Orbactiv
NDC Package 65293-015-03

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 discontinued by the firm.

Orbactiv is a medication an antibiotic used to treat serious bacterial infections of the skin. Marketed by The Medicines Company, this product is identified by NDC 65293-015 and is authorized under FDA application NDA206334.

Identification & Billing

NDC Package Code
65293-015-03
Package Description
3 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (65293-015-01)
Product Code
65293-015
11-Digit Billing Format
65293001503
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA

Clinical Specifications

Proprietary Name
Orbactiv
Dosage Form
-
Usage Information
This medication is an antibiotic used to treat serious bacterial infections of the skin. It works by stopping the growth of bacteria.

Regulatory & Marketing

Labeler Name
The Medicines Company
FDA Application #
NDA206334
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-01-2014
End Marketing Date
06-30-2021
Listing Expiration
06-30-2021
Exclude Flag
D
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 65293-015-03 identifies a specific commercial package of 3 vial, glass in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, glass (65293-015-01) of Orbactiv, labeled by The Medicines Company. This product is billed for "EA" each discreet unit and contains an estimated amount of 3 billable units per package. 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 The Medicines Company on September 01, 2014. The current certification is valid through June 30, 2021.

What are the primary indications for this medication?

This medication is an antibiotic used to treat serious bacterial infections of the skin. It works by stopping the growth of bacteria.

How is this The Medicines Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65293001503. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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)
65293-015-03
11-Digit CMS (5-4-2)
65293-0015-03

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