TheraRadar
Data updated: May 26, 2026

NIPRIDE RTU IN SODIUM CHLORIDE 0.9% (sodium nitroprusside)

Cardiovascular Approved 2017-03-08

NIPRIDE RTU IN SODIUM CHLORIDE 0.9% is indicated for the treatment of Hypertension; Congestive Heart Failure.

Source: FDA Label • EXELA PHARMA
1
Indication
--
Phase 3 Trials
9
Years on Market

Details

Status
Prescription
First Approved
2017-03-08
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: SODIUM NITROPRUSSIDE

NIPRIDE RTU IN SODIUM CHLORIDE 0.9% Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
9 FDA actions from 2017 to 2018
Jul 2018 SUPPL
Mfg · Manufacturing (CMC)
May 2018 SUPPL
Label · Labeling
Mar 2017 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer

What NIPRIDE RTU IN SODIUM CHLORIDE 0.9% Treats

2 indications

NIPRIDE RTU IN SODIUM CHLORIDE 0.9% is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Congestive Heart Failure
Source: FDA Label

NIPRIDE RTU IN SODIUM CHLORIDE 0.9% Boxed Warning

BOXED WARNING Sodium nitroprusside injection is not suitable for direct injection. The solution must be further diluted in sterile 5% dextrose injection before infusion. Sodium nitroprusside injection can cause precipitous decreases in blood pressure (see DOSAGE AND ADMINISTRATION ). In patients not properly monitored, these decreases can lead to irreversible ischemic injuries or death. Sodium nitroprusside should be used only when available equipment and personnel allow blood pressure to be con...

NIPRIDE RTU IN SODIUM CHLORIDE 0.9% Competitive Set

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Clinical Trial Registry

10 trials
Trial Sponsor ID Phase Status Title
NCT03318094 162097 Ph 1 active not recruiting Role of Sympathetic Vasoconstriction on Insulin-Mediated Microvascular Recruitment and Glucose Uptake in Obesity
NCT03953326 results posted 00011271 Ph 1, Ph 2 terminated HeartPhone Cancer Survivors Trial 2019
NCT04986072 results posted ALK3831-A309 Ph 2 terminated Sodium Nitroprusside in Early Course Schizophrenia
NCT05277922 results posted VP-C21-009 Ph 1 completed Effect of C21 on Forearm Blood Flow
NCT03679780 2018-0648 Ph 1 completed The Effect of Endothelin and L-Arginine on Racial Differences in Vasoconstriction
NCT03446612 results posted 205767 2017-002268-42 Ph 2 terminated Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)
NCT02767024 PRIORITY-ADHF 2014-3586 Ph 4 withdrawn Intravenous Vasodilator vs. Inotropic Therapy in Patients With Heart Failure
NCT02164981 results posted 2014P001204 Ph 2 completed A Proof of Concept Study of Intravenous Sodium Nitroprusside in Adults With Symptomatic Schizophrenia
NCT03680573 2017-0842 Ph 1 completed The Effect of Antioxidants on Skin Blood Flow-BH4
NCT00891696 08-306 R01AR049877 Ph 1 completed Nutritional and Contractile Regulation of Muscle Growth
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Active Pipeline

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Ongoing clinical trials by development phase

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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

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.

NIPRIDE RTU IN SODIUM CHLORIDE 0.9% FDA Label Details

Indications & Usage

FDA Label (PDF)

NIPRIDE RTU IN SODIUM CHLORIDE 0.9% is indicated for the treatment of Hypertension; Congestive Heart Failure.

⚠️ BOXED WARNING

BOXED WARNING Sodium nitroprusside injection is not suitable for direct injection. The solution must be further diluted in sterile 5% dextrose injection before infusion. Sodium nitroprusside injection can cause precipitous decreases in blood pressure (see DOSAGE AND ADMINISTRATION ). In patients not...

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Data Sources

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