Methylene Blue Injection
NDC Package 70710-2083-5

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

Package Information

Methylene Blue injection is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.This indication is approved under accelerated approval. This formulation utilizes a injection delivery system. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 70710-2083 and is authorized under FDA application ANDA215636.

Identification & Billing

NDC Package Code
70710-2083-5
Package Description
5 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
70710-2083
11-Digit Billing Format
70710208305
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 10 mg/mL
Pharmacologic Class
Usage Information
Methylene blue injection 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
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA215636
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70710-2083). Click a package code to view its specific billing and regulatory data.

70710-2083-1
1 VIAL in 1 CARTON / 10 mL in 1 VIAL

* 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 70710-2083-5 identifies a specific commercial package of 5 vial in 1 carton / 10 ml in 1 vial of Methylene Blue, a human prescription drug labeled by Zydus Pharmaceuticals Usa 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 Zydus Pharmaceuticals Usa Inc. on April 01, 2026. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710208305. 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)
70710-2083-5
11-Digit CMS (5-4-2)
70710-2083-05

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