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Spironolactone - 0378-0437-01 - (spironolactone)

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Drug Information of Spironolactone

Product NDC: 0378-0437
Proprietary Name: Spironolactone
Non Proprietary Name: spironolactone
Active Ingredient(s): 100    mg/1 & nbsp;   spironolactone
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Spironolactone

Product NDC: 0378-0437
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA040424
Marketing Category: ANDA
Start Marketing Date: 20110519

Package Information of Spironolactone

Package NDC: 0378-0437-01
Package Description: 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0437-01)

NDC Information of Spironolactone

NDC Code 0378-0437-01
Proprietary Name Spironolactone
Package Description 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0437-01)
Product NDC 0378-0437
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name spironolactone
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20110519
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name SPIRONOLACTONE
Strength Number 100
Strength Unit mg/1
Pharmaceutical Classes Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]

Complete Information of Spironolactone


General Information