc-3083e50545ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208803
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
69238-1154-1Ezetimibe1000 in 1 BOTTLETABLET100014
69238-1154-3Ezetimibe30 in 1 BOTTLETABLET3014
69238-1154-5Ezetimibe500 in 1 BOTTLETABLET50014
69238-1154-9Ezetimibe90 in 1 BOTTLETABLET9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1154-3EA - Each69238-1154c085ae9c-14b1-431e-8feb-02430c85003f12017-07-07
69238-1154-5EA - Each69238-11543880b46a-8c4f-43aa-b202-e2d521268ae312017-07-07
69238-1154-9EA - Each69238-1154b92666b0-31d0-4f26-ac13-b0a34533e2df12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1154EZETIMIBE TABLET [AMNEAL PHARMACEUTICALS NY LLC]14Current NDC, Legacy NDC, 4 package rows20250402_3fadf4e9-017d-4ccd-91dc-a89b981eb138.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN3fadf4e9-017d-4ccd-91dc-a89b981eb13814
349556ezetimibe 10 MG Oral TabletSCD3fadf4e9-017d-4ccd-91dc-a89b981eb13814
349556ezetimibe 10 MG Oral TabletPSN6fcbfbd9-6e09-8224-e053-2a91aa0a82266
349556ezetimibe 10 MG Oral TabletPSNd6b4fd12-9954-42ba-b42a-56f3747c47ff6
349556ezetimibe 10 MG Oral TabletSCD6fcbfbd9-6e09-8224-e053-2a91aa0a82266
349556ezetimibe 10 MG Oral TabletSCDd6b4fd12-9954-42ba-b42a-56f3747c47ff6
349556ezetimibe 10 MG Oral TabletPSN6713ea4e-8d4a-4787-ad5f-df44983b60cf2
349556ezetimibe 10 MG Oral TabletSCD6713ea4e-8d4a-4787-ad5f-df44983b60cf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1154-1692381154011000 TABLET in 1 BOTTLE (69238-1154-1) 1000 tablet2017-06-120000-00-00NoNoCurrent
69238-1154-36923811540330 TABLET in 1 BOTTLE (69238-1154-3) 30 tablet2017-06-120000-00-00NoNoCurrent
69238-1154-569238115405500 TABLET in 1 BOTTLE (69238-1154-5) 500 tablet2017-06-120000-00-00NoNoCurrent
69238-1154-96923811540990 TABLET in 1 BOTTLE (69238-1154-9) 90 tablet2017-06-120000-00-00NoNoCurrent