Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide

Product NDC
57664-799
11-digit product format
576640799
Labeler code
57664
Product ID
57664-799_e97e6623-9454-4d2f-8cbc-d84db5f0b5ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA200175
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-10-26
Marketing end
2024-06-30
Substance
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength
5 mg/1; mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
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
57664-799-83EA - Each57664-799e369e0fe-7344-4200-84b7-632f0092a3bb12016-11-08
57664-799-99EA - Each57664-7994029f384-9c2d-4284-a6cd-353ce66cd48612016-11-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57664-799-835766407998330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-799-83) 2016-10-260000-00-00NoNoCurrent
57664-799-995766407999990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-799-99) 2016-10-260000-00-00NoNoCurrent