Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide

Product NDC
70518-1648
11-digit product format
705181648
Labeler code
70518
Product ID
70518-1648_e5bcf9ee-e1b7-bc16-e053-2995a90ab299
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA200175
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-11-07
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-1648-02021-02-19C16284748780-1ba0f9c33-524f-a910-e053-dadaa90a0b85663c1219-6064-4dab-bd47-49b79e41880d
70518-1648-02021-01-29C16284748780-1ba0f9c33-524f-a910-e053-dadaa90a0b85663c1219-6064-4dab-bd47-49b79e41880d

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1648-07051816480030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1648-0) 2018-11-070000-00-00NoNoCurrent