Isosorbide - 52125-610-20 - (Isosorbide mononitrate)

Alphabetical Index


Drug Information of Isosorbide

Product NDC: 52125-610
Proprietary Name: Isosorbide
Non Proprietary Name: Isosorbide mononitrate
Active Ingredient(s): 60    mg/1 & nbsp;   Isosorbide mononitrate
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED, EXTENDED RELEASE
Coding System: National Drug Codes(NDC)

Labeler Information of Isosorbide

Product NDC: 52125-610
Labeler Name: REMEDYREPACK INC.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA076813
Marketing Category: ANDA
Start Marketing Date: 20130529

Package Information of Isosorbide

Package NDC: 52125-610-20
Package Description: 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 VIAL (52125-610-20)

NDC Information of Isosorbide

NDC Code 52125-610-20
Proprietary Name Isosorbide
Package Description 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 VIAL (52125-610-20)
Product NDC 52125-610
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Isosorbide mononitrate
Dosage Form Name TABLET, FILM COATED, EXTENDED RELEASE
Route Name ORAL
Start Marketing Date 20130529
Marketing Category Name ANDA
Labeler Name REMEDYREPACK INC.
Substance Name ISOSORBIDE MONONITRATE
Strength Number 60
Strength Unit mg/1
Pharmaceutical Classes Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]

Complete Information of Isosorbide


General Information