Valproic Acid Solution
NDC Package 70752-202-12

11-digit billing NDC: 70752020212 · Billing unit: ML · 5676 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Valproic Acid solution is 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 Quagen Pharmaceuticals Llc, this product is identified by NDC 70752-202 and is authorized under FDA application ANDA090517.

Identification & Billing

NDC Package Code
70752-202-12
Package Description
12 BOTTLE in 1 CASE / 473 mL in 1 BOTTLE
Product Code
70752-202
11-Digit Billing Format
70752020212
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5676 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
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.

Regulatory & Marketing

Labeler Name
Quagen Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA090517
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-15-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70752-202-12 identifies a specific commercial package of 12 bottle in 1 case / 473 ml in 1 bottle of Valproic Acid, a human prescription drug labeled by Quagen Pharmaceuticals Llc. 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 Quagen Pharmaceuticals Llc on April 15, 2024. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70752020212. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 5676 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)
70752-202-12
11-Digit CMS (5-4-2)
70752-0202-12

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