FDA.reportPublic FDA data

Ezetimibe

Product NDC
51660-200
11-digit product format
516600200
Labeler code
51660
Product ID
51660-200_12e7e79e-85d0-0c5d-e063-6394a90a8b78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA207311
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
51660-200-05Ezetimibe500 in 1 BOTTLETABLET5007
51660-200-30Ezetimibe30 in 1 BOTTLETABLET307
51660-200-90Ezetimibe90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-200-05EA - Each51660-200e2d408fc-34f2-4ee7-a6a8-f2e9d5dd4d2312017-07-07
51660-200-30EA - Each51660-2004860f813-626d-489c-b99f-767cb44ef17212017-07-07
51660-200-90EA - Each51660-20011628327-4d84-4ba2-a41a-4418d843513612017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-200EZETIMIBE TABLET [OHM LABORATORIES INC.]7Current NDC, Legacy NDC, 3 package rows20240307_5b3842f6-c80a-47b8-8a82-b69e465b05f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN4a78aa8d-1fe0-4df0-a15b-2350c15aead17
349556ezetimibe 10 MG Oral TabletPSN5b3842f6-c80a-47b8-8a82-b69e465b05f77
349556ezetimibe 10 MG Oral TabletSCD4a78aa8d-1fe0-4df0-a15b-2350c15aead17
349556ezetimibe 10 MG Oral TabletSCD5b3842f6-c80a-47b8-8a82-b69e465b05f77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-200-0551660020005500 TABLET in 1 BOTTLE (51660-200-05) 500 tablet2017-06-120000-00-00NoNoCurrent
51660-200-305166002003030 TABLET in 1 BOTTLE (51660-200-30) 30 tablet2017-06-120000-00-00NoNoCurrent
51660-200-905166002009090 TABLET in 1 BOTTLE (51660-200-90) 90 tablet2017-06-120000-00-00NoNoCurrent