Oxcarbazepine Powder
NDC Package 84855-005-00

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Oxcarbazepine powders is oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy). This formulation utilizes a powder delivery system. Marketed by Bajaj Healthcare Ltd, this product is identified by NDC 84855-005.

Identification & Billing

NDC Package Code
84855-005-00
Package Description
1 BAG in 1 DRUM / 20 kg in 1 BAG
Product Code
84855-005
11-Digit Billing Format
84855000500

Clinical Specifications

Proprietary Name
Oxcarbazepine
Non-Proprietary Name
Oxcarbazepine
Substance Name
Oxcarbazepine
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
OXCARBAZEPINE 20 kg/20kg
Usage Information
Oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy).

Regulatory & Marketing

Labeler Name
Bajaj Healthcare Ltd
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-07-2024
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 84855-005-00 identifies a specific commercial package of 1 bag in 1 drum / 20 kg in 1 bag of Oxcarbazepine (UNFINISHED drug), a bulk ingredient labeled by Bajaj Healthcare Ltd. This powder is formulated for 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 Bajaj Healthcare Ltd on December 07, 2024. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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

How is this Bajaj Healthcare Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84855000500. 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)
84855-005-00
11-Digit CMS (5-4-2)
84855-0005-00

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