Isosorbide Dinitrate (Page 3 of 3)

HOW SUPPLIED

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

Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6619-61

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

Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6620-61

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

Distributed by:
West-Ward Pharmaceuticals Corp.
Eatontown, NJ 07724 USA

Distributed By:

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Refer to package label for Distributor’s NDC Number

Revised January 2019

Package/Label Display Panel

Isosorbide Dinitrate

10 mg

100 Tablets

carton label
(click image for full-size original)

Package/Label Display Panel

Isosorbide Dinitrate

20 mg

100 Tablets

carton label
(click image for full-size original)
ISOSORBIDE DINITRATE
isosorbide dinitrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6619(NDC:0143-1771)
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:0904-6619-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0904-6619-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086066 12/01/1978
ISOSORBIDE DINITRATE
isosorbide dinitrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6620(NDC:0143-1772)
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:0904-6620-61 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0904-6620-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088088 04/26/1983
Labeler — Major Pharmaceuticals (191427277)

Revised: 12/2021 Major Pharmaceuticals

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