Ezetimibe

Product NDC
50268-298
11-digit product format
502680298
Labeler code
50268
Product ID
50268-298_484a0aba-8404-df2e-e063-6394a90aea0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA208803
Marketing category
ANDA
Marketing start
2017-07-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ezetimibe
Listing expiration
2027-12-31

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
50268-298-11Ezetimibe1 in 1 BLISTER PACKTABLET16
50268-298-12Ezetimibe20 in 1 BOX, UNIT-DOSETABLET206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-298-11EA - Each50268-2980a221fee-3d46-4bdb-9c64-1d251be7555012018-09-05
50268-298-12EA - Each50268-298e2e209df-2557-42ab-bf15-0a4925b913fa12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-298EZETIMIBE TABLET [AVPAK]4Current NDC, Legacy NDC, 2 package rows20240110_6fcbfbd9-6e09-8224-e053-2a91aa0a8226.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN6fcbfbd9-6e09-8224-e053-2a91aa0a82266
349556ezetimibe 10 MG Oral TabletSCD6fcbfbd9-6e09-8224-e053-2a91aa0a82266

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-298-11502680298111 in 1 BLISTER PACKHistorical
50268-298-125026802981220 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-298-12) / 1 TABLET in 1 BLISTER PACK (50268-298-11) 20 blister pack2017-07-020000-00-00NoNoCurrent