Ezetimibe

Product NDC
50090-6631
11-digit product format
500906631
Labeler code
50090
Product ID
50090-6631_f5276887-efe2-42ff-94df-5b6a6e240d31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
EOR26LQQ24EZETIMIBE163222-33-1EZETIMIBE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6631-05009066310090 TABLET in 1 BOTTLE (50090-6631-0) 90 tablet2023-08-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
EzetimibeA-S Medication Solutions2024-05-06Human Prescription Drug Label4