Ezetimibe and Simvastatin

Product NDC
62559-703
11-digit product format
625590703
Labeler code
62559
Product ID
62559-703_61c89be9-44b0-42ca-bedd-1c0b65662757
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA208831
Marketing category
ANDA
Marketing start
2018-09-24
Marketing end
2023-03-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-703-30EA - Each62559-703f9770913-ea1f-451e-99df-3c61668a79cb12018-10-11
62559-703-90EA - Each62559-703912ee42b-e926-424d-9c9d-4188429d61e112018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-703-306255907033030 TABLET in 1 BOTTLE (62559-703-30) 30 tablet2018-09-240000-00-00NoNoCurrent
62559-703-906255907039090 TABLET in 1 BOTTLE (62559-703-90) 90 tablet2018-09-240000-00-00NoNoCurrent