Provayblue Injection
NDC Package 0517-0125-05

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

Package Information

Provayblue (methylene blue) injection is pROVAYBLUE ® USP is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. This formulation utilizes a injection delivery system. Marketed by American Regent, Inc., this product is identified by NDC 0517-0125 and is authorized under FDA application NDA204630.

Identification & Billing

NDC Package Code
0517-0125-05
Package Description
5 AMPULE in 1 CARTON / 2 mL in 1 AMPULE (0517-0125-01)
Product Code
0517-0125
11-Digit Billing Format
00517012505
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Provayblue
Non-Proprietary Name
Methylene Blue
Substance Name
Methylene Blue
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
METHYLENE BLUE 5 mg/mL
Pharmacologic Class
Usage Information
PROVAYBLUE ® USP is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials [ see Clinical Studies ( 14.1) ].

Regulatory & Marketing

Labeler Name
American Regent, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA204630
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-08-2020
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 0517-0125-05 identifies a specific commercial package of 5 ampule in 1 carton / 2 ml in 1 ampule (0517-0125-01) of Provayblue, a human prescription drug labeled by American Regent, Inc.. This injection is formulated for intravenous use and contains methylene blue 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 American Regent, Inc. on April 08, 2020. The current certification is valid through December 31, 2026.

How is this American Regent, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00517012505. 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 (4-4-2)
0517-0125-05
11-Digit CMS (5-4-2)
00517-0125-05

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