HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% 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 used to prevent postoperative deep venous thrombosis (DVT) and pulmonary embolism in patients undergoing major abdominothoracic surgery or those at high risk for thromboembolic disease. Additionally, it is indicated for atrial fibrillation with embolization, the treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation), and as an anticoagulant in blood transfusions, extracorporeal circulation, dialysis, and arterial/cardiac surgery.
How HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Works
Heparin acts by binding to Antithrombin III, inducing a conformational change that markedly enhances its ability to inhibit activated coagulation factors, specifically Factor Xa and Factor IIa (thrombin). By inhibiting these factors and the activation of fibrin stabilizing factor, heparin prevents the formation of stable fibrin clots. Heparin does not possess intrinsic fibrinolytic activity and therefore will not lyse existing thrombi.
Details
- Status
- Prescription
- First Approved
- 1984-01-31
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Approval History
What HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Treats
8 indicationsHEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is approved for 8 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Venous thrombosis
- Pulmonary embolism
- Postoperative deep venous thrombosis
- Atrial fibrillation with embolization
- Disseminated intravascular coagulation
- Clotting during arterial and cardiac surgery
- Peripheral arterial embolism
- Clotting during blood transfusions, extracorporeal circulation, and dialysis procedures
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% 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 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
FDA Label (PDF)HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is indicated for the treatment of Venous thrombosis; Pulmonary embolism; Postoperative deep venous thrombosis; Atrial fibrillation with embolization; Disseminated intravascular coagulation; Clotting during arterial and cardiac surgery; Peripheral arterial embolism; Clotting during blood transfusions, extracorporeal circulation, and dialysis procedures.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.