Ezetimibe

Product NDC
0615-8300
11-digit product format
006158300
Labeler code
0615
Product ID
0615-8300_0318598c-29b9-4e48-a29b-c22266595eb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA209838
Marketing category
ANDA
Marketing start
2017-08-25
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8300EZETIMIBE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]3Legacy NDC20250330_f30c3cb1-fb91-4f69-b181-bfb4238635af.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8300-390061583003930 TABLET in 1 BLISTER PACK (0615-8300-39) 30 tablet2019-07-030000-00-00NoNoCurrent