Ezetimibe and Simvastatin

Product NDC
62559-701
11-digit product format
625590701
Labeler code
62559
Product ID
62559-701_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
62559-701-30EA - Each62559-701ba0fbf7e-4052-4e81-8a30-ddec1be5f7e512018-10-11
62559-701-90EA - Each62559-701746d7866-c633-46d4-8a9c-a3e0f3df79ff12018-10-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-701-306255907013030 TABLET in 1 BOTTLE (62559-701-30) 30 tablet2018-09-240000-00-00NoNoCurrent
62559-701-906255907019090 TABLET in 1 BOTTLE (62559-701-90) 90 tablet2018-09-240000-00-00NoNoCurrent