Nipride Rtu Injection, Solution
NDC Package 51754-1029-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nipride Rtu (sodium nitroprusside) injection is diseases with compensatory hypertension (e.g., coarctation of the aorta, arteriovenous shunting).Inadequate cerebral circulation or in moribund patients (A.S.A. This formulation utilizes a injection, solution delivery system. Marketed by Exela Pharma Sciences, Llc, this product is identified by NDC 51754-1029 and is authorized under FDA application NDA209387.

Identification & Billing

NDC Package Code
51754-1029-1
Package Description
1 VIAL in 1 CARTON / 100 mL in 1 VIAL
Product Code
51754-1029
11-Digit Billing Format
51754102901
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nipride Rtu
Non-Proprietary Name
Sodium Nitroprusside
Substance Name
Sodium Nitroprusside
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
SODIUM NITROPRUSSIDE .2 mg/mL
Pharmacologic Class
Usage Information
Diseases with compensatory hypertension (e.g., coarctation of the aorta, arteriovenous shunting).Inadequate cerebral circulation or in moribund patients (A.S.A. Class 5E) coming to emergency surgery.Patients with congenital (Leber’s) optic atrophy or with tobacco amblyopia.  Acute heart failure associated with reduced peripheral vascular resistance.Concomitant use with sildenafil, tadalafil, vardenifil, or riociguat. 

Regulatory & Marketing

Labeler Name
Exela Pharma Sciences, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA209387
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-20-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51754-1029-1 identifies a specific commercial package of 1 vial in 1 carton / 100 ml in 1 vial of Nipride Rtu, a human prescription drug labeled by Exela Pharma Sciences, Llc. This injection, solution is formulated for intravenous use and contains sodium nitroprusside as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Exela Pharma Sciences, Llc on July 20, 2018. The current certification is valid through December 31, 2026.

How is this Exela Pharma Sciences, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51754102901. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
51754-1029-1
11-Digit CMS (5-4-2)
51754-1029-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.