Methylene Blue Injection
NDC Package 68462-698-15

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  is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. This formulation utilizes a injection delivery system. Marketed by Glenmark Pharmaceuticals Inc., Usa, this product is identified by NDC 68462-698 and is authorized under FDA application ANDA219550.

Identification & Billing

NDC Package Code
68462-698-15
Package Description
5 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (68462-698-10)
Product Code
68462-698
11-Digit Billing Format
68462069815
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methylene Blue
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 50 mg/10mL
Pharmacologic Class
Usage Information
Methylene blue injection is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.

Regulatory & Marketing

Labeler Name
Glenmark Pharmaceuticals Inc., Usa
Product Type
Human Prescription Drug
FDA Application #
ANDA219550
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-23-2025
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 68462-698-15 identifies a specific commercial package of 5 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose (68462-698-10) of Methylene Blue, a human prescription drug labeled by Glenmark Pharmaceuticals Inc., Usa. 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 Glenmark Pharmaceuticals Inc., Usa on December 23, 2025. The current certification is valid through December 31, 2027.

How is this Glenmark Pharmaceuticals Inc., Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68462069815. 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)
68462-698-15
11-Digit CMS (5-4-2)
68462-0698-15

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