Onfi
NDC Package 67386-310-01

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.

Onfi is a medication used with other medications to help control seizures. Marketed by Lundbeck Pharmaceuticals Llc, this product is identified by NDC 67386-310 and is authorized under FDA application NDA202067.

Identification & Billing

NDC Package Code
67386-310-01
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE
Product Code
67386-310
11-Digit Billing Format
67386031001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Onfi
Dosage Form
-
Usage Information
This medication is used with other medications to help control seizures. It belongs to a class of medications called benzodiazepines, which act on the brain and nerves (central nervous system) to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).

Regulatory & Marketing

Labeler Name
Lundbeck Pharmaceuticals Llc
FDA Application #
NDA202067
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-21-2011
End Marketing Date
02-10-2017
Listing Expiration
02-10-2017
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 67386-310-01 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet in 1 bottle of Onfi, labeled by Lundbeck Pharmaceuticals Llc. 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 Lundbeck Pharmaceuticals Llc on October 21, 2011. The current certification is valid through February 10, 2017.

What are the primary indications for this medication?

This medication is used with other medications to help control seizures. It belongs to a class of medications called benzodiazepines, which act on the brain and nerves (central nervous system) to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).

How is this Lundbeck Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67386031001. 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)
67386-310-01
11-Digit CMS (5-4-2)
67386-0310-01

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