Valproate Sodium Injection, Solution
NDC Package 63323-494-16

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

Valproate Sodium injection is • Valproate sodium injection should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions (5.1)]. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-494 and is authorized under FDA application ANDA076539.

Identification & Billing

NDC Package Code
63323-494-16
Package Description
10 VIAL, SINGLE-DOSE in 1 TRAY / 5 mL in 1 VIAL, SINGLE-DOSE (63323-494-41)
Product Code
63323-494
11-Digit Billing Format
63323049416
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Valproate Sodium
Non-Proprietary Name
Valproate Sodium
Substance Name
Valproate Sodium
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
• Valproate sodium injection should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions (5.1)]. • Valproate sodium injection is contraindicated in patients known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG; e.g., Alpers-Huttenlocher Syndrome) and children under two years of age who are suspected of having a POLG-related disorder [see Warnings and Precautions (5.1)].• Valproate sodium injection is contraindicated in patients with known hypersensitivity to the drug [see Warnings and Precautions (5.11)]. • Valproate sodium injection is contraindicated in patients with known urea cycle disorders [see Warnings and Precautions (5.6)].

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA076539
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-18-2003
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 (63323-494). Click a package code to view its specific billing and regulatory data.

63323-494-05
10 VIAL, SINGLE-DOSE in 1 TRAY / 5 mL in 1 VIAL, SINGLE-DOSE (63323-494-01)

* 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 63323-494-16 identifies a specific commercial package of 10 vial, single-dose in 1 tray / 5 ml in 1 vial, single-dose (63323-494-41) of Valproate Sodium, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution is formulated for intravenous use and contains valproate sodium 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 Fresenius Kabi Usa, Llc on August 18, 2003. The current certification is valid through December 31, 2026.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323049416. 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)
63323-494-16
11-Digit CMS (5-4-2)
63323-0494-16

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