Dipyridamole (Page 2 of 2)

OVERDOSAGE

In case of real or suspected overdose, seek medical attention or contact a Poison Control Center immediately. Careful medical management is essential. Based upon the known hemodynamic effects of dipyridamole, symptoms such as warm feeling, flushes, sweating, restlessness, feeling of weakness and dizziness may occur. A drop in blood pressure and tachycardia might also be observed.

Symptomatic treatment is recommended, possibly including a vasopressor drug. Gastric lavage should be considered. Administration of xanthine derivatives (e.g., aminophylline) may reverse the hemodynamic effects of dipyridamole overdose. Since dipyridamole is highly protein bound, dialysis is not likely to be of benefit.

DOSAGE AND ADMINISTRATION

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement:

The recommended dose is 75 to 100 mg four times daily as an adjunct to the usual warfarin therapy. Please note that aspirin is not to be administered concomitantly with coumarin anticoagulants.

HOW SUPPLIED

Dipyridamole Tablets USP, 25 mg are light yellow, round, biconvex, film-coated tablets debossed with ‘ZE 43′ on one side and plain on the other side are supplied as follows:

NDC 65841-662-01 in bottle of 100 tablets

NDC 65841-662-05 in bottle of 500 tablets

NDC 65841-662-10 in bottle of 1000 tablets

NDC 65841-662-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

Dipyridamole Tablets USP, 50 mg are light yellow, round, biconvex, beveled-edge, film-coated tablets debossed with ‘ZE 49′ on one side and plain on the other side are supplied as follows:

NDC 65841-663-01 in bottle of 100 tablets

NDC 65841-663-05 in bottle of 500 tablets

NDC 65841-663-10 in bottle of 1000 tablets

NDC 65841-663-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

Dipyridamole Tablets USP, 75 mg are light yellow, round, biconvex, beveled-edge, film-coated tablets debossed with ‘ZE 50′ on one side and plain on the other side are supplied as follows:

NDC 65841-664-01 in bottle of 100 tablets

NDC 65841-664-05 in bottle of 500 tablets

NDC 65841-664-10 in bottle of 1000 tablets

NDC 65841-664-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets

Storage:

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep out of reach of children.

Dispense in a tight, light-resistant container.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by:

Cadila Healthcare Ltd.

Ahmedabad, India

Manufactured by:

Cadila Healthcare Ltd.

Baddi, India

Rev.: 09/11

Rivision Date : 2012/03/22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-662-01 in bottle of 100 tablets

Dipyridamole Tablets USP, 25 mg

Rx only

100 tablets

ZYDUS

Dipyridamole Tablets, 25 mg
(click image for full-size original)

NDC 65841-663-01 in bottle of 100 tablets

Dipyridamole Tablets USP, 50 mg

Rx only

100 tablets

ZYDUS

Dipyridamole Tablets, 50 mg
(click image for full-size original)

NDC 65841-664-01 in bottle of 100 tablets

Dipyridamole Tablets USP, 75 mg

Rx only

100 tablets

ZYDUS

Dipyridamole Tablets, 75 mg
(click image for full-size original)
DIPYRIDAMOLE dipyridamole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-662
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPYRIDAMOLE (DIPYRIDAMOLE) DIPYRIDAMOLE 25 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
TITANIUM DIOXIDE
STARCH, CORN
Product Characteristics
Color YELLOW (LIGHT YELLOW) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code ZE;43
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-662-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-662-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-662-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-662-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-662-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040874 05/22/2008
DIPYRIDAMOLE dipyridamole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-663
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPYRIDAMOLE (DIPYRIDAMOLE) DIPYRIDAMOLE 50 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
TITANIUM DIOXIDE
STARCH, CORN
Product Characteristics
Color YELLOW (LIGHT YELLOW) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code ZE;49
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-663-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-663-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-663-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-663-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-663-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040874 05/22/2008
DIPYRIDAMOLE dipyridamole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-664
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPYRIDAMOLE (DIPYRIDAMOLE) DIPYRIDAMOLE 75 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
TITANIUM DIOXIDE
STARCH, CORN
Product Characteristics
Color YELLOW (LIGHT YELLOW) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code ZE;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-664-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:65841-664-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65841-664-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65841-664-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65841-664-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040874 05/22/2008
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-662), ANALYSIS (65841-663), ANALYSIS (65841-664), MANUFACTURE (65841-662), MANUFACTURE (65841-663), MANUFACTURE (65841-664)
Establishment
Name Address ID/FEI Operations
CADILA HEALTHCARE LIMITED 677605858 ANALYSIS (65841-662), ANALYSIS (65841-663), ANALYSIS (65841-664), MANUFACTURE (65841-662), MANUFACTURE (65841-663), MANUFACTURE (65841-664)

Revised: 11/2019 Cadila Healthcare Limited

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