Isosorbide mononitrate tablet, film coated, extended release

Ingredients and appearance - Product information

Isosorbide mononitrate tablet, film coated, extended release- Isosorbide mononitrate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68084-435
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 glycols ( UNII: 3WJQ0SDW1A)
Ferric oxide red ( UNII: 1K09F3G675)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color PINK (LIGHT ROSE) Size 6 mm
Shape OVAL (OVAL) Score 2
Imprint Code WW;30

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076813 USA

Isosorbide mononitrate tablet, film coated, extended release- Isosorbide mononitrate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68084-436
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Isosorbide mononitrate ( UNII: LX1OH63030)( Isosorbide mononitrate - UNII: LX1OH63030 ) 60 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)
Ferric oxide yellow ( UNII: EX438O2MRT)
Titanium dioxide ( UNII: 15FIX9V2JP)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)

Product Characteristics

Color YELLOW (LIGHT YELLOW) Size 6 mm
Shape OVAL (OVAL) Score 2
Imprint Code WW;60

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076813 USA

Labeler - American Health Packaging( 929561009)

Establishment

Name ID/FEI Business Operations
American Health Packaging 929561009 REPACK( 68084-435, 68084-436)