"0378-0403-01" National Drug Code (NDC)

Spironolactone And Hydrochlorothiazide 100 TABLET in 1 BOTTLE, PLASTIC (0378-0403-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-0403-01
Package Description100 TABLET in 1 BOTTLE, PLASTIC (0378-0403-01)
Product NDC0378-0403
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSpironolactone And Hydrochlorothiazide
Non-Proprietary NameSpironolactone And Hydrochlorothiazide
Dosage FormTABLET
UsageORAL
Start Marketing Date19790803
Marketing Category NameANDA
Application NumberANDA086513
ManufacturerMylan Pharmaceuticals Inc.
Substance NameHYDROCHLOROTHIAZIDE; SPIRONOLACTONE
Strength25; 25
Strength Unitmg/1; mg/1
Pharmacy ClassesAldosterone Antagonist [EPC], Aldosterone Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]

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