"65862-838-05" National Drug Code (NDC)

NDC Code	65862-838-05
Package Description	500 TABLET, FILM COATED in 1 BOTTLE (65862-838-05)
Product NDC	65862-838
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Amlodipine, Valsartan And Hydrochlorothiazide
Non-Proprietary Name	Amlodipine, Valsartan And Hydrochlorothiazide
Dosage Form	TABLET, FILM COATED
Usage	ORAL
Start Marketing Date	20171219
Marketing Category Name	ANDA
Application Number	ANDA206180
Manufacturer	Aurobindo Pharma Limited
Substance Name	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Strength	10; 25; 320
Strength Unit	mg/1; mg/1; mg/1
Pharmacy 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]