FDA.reportPublic FDA data

Ezetimibe

Product NDC
16714-813
11-digit product format
167140813
Labeler code
16714
Product ID
16714-813_ce024e9f-19a7-4819-8069-60121c4cf6c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA209838
Marketing category
ANDA
Marketing start
2021-02-01
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
16714-813-01Ezetimibe30 in 1 BOTTLETABLET306
16714-813-02Ezetimibe90 in 1 BOTTLETABLET906
16714-813-03Ezetimibe500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-813-01EA - Each16714-8130713e164-a726-4f9e-a8a8-a1fbb32544b612021-03-02
16714-813-02EA - Each16714-813ba3e7215-351e-44ac-be18-5e2f58476a4812021-03-02
16714-813-03EA - Each16714-813d4422a3a-aa40-46a0-afe7-9cb0ed73426612021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-813EZETIMIBE TABLET [NORTHSTAR RX LLC]6Current NDC, Legacy NDC, 3 package rows20250316_5f5644a9-e019-4e5d-ab6f-3d30b1024c5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN5f5644a9-e019-4e5d-ab6f-3d30b1024c5a6
349556ezetimibe 10 MG Oral TabletSCD5f5644a9-e019-4e5d-ab6f-3d30b1024c5a6
349556ezetimibe 10 MG Oral TabletPSNa1cc2018-72a3-48bc-90de-c460f224cf5a4
349556ezetimibe 10 MG Oral TabletSCDa1cc2018-72a3-48bc-90de-c460f224cf5a4
349556ezetimibe 10 MG Oral TabletPSN090776cf-f211-49a3-a993-ff5d707311f21
349556ezetimibe 10 MG Oral TabletSCD090776cf-f211-49a3-a993-ff5d707311f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-813-011671408130130 TABLET in 1 BOTTLE (16714-813-01) 30 tablet2021-02-010000-00-00NoNoCurrent
16714-813-021671408130290 TABLET in 1 BOTTLE (16714-813-02) 90 tablet2021-02-010000-00-00NoNoCurrent
16714-813-0316714081303500 TABLET in 1 BOTTLE (16714-813-03) 500 tablet2021-02-010000-00-00NoNoCurrent