HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium)
Heparin Sodium is an anticoagulant indicated for the prophylaxis and treatment of venous thrombosis, pulmonary embolism, and peripheral arterial embolism. It is utilized for the prevention of postoperative deep venous thrombosis (DVT) and pulmonary embolism in patients undergoing major abdominothoracic surgery or those at high risk for thromboembolic complications. It is also indicated for the management of atrial fibrillation with embolization and the treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation). Additionally, Heparin Sodium is used to prevent clotting in arterial and cardiac surgery, and as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures.
How HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Works
Heparin functions as an indirect anticoagulant by binding to antithrombin III (ATIII), inducing a conformational change that significantly accelerates ATIII's inhibition of activated coagulation factors, specifically Factor Xa and Factor IIa (thrombin). Low doses of heparin primarily inhibit Factor Xa, while higher doses inhibit thrombin, preventing the conversion of fibrinogen to fibrin. Heparin also inhibits the activation of fibrin-stabilizing factor, preventing the formation of stable fibrin clots. Notably, heparin lacks fibrinolytic activity and does not lyse existing thrombi.
Details
- Status
- Prescription
- First Approved
- 1984-01-31
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Approval History
What HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Treats
5 FDA approvalsOriginally approved for its first indication in 1984 . Covers 5 distinct patient populations.
- Other (5)
Other
(5 approvals)- • Approved indication (Jan 1984)
- • Approved indication (Mar 1985)
- • Approved indication (Jun 1989)
- • Approved indication (Jul 1992)
- • Approved indication (Jul 2020)
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Target & Pathway
ProTarget
A key enzyme in the blood clotting cascade that converts prothrombin to thrombin. Inhibiting Factor Xa prevents clot formation, reducing risk of stroke in atrial fibrillation and treating/preventing venous thromboembolism.
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06646328 | FER-CIT-2016-01 2016-004361-12 | Ph 4 | terminated | Oxidative Stress and Circulating Nuclear DNA (cfDNA) in Acute Kidney Injury and Continuous Renal Replacement Therapies. |
| NCT04743011 EnHanCed results posted | UPECLIN-MB-2 | Ph 1, Ph 2 | completed | Enriched Heparin Anti COVID-19 Trial |
| NCT03707418 | IRB00176475 | Ph 1 | withdrawn | Bivalirudin vs Heparin in ECMO Patients |
| NCT02206087 | PER977-01-002 | Ph 1, Ph 2 | completed | Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PER977 Following Heparin |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
FDA Label (PDF)Heparin Sodium Injection is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism; Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; Atrial fibrillation with embolization; Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); Prevention of clotting in arterial and cardiac surgery; Prophylaxis and treatment of peripheral arterial embolism. Anticoagulant use in blood ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.