Rapiblyk Injection, Powder, Lyophilized, For Solution
NDC Package 84381-110-01

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

Package Information

Rapiblyk (landiolol) injection is rAPIBLYK is indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Aop Orphan Pharmaceuticals Gmbh, this product is identified by NDC 84381-110 and is authorized under FDA application NDA217202.

Identification & Billing

NDC Package Code
84381-110-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Product Code
84381-110
11-Digit Billing Format
84381011001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rapiblyk
Non-Proprietary Name
Landiolol
Substance Name
Landiolol Hydrochloride
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
LANDIOLOL HYDROCHLORIDE 280 mg/1
Pharmacologic Class
Usage Information
RAPIBLYK is indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter.

Regulatory & Marketing

Labeler Name
Aop Orphan Pharmaceuticals Gmbh
Product Type
Human Prescription Drug
FDA Application #
NDA217202
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-07-2025
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 84381-110-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose of Rapiblyk, a human prescription drug labeled by Aop Orphan Pharmaceuticals Gmbh. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains landiolol hydrochloride 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 Aop Orphan Pharmaceuticals Gmbh on August 07, 2025. The current certification is valid through December 31, 2027.

How is this Aop Orphan Pharmaceuticals Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84381011001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
84381-110-01
11-Digit CMS (5-4-2)
84381-0110-01

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