Quick answers
- What is Sodium nitroprusside used for?
- The FDA-approved label (Nipride Rtu, Exela Pharma Sciences, LLC, July 20, 2018) says: “Sodium nitroprusside is a direct acting vasodilator indicated for: • Immediate reduction of blood pressure • Producing controlled hypotension to reduce bleeding during surgery. • Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sodium nitroprusside have a boxed warning?
- Yes. The FDA label for Nipride Rtu has a boxed warning (“WARNING: (A) EXCESSIVE HYPOTENSION; (B) CYANIDE TOXICITY (A) EXCESSIVE HYPOTENSION”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Sodium nitroprusside?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sodium nitroprusside been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sodium nitroprusside?
- 13 companies list prescription products of Sodium nitroprusside in the FDA NDC Directory, including Hainan Poly Pharm. Co., Ltd., Slate Run Pharmaceuticals, LLC and Dr. Reddy's Laboratories Inc..
What Sodium nitroprusside is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Sodium nitroprusside is a direct acting vasodilator indicated for: • Immediate reduction of blood pressure • Producing controlled hypotension to reduce bleeding during surgery. • Treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure. …
— FDA label: Nipride Rtu, Exela Pharma Sciences, LLC, effective July 20, 2018. Read the full label on DailyMed →
The FDA has 17 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: (A) EXCESSIVE HYPOTENSION; (B) CYANIDE TOXICITY (A) EXCESSIVE HYPOTENSION
. Read it on the full label →
17 of 17 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution · Injection, solution, concentrate |
|---|---|
| Route | Intravenous |
| Prescription products | 22 in the FDA NDC Directory |
| Brand names | Nipride Rtu |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hainan Poly Pharm. Co., Ltd.4 products
- Slate Run Pharmaceuticals, LLC4 products
- Dr. Reddy's Laboratories Inc.2 products
- Mylan Institutional LLC2 products
- Exela Pharma Sciences, LLC2 products
- Caplin Steriles Limited1 product
- BE Pharmaceuticals Inc.1 product
- Micro Labs Limited1 product
- Meitheal Pharmaceuticals Inc.1 product
- Armas Pharmaceuticals Inc.1 product
- Somerset Therapeutics, LLC1 product
- AuroMedics Pharma LLC1 product
- Amneal Pharmaceuticals LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA209387 NIPRIDE RTU IN SODIUM CHLORIDE 0.9% | Exela Pharma | March 8, 2017 | 2, latest July 13, 2018 2018: Manufacturing (CMC) · 2018: Labeling |
Generic approvals (10)
- ANDA209493Amneal · November 7, 2017
- ANDA209352Micro Labs · December 8, 2017
- ANDA210763Mylan Labs Ltd · April 17, 2018
- ANDA210882Somerset Theraps LLC · August 17, 2018
- ANDA210114DR Reddys · April 10, 2019
- ANDA211016Caplin · November 29, 2019
- ANDA214199Hainan Poly · August 25, 2020
- ANDA211934Eugia Pharma · December 10, 2020
- ANDA214971Be Pharms · July 12, 2021
- ANDA215846Hainan Poly · August 26, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nipride Rtu, Exela Pharma Sciences, LLC, effective July 20, 2018; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →