Bivalirudin Injection, Solution
NDC Package 70511-142-50

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

Bivalirudin injection is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. This formulation utilizes a injection, solution delivery system. Marketed by Maia Pharmaceuticals, Inc., this product is identified by NDC 70511-142 and is authorized under FDA application NDA211215.

Identification & Billing

NDC Package Code
70511-142-50
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE
Product Code
70511-142
11-Digit Billing Format
70511014250
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bivalirudin
Non-Proprietary Name
Bivalirudin
Substance Name
Bivalirudin
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
BIVALIRUDIN 250 mg/1
Pharmacologic Class
Usage Information
Bivalirudin Injection is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.

Regulatory & Marketing

Labeler Name
Maia Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA211215
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-27-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70511-142). Click a package code to view its specific billing and regulatory data.

70511-142-84
10 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE

* 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 70511-142-50 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 1 injection, solution in 1 vial, single-dose of Bivalirudin, a human prescription drug labeled by Maia Pharmaceuticals, Inc.. This injection, solution is formulated for intravenous 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 Maia Pharmaceuticals, Inc. on May 27, 2024. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70511014250. 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)
70511-142-50
11-Digit CMS (5-4-2)
70511-0142-50

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