Isosorbide (Page 3 of 3)

HOW SUPPLIED

Isosorbide Dinitrate Tablets, USP 5 mg: White, Round, Scored Tablets Debossed “West-ward 769”.

NDC 68001-373-00 Bottles of 100

Isosorbide Dinitrate Tablets, USP 10 mg: White, Round, Scored Tablets Debossed “WW” on one side and “771” on the other side.

NDC 68001-374-00 Bottles of 100

Isosorbide Dinitrate Tablets, USP 20 mg: Green, Round, Scored Tablets Debossed “WW” on one side and “772” on the other side.

NDC 68001-375-00 Bottles of 100

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Manufactured by:
Hikma Pharmaceuticals
P.O. Box 182400, Amman 11118-Jordan

For BluePoint Laboratories

PRINCIPAL DISPLAY PANEL

Isosorbide Dinitrate Tablets, USP 5mg

NDC 68001-373-00

PRINCIPAL DISPLAY PANEL

Isosorbide Dinitrate Tablets, USP 10mg

NDC 68001-374-00

PRINCIPAL DISPLAY PANEL

Isosorbide Dinitrate Tablets, USP 20mg

NDC 68001-375-00

ISOSORBIDE isosorbide dinitrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-373 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE 5 mg

Inactive Ingredients Ingredient Name Strength AMMONIUM PHOSPHATE, DIBASIC ANHYDROUS LACTOSE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE (WHITE) Score 2 pieces Shape ROUND (ROUND) Size 8mm Flavor Imprint Code West;ward;769 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68001-373-00 100 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA086067 11/30/2018

ISOSORBIDE isosorbide dinitrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-374 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE 10 mg

Inactive Ingredients Ingredient Name Strength AMMONIUM PHOSPHATE, DIBASIC ANHYDROUS LACTOSE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE (WHITE) Score 2 pieces Shape ROUND (ROUND) Size 8mm Flavor Imprint Code WW;771 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68001-374-00 100 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA086066 11/30/2018

ISOSORBIDE isosorbide dinitrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-375 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE) ISOSORBIDE DINITRATE 20 mg

Inactive Ingredients Ingredient Name Strength AMMONIUM PHOSPHATE, DIBASIC ANHYDROUS LACTOSE D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C YELLOW NO. 6 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color GREEN (GREEN) Score 2 pieces Shape ROUND (ROUND) Size 8mm Flavor Imprint Code WW;772 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68001-375-00 100 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA088088 11/30/2018

Labeler — BluePoint Laboratories (985523874)

Registrant — Hikma Pharmaceutical LLC (534662643)

Establishment
Name	Address	ID/FEI	Operations
Hikma Pharmaceutical LLC		534662643	MANUFACTURE (68001-373), MANUFACTURE (68001-374), MANUFACTURE (68001-375)

Revised: 11/2018 BluePoint Laboratories