Isosorbide tablet, extended release

Ingredients and appearance - Product information

Isosorbide tablet, extended release- Isosorbide mononitrate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 52125-059
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Isosorbide mononitrate ( UNII: LX1OH63030)( Isosorbide mononitrate - UNII: LX1OH63030 ) 30 mgin 1

Inactive Ingredients

Ingredient Name Code
Ammonium phosphate, dibasic ( UNII: 10LGE70FSU)
Carnauba wax ( UNII: R12CBM0EIZ)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Magnesium stearate ( UNII: 70097M6I30)
Polyethylene glycol ( UNII: 3WJQ0SDW1A)
Ferric oxide red ( UNII: 1K09F3G675)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color pink Score 2
Shape OVAL (TABLET, EXTENDED RELEASE) Imprint Code WW;30
Size 6 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 52125-059-02 30 in 1 BLISTER PACK 2012/07/24

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076813 USA 2012/07/24

Labeler - REMEDYREPACK INC.( 829572556)