Valproic Acid Solution
NDC Package 81033-266-50

11-digit billing NDC: 81033026650 · Billing unit: ML · 500 ML per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Valproic Acid solution is 1.1 Epilepsy Valproic acid oral solution is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. This formulation utilizes a solution delivery system. Marketed by Kesin Pharma Corporation, this product is identified by NDC 81033-266 and is authorized under FDA application ANDA073178.

Identification & Billing

NDC Package Code
81033-266-50
Package Description
100 CUP, UNIT-DOSE in 1 CASE / 5 mL in 1 CUP, UNIT-DOSE (81033-266-05)
Product Code
81033-266
11-Digit Billing Format
81033026650
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
500 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Valproic Acid
Non-Proprietary Name
Valproic Acid
Substance Name
Valproic Acid
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VALPROIC ACID 250 mg/5mL
Pharmacologic Class
Usage Information
1.1 Epilepsy Valproic acid oral solution is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic acid oral solution is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. See Warnings and Precautions (5.1) for statement regarding fatal hepatic dysfunction. 1.2 Important Limitations Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable [see Warnings and Precautions (5.2, 5.3, 5.4), Use in Specific Populations (8.1), and Patient Counseling Information (17)]. For prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Contraindications (4)].

Regulatory & Marketing

Labeler Name
Kesin Pharma Corporation
Product Type
Human Prescription Drug
FDA Application #
ANDA073178
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-02-2024
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 (81033-266). Click a package code to view its specific billing and regulatory data.

81033-266-52
100 CUP, UNIT-DOSE in 1 CASE / 10 mL in 1 CUP, UNIT-DOSE (81033-266-10)

* 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 81033-266-50 identifies a specific commercial package of 100 cup, unit-dose in 1 case / 5 ml in 1 cup, unit-dose (81033-266-05) of Valproic Acid, a human prescription drug labeled by Kesin Pharma Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 500 billable units per package. This solution is formulated for oral use and contains valproic acid 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 Kesin Pharma Corporation on January 02, 2024. The current certification is valid through December 31, 2026.

How is this Kesin Pharma Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81033026650. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 500 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)
81033-266-50
11-Digit CMS (5-4-2)
81033-0266-50

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