Isosorbide Dinitrate (Page 3 of 3)

HOW SUPPLIED

Isosorbide dinitrate tablets, USP are available as follows:

5 mg oral, white, round, bisected tablets, debossed with “PAR 020” on one side and plain on the other side.

NDC 50268-447-15 (10 tablets per card, 5 cards per carton).

10 mg oral, white, round, bisected tablets, debossed with “PAR 021” on one side and plain on the other side.
NDC 50268-448-15 (10 tablets per card, 5 cards per carton).

20 mg oral, green, round, bisected tablets, debossed with “PAR 022” on one side and plain on the other side.

NDC 50268-449-15 (10 tablets per card, 5 cards per carton).

30 mg oral, blue, round, bisected tablets, debossed with “PAR 009” on one side and plain on the other side.

Dispensed in Unit Dose Package. For Institutional Use Only.

Store at room temperature, approximately 25°C (77°F). Protect from light. Keep bottles tightly closed.

Dispense in a light-resistant, tight container.

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 for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 02/16
AV Rev. 05/17 (P)
AvPAK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50268-447-15
Isosorbide Dinitrate Tablets, USP Oral
5mg
Rx Only
50 Tablets (5×10) Unit Dose
5026844715
NDC 50268-447-15
Isosorbide Dinitrate Tablets, USP Oral
5mg
Rx Only
50 Tablets (5×10) Unit Dose
5026844715

Each tablet contains:
Isosorbide Dinitrate …………………………………………………. 5 mg
Usual Dosage:
Read Accompanying Literature.
Dispense in a light-resistant, tight container.

Store at room temperature, approximately 25°C (77°F).
Protect from light.
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A Product of AvKARE
Mfg. Rev. 01/13 AV 09/16 (P)

label 1
(click image for full-size original)

NDC 50268-448-15
Isosorbide Dinitrate Tablets, USP Oral
10mg
Rx Only
50 Tablets (5×10) Unit Dose
5026844815
NDC 50268-448-15
Isosorbide Dinitrate Tablets, USP Oral
10mg
Rx Only
50 Tablets (5×10) Unit Dose
5026844815
Each tablet contains:
Isosorbide Dinitrate …………………………………………………. 10 mg
Usual Dosage:
Read Accompanying Literature.
Dispense in a light-resistant, tight container.
Store at room temperature, approximately 25°C (77°F).
Protect from light.
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
AvPAK
A Product of AvKARE Mfg. Rev. 02/16 AV Rev. 06/17(P)

3
(click image for full-size original)

NDC 50268-449-15
Isosorbide Dinitrate Tablets, USP Oral
20mg
Rx Only
50 Tablets (5×10) Unit Dose
5026844915
NDC 50268-449-15
Isosorbide Dinitrate Tablets, USP Oral
20mg
Rx Only
50 Tablets (5×10) Unit Dose
5026844915

Each tablet contains:
Isosorbide Dinitrate …………………………………………………. 20 mg
Usual Dosage:
Read Accompanying Literature.
Dispense in a light-resistant, tight container.

Store at room temperature, approximately 25°C (77°F).
Protect from light.
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A Product of AvKARE Mfg. Rev. 01/13 AV 09/16 (P)

label 2
(click image for full-size original)
ISOSORBIDE DINITRATE isosorbide dinitrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-447(NDC:49884-020)
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
ANHYDROUS LACTOSE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code Par;020
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-447-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-447-11)
1 NDC:50268-447-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-447-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086923 09/13/2016
ISOSORBIDE DINITRATE isosorbide dinitrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-449(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
ANHYDROUS LACTOSE
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:50268-449-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-449-11)
1 NDC:50268-449-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-449-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087537 09/13/2016
ISOSORBIDE DINITRATE isosorbide dinitrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-448(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
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:50268-448-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-448-11)
1 NDC:50268-448-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-448-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086925 06/06/2017
Labeler — AvPAK (832926666)

Revised: 05/2018 AvPAK

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