Data updated: May 26, 2026
HEPARIN SODIUM
Genetically Validated
Cardiovascular
Approved 1939-02-09
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 car...
Source: FDA Label • SAGENT PHARMS
33
Indications
--
Phase 3 Trials
1
Priority Reviews
87
Years on Market
Details
- Status
- Prescription
- First Approved
- 1939-02-09
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
SAGENT PHARMS PLANO PHARMS Pfizer EMERGE BIOSCIENCE PHARMACIA AND UPJOHN Dr. Reddy's SHENZHEN TECHDOW WATSON LABS INC SOLOPAK CASI PHARMS INC Hikma PHARM SPEC ABRAXIS PHARM Fresenius Kabi LUITPOLD PHARMOBEDIENT BE PHARMS Eli Lilly B BRAUN MEDICAL EPIC PHARMA LLC DELL LABS ASPEN GLOBAL INC GLAND CHAMBERLIN PARENTERL SMITH AND NEPHEW PARKE DAVIS
Active Ingredient: HEPARIN SODIUM
Website: ↗
HEPARIN SODIUM Approval History
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2285 FDA actions from 1939 to 2026 · 3 indication expansions
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What HEPARIN SODIUM Treats
33 FDA approvalsOriginally approved for its first indication in 1939 . Covers 33 distinct patient populations.
- Other (33)
Other
(33 approvals)- • Approved indication (Feb 1939)
- • Approved indication (Feb 1942)
- • Approved indication (May 1944)
- • Approved indication (Feb 1972)
- • Approved indication (Mar 1972)
- • Approved indication (May 1974) Priority
- • Approved indication (Nov 1974)
- • Approved indication (Dec 1975)
- • Approved indication (Feb 1978)
- • Approved indication (Apr 1978)
- • Approved indication (Dec 1978)
- • Approved indication (Apr 1983)
- • Approved indication (Dec 1983)
- • Approved indication (Jun 1984)
- • Approved indication (Jul 1985)
- • Approved indication (Apr 1986)
- • Approved indication (Oct 1995)
- • Approved indication (Jun 1996)
- • Approved indication (Jul 1996)
- • Approved indication (Aug 2009)
- • Approved indication (Jun 2010)
- • Approved indication (Jun 2011)
- • Approved indication (Jul 2011)Label Letter
- • Approved indication (Jun 2014)
- • Approved indication (Jun 2016)Label Letter
- • Approved indication (Feb 2017)Letter
- • Approved indication (Nov 2017)Letter
- • Approved indication (Nov 2018)
- • Approved indication (Dec 2018)
- • Approved indication (May 2019)
- • Approved indication (Feb 2020)
- • Approved indication (Jul 2020)
- • Approved indication (Dec 2020)
HEPARIN SODIUM 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.
📋
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 |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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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 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 ...
Looking for the branded version?
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Full clinical data, patents, trials, and competitive landscape for heparin sodium.
Data Sources
FDA Approval: ANDA090808 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →
Data sourced from official FDA and NIH databases. Click links to verify on original sources.