Bivalirudin Injection
NDC Package 55111-652-37

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

Package Information

Bivalirudin injection is bivalirudin for injection is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). This formulation utilizes a injection delivery system. Marketed by Dr. Reddy's Laboratories Limited, this product is identified by NDC 55111-652 and is authorized under FDA application ANDA201577.

Identification & Billing

NDC Package Code
55111-652-37
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION in 1 VIAL, SINGLE-DOSE (55111-652-07)
Product Code
55111-652
11-Digit Billing Format
55111065237
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bivalirudin
Non-Proprietary Name
Bivalirudin
Substance Name
Bivalirudin
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intracavernous - Administration within a pathologic cavity, such as occurs in the lung in tuberculosis.
Active Ingredient(s)
BIVALIRUDIN 250 mg/1
Pharmacologic Class
Usage Information
Bivalirudin for injection is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA201577
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-31-2017
Listing Expiration
12-31-2026
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.

J0583
Source: PDAC
INJECTION, BIVALIRUDIN, 1 MG
HCPCS Dosage 1 MG
Units / Pkg

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55111-652-37 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 1 injection in 1 vial, single-dose (55111-652-07) of Bivalirudin, a human prescription drug labeled by Dr. Reddy's Laboratories Limited. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. This injection is formulated for intracavernous use and contains bivalirudin 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 Dr. Reddy's Laboratories Limited on May 31, 2017. The current certification is valid through December 31, 2026.

How is this Dr. Reddy's Laboratories Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55111065237. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 total billable units per package. 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)
55111-652-37
11-Digit CMS (5-4-2)
55111-0652-37

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