Ezetimibe

Product NDC
67877-490
11-digit product format
678770490
Labeler code
67877
Product ID
67877-490_878751ea-5bea-42ef-8f56-2b15a683c7ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA209234
Marketing category
ANDA
Marketing start
2017-12-23
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
67877-490-01Ezetimibe100 in 1 BOTTLETABLET10012
67877-490-05Ezetimibe500 in 1 BOTTLETABLET50012
67877-490-30Ezetimibe30 in 1 BOTTLETABLET3012
67877-490-55Ezetimibe5000 in 1 BOTTLETABLET500012
67877-490-90Ezetimibe90 in 1 BOTTLETABLET9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-490-05EA - Each67877-490845138f6-d43a-4f27-ba82-111157affaa612018-02-20
67877-490-30EA - Each67877-4901fad7d50-0c78-4142-ad59-7cf101f1c60c12018-02-20
67877-490-90EA - Each67877-4904f2bed83-8cd3-4bda-a63e-697cf12a913012018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-490EZETIMIBE TABLET [ASCEND LABORATORIES, LLC]11Current NDC, Legacy NDC, 5 package rows20240510_206d702c-b09a-4555-972b-6555d6d6d6e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN206d702c-b09a-4555-972b-6555d6d6d6e612
349556ezetimibe 10 MG Oral TabletSCD206d702c-b09a-4555-972b-6555d6d6d6e612
349556ezetimibe 10 MG Oral TabletPSN0e9a9eda-1b2a-4475-8483-0f410a17c5247
349556ezetimibe 10 MG Oral TabletPSN9a04678f-e961-45aa-b3bb-e38e66856edc7
349556ezetimibe 10 MG Oral TabletPSNe257ed7f-5015-4f1d-93f4-5adf5797643d7
349556ezetimibe 10 MG Oral TabletSCD0e9a9eda-1b2a-4475-8483-0f410a17c5247
349556ezetimibe 10 MG Oral TabletSCD9a04678f-e961-45aa-b3bb-e38e66856edc7
349556ezetimibe 10 MG Oral TabletSCDe257ed7f-5015-4f1d-93f4-5adf5797643d7
349556ezetimibe 10 MG Oral TabletPSNc92292f5-5444-4247-927e-db7bf68161096
349556ezetimibe 10 MG Oral TabletSCDc92292f5-5444-4247-927e-db7bf68161096
349556ezetimibe 10 MG Oral TabletPSNfbbe54c3-59a1-436c-aba8-188ba7ca70e03
349556ezetimibe 10 MG Oral TabletSCDfbbe54c3-59a1-436c-aba8-188ba7ca70e03
349556ezetimibe 10 MG Oral TabletPSNdd8a09cb-f014-4650-9da2-4ad1581c97412
349556ezetimibe 10 MG Oral TabletPSNb57dcdef-894c-4801-e053-2a95a90a72392
349556ezetimibe 10 MG Oral TabletSCDdd8a09cb-f014-4650-9da2-4ad1581c97412
349556ezetimibe 10 MG Oral TabletSCDb57dcdef-894c-4801-e053-2a95a90a72392
349556ezetimibe 10 MG Oral TabletPSN1e18d6b2-b09c-4a16-e063-6294a90a78391
349556ezetimibe 10 MG Oral TabletSCD1e18d6b2-b09c-4a16-e063-6294a90a78391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-490-0167877049001100 TABLET in 1 BOTTLE (67877-490-01) 100 tablet2017-12-230000-00-00NoNoCurrent
67877-490-0567877049005500 TABLET in 1 BOTTLE (67877-490-05) 500 tablet2017-12-230000-00-00NoNoCurrent
67877-490-306787704903030 TABLET in 1 BOTTLE (67877-490-30) 30 tablet2017-12-230000-00-00NoNoCurrent
67877-490-55678770490555000 TABLET in 1 BOTTLE (67877-490-55) 5000 tablet2017-12-230000-00-00NoNoCurrent
67877-490-906787704909090 TABLET in 1 BOTTLE (67877-490-90) 90 tablet2017-12-230000-00-00NoNoCurrent