Oxcarbazepine
NDC Package 81033-113-30
Package Information
Oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy). Marketed by Kesin Pharma, this product is identified by NDC 81033-113 and is authorized under FDA application ANDA209652.
Identification & Billing
- RxCUI: 283536 - oxacarbazepine 300 MG in 5 mL Oral Suspension
- RxCUI: 283536 - oxcarbazepine 60 MG/ML Oral Suspension
- RxCUI: 283536 - oxacarbazepine 300 MG per 5 ML Oral Suspension
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 81033 - Kesin Pharma
- 81033-113 - Oxcarbazepine
- 81033-113-30 - 30 CUP, UNIT-DOSE in 1 CARTON / 5 mL in 1 CUP, UNIT-DOSE (81033-113-05)
- 81033-113 - Oxcarbazepine
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 81033-113-30 identifies a specific commercial package of 30 cup, unit-dose in 1 carton / 5 ml in 1 cup, unit-dose (81033-113-05) of Oxcarbazepine, labeled by Kesin Pharma. 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 Kesin Pharma on February 14, 2023. The current certification is valid through December 31, 2025.
What are the primary indications for this medication?
Oxcarbazepine is used alone or with other medications to treat seizure disorders (epilepsy).
How is this Kesin Pharma product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 81033011330. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.