VYTORIN

Product NDC
55289-280
11-digit product format
552890280
Labeler code
55289
Product ID
55289-280_d9a601bf-fa26-b6ba-e053-2995a90a42a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ezetimibe and simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA021687
Marketing category
NDA
Marketing start
2004-07-23
Marketing end
0000-00-00
Substance
EZETIMIBE; SIMVASTATIN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-280-30EA - Each55289-28007f46d43-dbfa-464a-9982-0ffa9c538ff212012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-280-305528902803030 TABLET in 1 BOTTLE, PLASTIC (55289-280-30) 30 tablet2011-11-010000-00-00NoNoCurrent