Indications and uses
Dipyridamole Tablets, USP are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.
DIPYRIDAMOLE TABLETS, USP 25 mg, 50 mg, and 75 mg
- Manufacturer
- Lannett Company, Inc.
- Effective date
- 2010-11-24
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 8
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:56:14
Label at a glance#
ProductDipyridamole
Active ingredientDIPYRIDAMOLE
Label structure11 sections
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.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Rx only
Prescribing Information
DESCRIPTION
Dipyridamole, USP is a platelet inhibitor chemically described as 2,2',2'',2'''-[(4,8-Dipiperidinopyrimido[5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula:
Dipyridamole is an odorless yellow crystalline powder, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and practically insoluble in water.
Dipyridamole Tablets USP, 25 mg, 50 mg and 75 mg for oral administration contain 25 mg, 50 mg, and 75 mg of dipyridamole, USP, respectively.
Inactive ingredients for Dipyridamole Tablets USP, 25 mg, 50 mg, and 75 mg: microcrystalline cellulose, povidone, crospovidone, lactose monohydrate, colloidal silicon dioxide, magnesium stearate, FD&C Red # 40 aluminum lake, FD&C Yellow #6 aluminum lake, lecithin, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
CLINICAL PHARMACOLOGY
It is believed that platelet reactivity and interaction with prosthetic cardiac valve surfaces, resulting in abnormally shortened platelet survival time, is a significant factor in thromboembolic complications occurring in connection with prosthetic heart valve replacement.
Dipyridamole tablets have been found to lengthen abnormally shortened platelet survival time in a dose-dependent manner.
In three randomized controlled clinical trials involving 854 patients who had undergone surgical placement of a prosthetic heart valve, dipyridamole tablets, in combination with warfarin, decreased the incidence of postoperative thromboembolic events by 62 to 91% compared to warfarin treatment alone. The incidence of thromboembolic events in patients receiving the combination of dipyridamole tablets and warfarin ranged from 1.2 to 1.8%. In three additional studies involving 392 patients taking dipyridamole tablets and coumarin-like anticoagulants, the incidence of thromboembolic events ranged from 2.3 to 6.9%.
In these trials, the coumarin anticoagulant was begun between 24 hours and 4 days postoperatively, and the dipyridamole tablets were begun between 24 hours and 10 days postoperatively. The length of follow-up in these trials varied from 1 to 2 years.
Dipyridamole tablets do not influence prothrombin time or activity measurements when administered with warfarin.
Mechanism of Action
Dipyridamole inhibits the uptake of adenosine into platelets, endothelial cells and erythrocytes in vitro and in vivo; the inhibition occurs in a dose-dependent manner at therapeutic concentrations (0.5 to 1.9 mcg/mL). This inhibition results in an increase in local concentrations of adenosine which acts on the platelet A2-receptor thereby stimulating platelet adenylate cyclase and increasing platelet cyclic-3',5'-adenosine monophosphate (cAMP) levels. Via this mechanism, platelet aggregation is inhibited in response to various stimuli such as platelet activating factor (PAF), collagen and adenosine diphosphate (ADP).
Dipyridamole inhibits phosphodiesterase (PDE) in various tissues. While the inhibition of cAMP-PDE is weak, therapeutic levels of dipyridamole inhibit cyclic-3',5'-guanosine monophosphate-PDE (cGMP-PDE), thereby augmenting the increase in cGMP produced by EDRF (endothelium-derived relaxing factor, now identified as nitric oxide).
Hemodynamics
In dogs, intraduodenal doses of dipyridamole of 0.5 to 4.0 mg/kg produced dose-related decreases in systemic and coronary vascular resistance leading to decreases in systemic blood pressure and increases in coronary blood flow. Onset of action was in about 24 minutes and effects persisted for about 3 hours.
Similar effects were observed following IV dipyridamole in doses ranging from 0.025 to 2.0 mg/kg.
In man the same qualitative hemodynamic effects have been observed. However, acute intravenous administration of dipyridamole may worsen regional myocardial perfusion distal to partial occlusion of coronary arteries.
Pharmacokinetics and Metabolism
Following an oral dose of dipyridamole tablets, the average time to peak concentration is about 75 minutes. The decline in plasma concentration following a dose of dipyridamole tablets fits a two-compartment model. The alpha half-life (the initial decline following peak concentration) is approximately 40 minutes. The beta half-life (the terminal decline in plasma concentration) is approximately 10 hours. Dipyridamole is highly bound to plasma proteins. It is metabolized in the liver where it is conjugated as a glucuronide and excreted with the bile.
INDICATIONS AND USAGE
Dipyridamole Tablets, USP are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.
CONTRAINDICATIONS
Hypersensitivity to dipyridamole and any of the other components.
PRECAUTIONS
General
Coronary Artery Disease
Dipyridamole has a vasodilatory effect and should be used with caution in patients with severe coronary artery disease (e.g., unstable angina or recently sustained myocardial infarction). Chest pain may be aggravated in patients with underlying coronary artery disease who are receiving dipyridamole.
Hepatic Insufficiency
Elevations of hepatic enzymes and hepatic failure have been reported in association with dipyridamole administration.
Hypotension
Dipyridamole should be used with caution in patients with hypotension since it can produce peripheral vasodilation.
Laboratory Tests
Dipyridamole has been associated with elevated hepatic enzymes.
Drug Interactions
No pharmacokinetic drug-drug interaction studies were conducted with dipyridamole tablets. The following information was obtained from the literature.
Adenosine
Dipyridamole has been reported to increase the plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage may be necessary.
Cholinesterase Inhibitors
Dipyridamole may counteract the antcholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In studies in which dipyridamole was administered in the feed to mice (up to 111 weeks in males and females) and rats (up to 128 weeks in males and up to 142 weeks in females), there was no evidence of drug-related carcinogenesis. The highest dose administered in these studies (75 mg/kg/day) was, on a mg/m2 basis, about equivalent to the maximum recommended daily human oral dose (MRHD) in mice and about twice the MRHD in rats. Mutagenicity tests of dipyridamole with bacterial and mammalian cell systems were negative. There was no evidence of impaired fertility when dipyridamole was administered to male and female rats at oral doses up to 500 mg/kg/day (about 12 times the MRHD on a mg/m2 basis). A significant reduction in number of corpora lutea with consequent reduction in implantations and live fetuses was, however, observed at 1250 mg/kg (more than 30 times the MRHD on a mg/m2 basis).
Pregnancy
Teratogenic Effects
PREGNANCY CATEGORY B
Reproduction studies have been performed in mice, rabbits and rats at oral dipyridamole doses of up to 125 mg/kg, 40 mg/kg and 1000 mg/kg, respectively (about 1 ½, 2 and 25 times the maximum recommended daily human oral dose, respectively, on a mg/m2 basis) and have revealed no evidence of harm to the fetus due to dipyridamole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, dipyridamole should be used during pregnancy only if clearly needed.
Nursing Mothers
As dipyridamole is excreted in human milk, caution should be exercised when dipyridamole tablets are administered to a nursing woman.
Pediatric Use
Safety and effectiveness in the pediatric population below the age of 12 years have not been established.
ADVERSE REACTIONS
Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of dipyridamole tablets initial side effects usually disappear. The following reactions in Table 1 were reported in two heart valve replacement trials comparing dipyridamole tablets and warfarin therapy to either warfarin alone or warfarin and placebo:
| Adverse Reaction | Dipyridamole Tablets/ Warfarin | Placebo/ Warfarin |
|---|---|---|
| Number of patients | 147 | 170 |
| Dizziness | 13.6% | 8.2% |
| Abdominal distress | 6.1% | 3.5% |
| Headache | 2.3% | 0.0% |
| Rash | 2.3% | 1.1% |
Other reactions from uncontrolled studies include diarrhea, vomiting, flushing and pruritus. In addition, angina pectoris has been reported rarely and there have been rare reports of liver dysfunction. On those uncommon occasions when adverse reactions have been persistent or intolerable, they have ceased on withdrawal of the medication.
When dipyridamole tablets were administered concomitantly with warfarin, bleeding was no greater in frequency or severity than that observed when warfarin was administered alone. In rare cases, increased bleeding during or after surgery has been observed.
In post-marketing reporting experience, there have been rare reports of hypersensitivity reactions (such as rash, urticaria, severe bronchospasm, and angioedema), larynx edema, fatigue, malaise, myalgia, arthritis, nausea, dyspepsia, paresthesia, hepatitis, thrombocytopenia, alopecia, cholelithiasis, hypotension, palpitation, and tachycardia.
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 orange, round, film-coated tablets debossed "LCI" on one side and "1461" on the other side and are available in bottles of:
100 tablets NDC 0527-1461-01
500 tablets NDC 0527-1461-05
1000 tablets NDC 0527-1461-10
Dipyridamole Tablets USP, 50 mg are orange, round, film-coated tablets debossed "LCI" on one side and "1462" on the other side and are available in bottles of:
100 tablets NDC 0527-1462-01
500 tablets NDC 0527-1462-05
1000 tablets NDC 0527-1462-10
Dipyridamole Tablets USP, 75 mg are orange, round, film-coated tablets debossed "LCI" on one side and "1463" on the other side and are available in bottles of:
100 tablets NDC 0527-1463-01
500 tablets NDC 0527-1463-05
1000 tablets NDC 0527-1463-10
Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].
KEEP OUT OF REACH OF CHILDREN.
Dispense in tight, light-resistant containers as defined in the USP.
Manufactured By:
Lannett Company, Inc.
Philadelphia, PA 19136
Rev. 01/08
PRINCIPAL DISPLAY PANEL
NDC 0527-1461-01
Lannett
DIPYRIDAMOLE TABLETS, USP
25 mg
Rx Only
100 TABLETS
NDC 0527-1462-01
Lannett
DIPYRIDAMOLE TABLETS, USP
50 mg
Rx Only
100 TABLETS
NDC 0527-1463-01
Lannett
DIPYRIDAMOLE TABLETS, USP
75 mg
Rx Only
100 TABLETS
FDA-Initiated Inactive NDC Indexing#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0527-1461-01 | EA - Each | 0527-1461 | c58228a1-dca5-4f8d-8bd7-d3d97f3aa1f5 | 1 | 2012-07-24 |
| 0527-1461-10 | EA - Each | 0527-1461 | 41e3ccb4-b595-4f42-a1d6-171181e30bf6 | 1 | 2012-07-24 |
| 0527-1462-01 | EA - Each | 0527-1462 | e970ab01-48b1-4e09-bd16-1534708f5aad | 1 | 2012-07-24 |
| 0527-1462-10 | EA - Each | 0527-1462 | 9e354425-e186-42f0-92ec-e4d9d084056a | 1 | 2012-07-24 |
| 0527-1463-01 | EA - Each | 0527-1463 | 1edbfa9f-4998-482f-abcf-1e96b8487ca2 | 1 | 2012-07-24 |
| 0527-1463-10 | EA - Each | 0527-1463 | 4673cf38-57af-4883-b4c7-0c496a0830d4 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DIPYRIDAMOLE | ACTIVE INGREDIENT | 64ALC7F90C | 4 | |
| DIPYRIDAMOLE | ACTIVE MOIETY | 64ALC7F90C | 4 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 4 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 4 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 4 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 4 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | 4 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | 4 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 4 |
Products#
Every source-derived product name is available through these pages.
- Dipyridamole
- CELLULOSE, MICROCRYSTALLINE
- POVIDONE
- CROSPOVIDONE
- LACTOSE MONOHYDRATE
- SILICON DIOXIDE
- MAGNESIUM STEARATE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- LECITHIN, SOYBEAN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- TALC
- TITANIUM DIOXIDE
- ALUMINUM OXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0527-1461 | 0527-1461-01, 0527-1461-05, 0527-1461-10 |
| 0527-1462 | 0527-1462-01, 0527-1462-05, 0527-1462-10 |
| 0527-1463 | 0527-1463-01, 0527-1463-05, 0527-1463-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SOLUTION / ORAL | 40 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION / ORAL | 11 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 60 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | TABLET / ORAL | 165 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING / ORAL | 80 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / BUCCAL | 1 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 150 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE / ORAL | 7 mg | ||
| TALC | TALC | 7SEV7J4R1U | PELLET / ORAL | 69 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INHALANT / ORAL | NA | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 690 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED / ORAL | 968 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION / SUBCUTANEOUS | 98 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / SUBLINGUAL | NA | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SOLUTION/ DROPS / OPHTHALMIC | 1.4 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, EXTENDED RELEASE / ORAL | 5364 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, FILM COATED / ORAL | 1 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE / ORAL | 202 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / BUCCAL | 43 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, FOR SUSPENSION / ORAL | 296 mg | ||
| TALC | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.02 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / ORAL | 7 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED PELLETS / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040898-001 | DIPYRIDAMOLE | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | ||
| A040898-002 | DIPYRIDAMOLE | DIPYRIDAMOLE | 50MG | TABLET / ORAL | 2008-04-23 | ||
| A040898-003 | DIPYRIDAMOLE | DIPYRIDAMOLE | 75MG | TABLET / ORAL | 2008-04-23 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040898-001 | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040898-002 | DIPYRIDAMOLE | 50MG | TABLET / ORAL | 2008-04-23 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040898-003 | DIPYRIDAMOLE | 75MG | TABLET / ORAL | 2008-04-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040898-001 | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040898-002 | DIPYRIDAMOLE | 50MG | TABLET / ORAL | 2008-04-23 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040898-003 | DIPYRIDAMOLE | 75MG | TABLET / ORAL | 2008-04-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040898-001 | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040898-002 | DIPYRIDAMOLE | 50MG | TABLET / ORAL | 2008-04-23 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040898-003 | DIPYRIDAMOLE | 75MG | TABLET / ORAL | 2008-04-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040898-001 | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040898-002 | DIPYRIDAMOLE | 50MG | TABLET / ORAL | 2008-04-23 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040898-003 | DIPYRIDAMOLE | 75MG | TABLET / ORAL | 2008-04-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040898-001 | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040898-002 | DIPYRIDAMOLE | 50MG | TABLET / ORAL | 2008-04-23 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040898-003 | DIPYRIDAMOLE | 75MG | TABLET / ORAL | 2008-04-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040898-001 | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040898-002 | DIPYRIDAMOLE | 50MG | TABLET / ORAL | 2008-04-23 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040898-003 | DIPYRIDAMOLE | 75MG | TABLET / ORAL | 2008-04-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040898-001 | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040898-002 | DIPYRIDAMOLE | 50MG | TABLET / ORAL | 2008-04-23 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040898-003 | DIPYRIDAMOLE | 75MG | TABLET / ORAL | 2008-04-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040898-001 | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040898-002 | DIPYRIDAMOLE | 50MG | TABLET / ORAL | 2008-04-23 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040898-003 | DIPYRIDAMOLE | 75MG | TABLET / ORAL | 2008-04-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040898-001 | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040898-002 | DIPYRIDAMOLE | 50MG | TABLET / ORAL | 2008-04-23 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040898-003 | DIPYRIDAMOLE | 75MG | TABLET / ORAL | 2008-04-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040898-001 | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040898-002 | DIPYRIDAMOLE | 50MG | TABLET / ORAL | 2008-04-23 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040898-003 | DIPYRIDAMOLE | 75MG | TABLET / ORAL | 2008-04-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040898-001 | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040898-002 | DIPYRIDAMOLE | 50MG | TABLET / ORAL | 2008-04-23 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040898-003 | DIPYRIDAMOLE | 75MG | TABLET / ORAL | 2008-04-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040898-001 | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040898-002 | DIPYRIDAMOLE | 50MG | TABLET / ORAL | 2008-04-23 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040898-003 | DIPYRIDAMOLE | 75MG | TABLET / ORAL | 2008-04-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040898-001 | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040898-002 | DIPYRIDAMOLE | 50MG | TABLET / ORAL | 2008-04-23 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040898-003 | DIPYRIDAMOLE | 75MG | TABLET / ORAL | 2008-04-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040898-001 | DIPYRIDAMOLE | 25MG | TABLET / ORAL | 2008-04-23 | 301d65b070ca… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4eac07e2-a24d-4b04-b6a9-a93db459bcbf | 1b82871b-f60b-4485-9a45-026aeb18b484 | 2010-11-24 | Adverse reactions | 1b82871b-f60b-4485-9a45-026aeb18b484 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.