Methylene Blue Injection, Solution
NDC Package 82449-002-06

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

Package Information

Methylene Blue injection is uSP is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. This formulation utilizes a injection, solution delivery system. Marketed by Steriscience Specialties Private Limited, this product is identified by NDC 82449-002 and is authorized under FDA application ANDA216955.

Identification & Billing

NDC Package Code
82449-002-06
Package Description
5 AMPULE in 1 CARTON / 10 mL in 1 AMPULE (82449-002-01)
Product Code
82449-002
11-Digit Billing Format
82449000206
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methylene Blue
Non-Proprietary Name
Methylene Blue
Substance Name
Methylene Blue
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)
METHYLENE BLUE 50 mg/10mL
Pharmacologic Class
Usage Information
Methylene blue injection, USP is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.

Regulatory & Marketing

Labeler Name
Steriscience Specialties Private Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA216955
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-28-2025
Listing Expiration
12-31-2027
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 82449-002-06 identifies a specific commercial package of 5 ampule in 1 carton / 10 ml in 1 ampule (82449-002-01) of Methylene Blue, a human prescription drug labeled by Steriscience Specialties Private Limited. This injection, solution 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 Steriscience Specialties Private Limited on February 28, 2025. The current certification is valid through December 31, 2027.

How is this Steriscience Specialties Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82449000206. 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)
82449-002-06
11-Digit CMS (5-4-2)
82449-0002-06

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