Isosorbide Dinitrate: Package Insert and Label Information (Page 2 of 2)

HOW SUPPLIED

Product: 63739-367

NDC: 63739-367-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

Product: 63739-569

NDC: 63739-569-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

CLINICAL STUDIES

In clinical trials, immediate-release oral isosorbide dinitrate has been administered in a variety of regimens, with total daily doses ranging from 30 mg to 480 mg. Controlled trials of single oral doses of isosorbide dinitrate have demonstrated effective reductions in exercise-related angina for up to 8 hours. Anti-anginal activity is present about 1 hour after dosing.

Most controlled trials of multiple-dose oral isosorbide dinitrate taken every 12 hours (or more frequently) for several weeks have shown statistically significant anti-anginal efficacy for only 2 hours after dosing. Once-daily regimens, and regimens with one daily dose-free interval of at least 14 hours ( e.g. , a regimen providing doses at 0800, 1400 and 1800 hours), have shown efficacy after the first dose of each day that was similar to that shown in the single-dose studies cited above. The effects of the second and later doses have been smaller and shorter-lasting than the effect of the first.

From large, well-controlled studies of other nitrates, it is reasonable to believe that the maximal achievable daily duration of anti-anginal effect from isosorbide dinitrate is about 12 hours. No dosing regimen for isosorbide dinitrate, however, has ever actually been shown to achieve this duration of effect. One study of 8 patients, who were administered a pretitrated dose (average 27.5 mg) of immediate-release isosorbide dinitrate at 0800, 1300, and 1800 hours for 2 weeks, revealed that significant anti-anginal effectiveness was discontinuous and totaled about 6 hours in a 24 hour period.

Manufactured by:

PAR PHARMACEUTICAL

Chestnut Ridge, NY 10977

Revised 02/2016

Isosorbide Dinitrate Tablets, USP

Label Image
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Isosorbide Dinitrate Tablets, USP

Label Image
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ISOSORBIDE DINITRATE
isosorbide dinitrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-367(NDC:49884-022)
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
FD&C BLUE NO. 1
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A CORN
ISOPROPYL ALCOHOL
Product Characteristics
Color green Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code Par;022
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-367-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-367-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087537 12/15/1981
ISOSORBIDE DINITRATE
isosorbide dinitrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-569(NDC:49884-021)
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
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
MAGNESIUM STEARATE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code Par;021
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-569-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-569-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086925 12/22/1979
Labeler — McKesson Corporation dba SKY Packaging (140529962)
Establishment
Name Address ID/FEI Operations
Legacy Pharmaceutical Packaging, LLC 143213275 repack (63739-367), repack (63739-569), relabel (63739-367), relabel (63739-569)

Revised: 11/2020 McKesson Corporation dba SKY Packaging

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