Argatroban Injection
NDC Package 16729-430-43

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

Package Information

Argatroban injection is argatroban is contraindicated in: Patients with major bleeding [see Warnings and Precautions (5.1)]. This formulation utilizes a injection delivery system. Marketed by Accord Healthcare Inc., this product is identified by NDC 16729-430 and is authorized under FDA application NDA212035.

Identification & Billing

NDC Package Code
16729-430-43
Package Description
10 VIAL, SINGLE-USE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-USE
Product Code
16729-430
11-Digit Billing Format
16729043043
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

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 1 mg/mL
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
Accord Healthcare Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA212035
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-07-2021
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0891
Source: OPPS
Argatroban nonesrd (accord)
HCPCS Dosage 1 MG
Units / Pkg 500

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 (16729-430). Click a package code to view its specific billing and regulatory data.

16729-430-11
1 VIAL, SINGLE-USE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-USE

* 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 16729-430-43 identifies a specific commercial package of 10 vial, single-use in 1 carton / 50 ml in 1 vial, single-use of Argatroban, a human prescription drug labeled by Accord Healthcare 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 Accord Healthcare Inc. on October 07, 2021. The current certification is valid through December 31, 2027.

How is this Accord Healthcare Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16729043043. 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)
16729-430-43
11-Digit CMS (5-4-2)
16729-0430-43

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