TheraRadar
Data updated: May 26, 2026

DEXTROSE 5% IN PLASTIC CONTAINER (dextrose)

Cardiovascular Approved 1971-02-12

**Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A** is an anticoagulant indicated for use only with specialized devices that prepare Platelet Rich Plasma (PRP) products. It is intended for extracorporeal use, meaning it prevents blood from clotting within the device during the processing phase outside of the body. It is not intended for direct intravenous infusion.

Source: FDA Label • B BRAUN
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How DEXTROSE 5% IN PLASTIC CONTAINER Works

This solution acts as an extracorporeal anticoagulant by binding free calcium ions in the blood. Because calcium is a necessary co-factor for multiple steps in the coagulation cascade, its removal prevents the blood from clotting during processing. The solution utilizes sodium citrate for anticoagulation, citric acid for pH regulation, and dextrose to maintain isotonicity. This solution has no direct pharmacological effect.

Source: FDA Label
10
Indications
--
Phase 3 Trials
55
Years on Market

Details

Status
Prescription
First Approved
1971-02-12
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

B BRAUN OTSUKA ICU MEDCL Pfizer ICU MEDICAL INC Fresenius Kabi Baxter DHL
Active Ingredient: DEXTROSE

DEXTROSE 5% IN PLASTIC CONTAINER Approval History

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Original
New Indication
New Form
Label Update
575 FDA actions from 1971 to 2026
May 2026 SUPPL
Label · Labeling
FDA Letter Label
Jun 2025 SUPPL
Label · Labeling
FDA Letter Label
Jun 2025 SUPPL
Label · Labeling
FDA Letter Label

What DEXTROSE 5% IN PLASTIC CONTAINER Treats

1 indications

DEXTROSE 5% IN PLASTIC CONTAINER is approved for 1 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Blood clotting during extracorporeal Platelet Rich Plasma (PRP) preparation
Source: FDA Label

DEXTROSE 5% IN PLASTIC CONTAINER Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

3

Same indication, different mechanism — what else might this patient receive?

IDKIT:HP
MERIDIAN BIOSCIENCE
2002 2 indic.
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Pfizer
1984 8 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to DEXTROSE 5% IN PLASTIC CONTAINER

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DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
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1 shared
B BRAUN
Shared indications:
Blood clotting during extracorporeal Platelet Rich Plasma (PRP) preparation
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
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1 shared
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Shared indications:
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DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
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Shared indications:
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Clinical Trial Registry

13 trials
Trial Sponsor ID Phase Status Title
NCT07494084 R01HL177106 R01HL177106 Ph 4 not yet recruiting Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance
NCT04895358 3475-B49 MK-3475-B49, KEYNOTE-B49 Ph 3 active not recruiting Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
NCT05264727 22-000306 R01DK116231 Ph 4 active not recruiting Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion
NCT04020601 Pro00092897 Ph 2, Ph 3 terminated The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane in Total Shoulder Arthroplasty
NCT02471690 MDCO-ORI-15-01 Ph 1 completed Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers
NCT03095651 results posted 5160-002 MK-5160-002 Ph 1 completed Multiple Ascending Dose Study of MK-5160 in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-5160-002)
NCT02269735 2640-001 Ph 1 completed A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001)
NCT00578669 results posted PHI0710-002 1R01DA023190 Ph 3 completed Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
NCT01547364 SweetCaudal Ph 2 completed Caudal Epidural Injection of Dextrose For Low Back Pain
NCT02984098 40%D-N-PP POSDRU/159.5/S/133377 Ph 4 completed 40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose
NCT02185729 TPN1 results posted IRB00007543 Ph 2, Ph 3 completed Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers
NCT00878878 results posted GE-191-004 Ph 4 completed Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).
NCT01326611 rö05053781128 Ph 4 completed Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

DEXTROSE 5% IN PLASTIC CONTAINER FDA Label Details

Indications & Usage

FDA Label (PDF)

DEXTROSE 5% IN PLASTIC CONTAINER is indicated for the treatment of Blood clotting during extracorporeal Platelet Rich Plasma (PRP) preparation.

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Data Sources

FDA Approval: NDA019626 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.