"57297-772-02" National Drug Code (NDC)

Amlodipine, Valsartan And Hydrochlorothiazide 500 TABLET, FILM COATED in 1 BOTTLE (57297-772-02)
(LUPIN LIMITED)

NDC Code57297-772-02
Package Description500 TABLET, FILM COATED in 1 BOTTLE (57297-772-02)
Product NDC57297-772
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAmlodipine, Valsartan And Hydrochlorothiazide
Non-Proprietary NameAmlodipine, Valsartan And Hydrochlorothiazide
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20150603
Marketing Category NameANDA
Application NumberANDA200797
ManufacturerLUPIN LIMITED
Substance NameAMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE
Strength10; 160; 12.5
Strength Unitmg/1; mg/1; mg/1
Pharmacy ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]

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