Argatroban Injection
NDC Package 83301-0500-1

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

Package Information

Argatroban injection is argatroban is contraindicated in:Patients with major bleeding, [see Warnings and Precautions (5.1)] Patients with a history of hypersensitivity to argatroban. This formulation utilizes a injection delivery system. Marketed by Mullan Pharmaceutical Inc., this product is identified by NDC 83301-0500 and is authorized under FDA application ANDA217848.

Identification & Billing

NDC Package Code
83301-0500-1
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE
Product Code
83301-0500
11-Digit Billing Format
83301050001

Clinical Specifications

Proprietary Name
Argatroban
Non-Proprietary Name
Argatroban
Substance Name
Argatroban
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)
ARGATROBAN 50 mg/50mL
Pharmacologic Class
Usage Information
Argatroban is contraindicated in:Patients with major bleeding, [see Warnings and Precautions (5.1)] Patients with a history of hypersensitivity to argatroban. Airway, skin, and generalized hypersensitivity reactions have been reported [see Adverse Reactions (6.1)]

Regulatory & Marketing

Labeler Name
Mullan Pharmaceutical Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217848
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83301-0500-1 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 50 ml in 1 vial, single-dose of Argatroban, a human prescription drug labeled by Mullan Pharmaceutical Inc.. This injection is formulated for intravenous use and contains argatroban 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 Mullan Pharmaceutical Inc. on January 01, 2026. The current certification is valid through December 31, 2027.

How is this Mullan Pharmaceutical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83301050001. 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)
83301-0500-1
11-Digit CMS (5-4-2)
83301-0500-01

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