Rapivab
NDC Package 61364-181-03

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Rapivab is indicated for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than 2 days.Limitations of Use:Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled. Marketed by Seqirus Usa Inc., this product is identified by NDC 61364-181 and is authorized under FDA application NDA206426.

Identification & Billing

NDC Package Code
61364-181-03
Package Description
3 VIAL, GLASS in 1 CARTON / 20 mL in 1 VIAL, GLASS (61364-181-01)
Product Code
61364-181
11-Digit Billing Format
61364018103
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rapivab
Dosage Form
-
Usage Information
RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than 2 days.Limitations of Use:Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled. Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RAPIVAB [see Microbiology (12.4)].The efficacy of RAPIVAB could not be established in patients with serious influenza requiring hospitalization [see Clinical Studies (14.3)].

Regulatory & Marketing

Labeler Name
Seqirus Usa Inc.
FDA Application #
NDA206426
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-20-2014
Listing Expiration
12-31-2021
Exclude Flag
I
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 61364-181-03 identifies a specific commercial package of 3 vial, glass in 1 carton / 20 ml in 1 vial, glass (61364-181-01) of Rapivab, labeled by Seqirus Usa Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Seqirus Usa Inc. on December 20, 2014. The current certification is valid through December 31, 2021.

How is this Seqirus Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61364018103. 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)
61364-181-03
11-Digit CMS (5-4-2)
61364-0181-03

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