NDC Code(s) : 55154-2175-6, 55154-2175-4, 55154-2175-0, 55154-2176-6, 55154-2176-4, 55154-2176-0
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

isosorbide mononitrateisosorbide mononitrate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-2175(NDC:62175-128)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOSORBIDE MONONITRATE(UNII: LX1OH63030)
(ISOSORBIDE MONONITRATE - UNII:LX1OH63030) 		ISOSORBIDE MONONITRATE30 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score 2 pieces
Shape CAPSULE Size 9 mm
Flavor Imprint Code KU;128;
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-2175-4100 in 1 CARTON 30/10/1998
1NDC:55154-2175-61 in 1 POUCH Type 0: Not a Combination Product
2NDC:55154-2175-010 in 1 BAG 30/10/1998
21 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075155 10/30/1998 02/29/2012
isosorbide mononitrateisosorbide mononitrate TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-2176(NDC:62175-119)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOSORBIDE MONONITRATE(UNII: LX1OH63030)
(ISOSORBIDE MONONITRATE - UNII:LX1OH63030) 		ISOSORBIDE MONONITRATE60 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score 2 pieces
Shape CAPSULE Size 15 mm
Flavor Imprint Code KU;119;
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-2176-4100 in 1 CARTON 30/10/1998
1NDC:55154-2176-61 in 1 POUCH Type 0: Not a Combination Product
2NDC:55154-2176-010 in 1 BAG 30/10/1998
21 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075155 10/30/1998 01/31/2012

PRINCIPAL DISPLAY PANEL

Isosorbide Mononitrate

Extended-Release Tablets, USP

30 mg

100 Tablets

30 mg carton label

PRINCIPAL DISPLAY PANEL

Isosorbide Mononitrate

Extended-Release Tablet, USP

30 mg

Pouch Label

PRINCIPAL DISPLAY PANEL

NDC: 55154-2175-0

Isosorbide Mononitrate

30 mg

Extended-Release Tablets, USP

10 Tablets

Bag Label

PRINCIPAL DISPLAY PANEL

Isosorbide Mononitrate

Extended-Release Tablets, USP

60 mg

100 Tablets

Isosorbide Mono. Carton Label

PRINCIPAL DISPLAY PANEL

Isosorbide Mononitrate

Extended-Release Tablet, USP

60 mg

Pouch Label

PRINCIPAL DISPLAY PANEL

NDC: 55154-2176-0

Isosorbide Mononitrate

60 mg

Extended-Release Tablets, USP

10 Tablets

Bag Label