Revatio Injection, Solution
NDC Package 58151-395-31

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

Package Information

Revatio (sildenafil citrate) injection is sildenafil is used to treat high blood pressure in the lungs (pulmonary hypertension). This formulation utilizes a injection, solution delivery system. Marketed by Viatris Specialty Llc, this product is identified by NDC 58151-395 and is authorized under FDA application NDA022473.

Identification & Billing

NDC Package Code
58151-395-31
Package Description
1 VIAL in 1 CARTON / 12.5 mL in 1 VIAL
Product Code
58151-395
11-Digit Billing Format
58151039531
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Revatio
Non-Proprietary Name
Sildenafil Citrate
Substance Name
Sildenafil Citrate
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)
SILDENAFIL CITRATE .8 mg/mL
Pharmacologic Class
Usage Information
Sildenafil is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise. This medication is not recommended for use in children. Discuss the risks and benefits of this medication with the doctor.

Regulatory & Marketing

Labeler Name
Viatris Specialty Llc
Product Type
Human Prescription Drug
FDA Application #
NDA022473
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-09-2025
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 58151-395-31 identifies a specific commercial package of 1 vial in 1 carton / 12.5 ml in 1 vial of Revatio, a human prescription drug labeled by Viatris Specialty Llc. This injection, solution is formulated for intravenous use and contains sildenafil citrate 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 Viatris Specialty Llc on April 09, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Sildenafil is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise. This medication is not recommended for use in children. Discuss the risks and benefits of this medication with the doctor.

How is this Viatris Specialty Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58151039531. 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 (5-3-2)
58151-395-31
11-Digit CMS (5-4-2)
58151-0395-31

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