Isosorbide mononitrate tablet

Ingredients and appearance - Product information

Isosorbide mononitrate tablet- Isosorbide mononitrate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 61786-886
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Isosorbide mononitrate ( UNII: LX1OH63030)( Isosorbide mononitrate - UNII: LX1OH63030 ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Calcium stearate ( UNII: 776XM7047L)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Starch, corn ( UNII: O8232NY3SJ)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Talc ( UNII: 7SEV7J4R1U)

Product Characteristics

Color blue Imprint Code R;631
Score 2 Shape ROUND
Size 7 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 61786-886-02 30 in 1 BLISTER PACK 2016/09/19

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075037 USA 2016/09/19

Labeler - REMEDYREPACK INC.( 829572556)

Package label.principal display panel

DRUG: Isosorbide Mononitrate

GENERIC: Isosorbide Mononitrate

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-886-02

COLOR: blue

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 7 mm

IMPRINT: R;631

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ISOSORBIDE MONONITRATE 10mg in 1

INACTIVE INGREDIENT(S):

  • CALCIUM STEARATE
  • LACTOSE MONOHYDRATE
  • MICROCRYSTALLINE CELLULOSE
  • FD&C BLUE NO. 1
  • SILICON DIOXIDE
  • STARCH, CORN
  • TALC