olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

Product NDC
72162-1514
11-digit product format
721621514
Labeler code
72162
Product ID
72162-1514_5785cd86-1317-465c-a6ff-45f65cb8c8f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206137
Marketing category
ANDA
Marketing start
2016-10-26
Substance
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength
5; 12.5; 20 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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
864V2Q084HAMLODIPINE BESYLATE111470-99-6AMLODIPINE BESYLATE
0J48LPH2THHYDROCHLOROTHIAZIDE58-93-5HYDROCHLOROTHIAZIDE
6M97XTV3HDOLMESARTAN MEDOXOMIL144689-63-4OLMESARTAN MEDOXOMIL

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1514-37216215140330 TABLET, FILM COATED in 1 BOTTLE (72162-1514-3) 2023-10-06NoNoHistorical
72162-1514-97216215140990 TABLET, FILM COATED in 1 BOTTLE (72162-1514-9) 2023-10-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideBryant Ranch Prepack2024-02-07HUMAN PRESCRIPTION DRUG LABEL101