Orgaran
NDC Package 76388-830-16

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.

Orgaran is a . Marketed by Aspen Global Inc., this product is identified by NDC 76388-830 and is authorized under FDA application NDA020430.

Identification & Billing

NDC Package Code
76388-830-16
Package Description
10 AMPULE in 1 CARTON / .6 mL in 1 AMPULE (76388-830-06)
Product Code
76388-830
11-Digit Billing Format
76388083016

Clinical Specifications

Proprietary Name
Orgaran
Dosage Form
-

Regulatory & Marketing

Labeler Name
Aspen Global Inc.
FDA Application #
NDA020430
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-09-2023
End Marketing Date
05-09-2023
Listing Expiration
05-09-2023
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 76388-830-16 identifies a specific commercial package of 10 ampule in 1 carton / .6 ml in 1 ampule (76388-830-06) of Orgaran, labeled by Aspen Global 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 Aspen Global Inc. on May 09, 2023. The current certification is valid through May 09, 2023.

How is this Aspen Global Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76388083016. 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)
76388-830-16
11-Digit CMS (5-4-2)
76388-0830-16

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