HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER (heparin sodium) · B BRAUN
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER is FDA-approved to treat 8 conditions (same as HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER).
Details
- Status
- Prescription
- First Approved
- 1985-03-27
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER Approval History
What HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER Treats
8 indicationsHEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER is approved for 8 conditions since its original approval in 1985. 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
Same approved indications as HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (same active ingredient).
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| NCT03707418 | IRB00176475 | Ph 1 | withdrawn | Bivalirudin vs Heparin in ECMO Patients |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 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
FDA Label (PDF)HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER is FDA-approved to treat 8 conditions — same approved indications as HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.