Oxcarbazepine Tablet, Film Coated
NDC Package 0615-8567-39

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Oxcarbazepine tablets is oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy). This formulation utilizes a tablet, film coated delivery system. Marketed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs, this product is identified by NDC 0615-8567 and is authorized under FDA application ANDA215939.

Identification & Billing

NDC Package Code
0615-8567-39
Package Description
30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
0615-8567
11-Digit Billing Format
00615856739
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxcarbazepine
Non-Proprietary Name
Oxcarbazepine
Substance Name
Oxcarbazepine
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OXCARBAZEPINE 600 mg/1
Pharmacologic Class
Usage Information
Oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy).

Regulatory & Marketing

Labeler Name
Ncs Healthcare Of Ky, Llc Dba Vangard Labs
Product Type
Human Prescription Drug
FDA Application #
ANDA215939
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-11-2022
End Marketing Date
07-31-2026
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 0615-8567-39 identifies a specific commercial package of 30 tablet, film coated in 1 blister pack of Oxcarbazepine, a human prescription drug labeled by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. This tablet, film coated is formulated for oral use and contains oxcarbazepine 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 Ncs Healthcare Of Ky, Llc Dba Vangard Labs on January 11, 2022.

What are the primary indications for this medication?

Oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy).

How is this Ncs Healthcare Of Ky, Llc Dba Vangard Labs product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00615856739. 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 (4-4-2)
0615-8567-39
11-Digit CMS (5-4-2)
00615-8567-39

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