"54868-6457-0" National Drug Code (NDC)

Irbesartan And Hydrochlorothiazide 30 TABLET, FILM COATED in 1 BOTTLE (54868-6457-0)
(Physicians Total Care, Inc.)

NDC Code54868-6457-0
Package Description30 TABLET, FILM COATED in 1 BOTTLE (54868-6457-0)
Product NDC54868-6457
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIrbesartan And Hydrochlorothiazide
Non-Proprietary NameIrbesartan And Hydrochlorothiazide
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20120927
Marketing Category NameANDA
Application NumberANDA202414
ManufacturerPhysicians Total Care, Inc.
Substance NameIRBESARTAN; HYDROCHLOROTHIAZIDE
Strength150; 12.5
Strength Unitmg/1; mg/1
Pharmacy ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]

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