Valproic Acid Solution
NDC Package 0116-4021-11

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

Valproic Acid solution is a medication used to treat seizure disorders, mental/mood conditions (such as manic phase of bipolar disorder), and to prevent migraine headaches. This formulation utilizes a solution delivery system. Marketed by Xttrium Laboratories Inc., this product is identified by NDC 0116-4021 and is authorized under FDA application ANDA070868.

Identification & Billing

NDC Package Code
0116-4021-11
Package Description
10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4021-10)
Product Code
0116-4021
11-Digit Billing Format
00116402111
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
This medication is used to treat seizure disorders, mental/mood conditions (such as manic phase of bipolar disorder), and to prevent migraine headaches. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

Regulatory & Marketing

Labeler Name
Xttrium Laboratories Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA070868
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-1986
Listing Expiration
12-31-2027
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 (0116-4021). Click a package code to view its specific billing and regulatory data.

0116-4021-16
473 mL in 1 BOTTLE, PLASTIC
0116-4021-40
4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4021-05)
0116-4021-41
10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0116-4021-05)

* 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 0116-4021-11 identifies a specific commercial package of 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 ml in 1 cup, unit-dose (0116-4021-10) of Valproic Acid, a human prescription drug labeled by Xttrium Laboratories Inc.. 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 Xttrium Laboratories Inc. on July 01, 1986. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat seizure disorders, mental/mood conditions (such as manic phase of bipolar disorder), and to prevent migraine headaches. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

How is this Xttrium Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00116402111. 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 (4-4-2)
0116-4021-11
11-Digit CMS (5-4-2)
00116-4021-11

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