Oxcarbazepine Suspension
NDC Package 65162-649-78

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Oxcarbazepine suspension is oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy). This formulation utilizes a suspension delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 65162-649 and is authorized under FDA application ANDA202961.

Identification & Billing

NDC Package Code
65162-649-78
Package Description
1 BOTTLE in 1 CARTON / 250 mL in 1 BOTTLE
Product Code
65162-649
11-Digit Billing Format
65162064978
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Oxcarbazepine
Non-Proprietary Name
Oxcarbazepine
Substance Name
Oxcarbazepine
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OXCARBAZEPINE 300 mg/5mL
Pharmacologic Class
Usage Information
Oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy).

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA202961
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-04-2012
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65162-649). Click a package code to view its specific billing and regulatory data.

65162-649-48
10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (65162-649-43)

* 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 65162-649-78 identifies a specific commercial package of 1 bottle in 1 carton / 250 ml in 1 bottle of Oxcarbazepine, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This suspension 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 Amneal Pharmaceuticals Llc on June 04, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65162064978. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
65162-649-78
11-Digit CMS (5-4-2)
65162-0649-78

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